Device Classification Confirmation Services

In Reference to the European New Approach Directives, it is imperative for the manufacturer of a product/device/apparatus/ piece of equipment to be placed on the European Market to firstly classify their products under European Regulation, whether it is a medical device, an in-vitro diagnostic medical device, an active implantable medical device,  a low voltage product with or without electromagnetically compatibility, a radio and telecommunication apparatus, machinery,  cosmetics, personal protective equipment, pressure equipment, a construction product, a toy or any combination of such – it must be classified before it is to be regulated!

One of the most concrete examples of the importance of proper classification resides in the MDD 93/42/EEC which requires of medical device manufacturers to classify their devices before placing their products in the European Union.  This classification is extremely important and will determine the compliance route for CE marking and market placement. 

The two major factors in determining the class of a medical device are the claimed intent of use and the mode of operations.  Annex IX of the MDD93/42/EEC outlines 18 rules of classification.  These include:

Rule 1 – Devices that either do not touch the patient or contact intact skin only
Rule 2 – Channeling or storing for eventual administration
Rule 3 – Devices that modify biological or chemical composition of blood, body liquids or other liquids
Rule 4 – Devices in contact with injured skin
Rule 5 – Devices invasive in body orifices
Rule 6 – Surgically invasive devices for transient use except if there are reusable surgical instruments
Rule 7 – Surgically invasive devices for short term use
Rule 8 – Surgically invasive devices for long term use and implantable devices
Rule 9 – Active therapeutic devices intended to exchange or administer energy
Rule 10 –Active devices for diagnosis
Rule 11 – Active devices to administer, remove medicines and other substances to or from the body
Rule 12 – All other active devices
Rule 13 – Devices incorporating a medicinal substance
Rule 14 – Devices used for contraception or prevention of sexually transmitted diseases.
Rule 15 – Specific disinfecting, cleaning and rinsing devices
Rule 16 – Non-active devices to record X-ray diagnostic images
Rule 17 – Devices utilizing animal tissues or derivatives
Rule 18 – Blood bags

Classes are established in accordance with the potential risk to the patient:

Class I-Medical Devices are regarded as “low risk” devices, e.g. non-evasive medical devices that do not touch the patient or contact skin only. Pre-market notification is required prior to placing the devices onto the EU market.

Class I sterile-Medical Devices are regarded as “low risk” devices, e.g. sterile non-evasive medical devices that do not touch the patient or contact skin only. Certification by a Notified Body in respect to sterilization process is required. Pre-market notification is required prior to placing the devices onto the EU market.

Class I measuring- Medical Devices are regarded “low risk” devices, e.g. non-invasive medical devices with a measuring function.  Certification by a Notified Body in respect to measuring function is required. Pre-market notification is required prior to placing the devices onto the EU market.

Class IIa-Medical Devices are regarded as “low-medium” risk devices, e.g. active therapeutic devices intended to administer or exchange energy in a non hazardous way. Certification by a Notified Body is required.

Class IIb-Medical Devices are regarded as “medium-high” risk medical devices, e.g. active devices for monitoring of vital physiological parameters. Certification by a Notified Body is required.

Class III-Devices are regarded as “high-risk” devices, e.g. devices incorporating a medicinal substance. Certification by a Notified Body is required.

Once a medical device has been properly classified a European Authorized Representative will be appointed (for Non-EU manufacturers) and a European Notified Body will be able to proceed with the required conformity tests applicable to the manufacturer’s device.

IT IS THE SOLE RESPONSIBILITY OF THE MANUFACTURER TO CLASSIFY HIS DEVICES AS PER EUROPEAN REGULATION!

Clinical evidence of a manufacturer’s classification must be provided.  Any medical device classification made by a manufacturer can be contested by a European Notified Body.  Medical devices that are not classified or are determined to be improperly classified are forbidden entry or removed from the European Market.  To assist manufacturers in this sometimes complicated or unclear process Obelis European Authorized Representative Center (O.E.A.R.C.) is proud to introduce a NEW service -  Confirmation of Classification.  Obelis European Authorized Representative Center (O.E.A.R.C.) will contact the competent authorities of an EU Member State in the manufacturer’s behalf to obtain a confirmation of the device classification.

Obelis Device Classification Services will:
• Simplify your transition into the EU Marketplace
• Put to rest class disputes with third parties (European Notified Bodies, Potential Clients, etc.)
• Clarify “borderline” devices
• Provide a European Recognized classification confirmation for your device

Click here to contact us for further information and to learn how to receive “Device Classification Confirmation Request Forms”.

AIMDD 90/385/EEC Services

Obelis European Authorized Representative Center provides superior quality representation, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services
European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community.
Guidance on Self-Declaration release
Market incident reporting and complaint handling coordination ( AIMDD 90/385/EEC)
Product labeling compliance: European Authorized Representative address on the device related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labelling compliance ( AIMDD 90/385/EEC)
Notification of the preliminary Clinical Investigations (AIMDD 90/385/EEC Annex 6) following the procedure referred to in Annex 7
Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked device is properly put on the EEA.

Advisory services
Ongoing language maintenance and glossary development   (for over 40 different languages)
Device listing and registration according to European Member State national requirements
Technical File documentation review
Guidance on QMS implementation
Guidance on product safety consultancy
Guidance on product testing and certification services
Identification of proper regulation
Identification of EU harmonized standards
Post market surveillance assistance
Regulatory advice and updates

“Pre-CE marking” services
Identification of product classification
Identification of the appropriate notified body
Coordination between the manufacturer and the notified body

Additional services:
Free Sales Certificate services
Certificate of CE Registration (Related to products which require Notification)
GMDN code research services
For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

 

 

 

 

 

 

CD of Essential Requirements for MDD & MSD

As you may know the 2007/47/EC amended the MDD 93/42/EEC which may have an immediate impact on the compliance of your medical devices in Europe.

There are two main amendments that are particularly important.

1. A decreasing of the importance of the Medical Device Directive 93/42/EEC in respect to all other European Directives.

2. The influence of the Machinery Safety Directive on the MDD 93/42/EEC (medical devices with moving parts), which will result in the combination of essential requirements in regards to both Directives.

• Both of which will be in full force by March 21st, 2010.

Obelis has created a CD presenting the following valuable guidelines:

• A table of essential requirements for MDD and MSD, written by Dr. Peter N. Ruys, one of the initial officials to implement the Medical Device Directive in Europe.

• A consolidated version of the Directives MDD 93/42/EEC with the amendments from Directive 2007/47/EC

• A Consolidated table of Essential Requirements of the MDD 93/42/EEC & the 2007/47/EC – NEW!

• The MSD 2006/42/EC

• A list of the European Standards under EU Machinery regulation

We are confident this CD will assist you in your understanding of the implementation of these new amendments.

You can order this CD by emailing us at .

As an Obelis client you may purchase the CD at a discounted rate of €150.00(euro).

Do not hesitate to contact us with any questions or concerns.

Services for Device Registration in Italy

Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 27 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation. 

An example of such local implementation of the Directive is now present in Italy which requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process. This process is similar to the pre-market notification requirement for Class I Medical Devices (as stated in the European Directive MDD 93/42/EEC Article 14) only in Italy it is applicable for all classes, not only Class I.

As a non-EU manufacturer of medical devices, you are required to use a European (legal) representative to register your medical device with the Italian database.  Non-Italian (European) manufacturers are also required to complete this registration themselves or appoint a legally-mandated representative to register for them.

This representative will communicate with the Italian Ministry of Health on your behalf. The registration can only be done with granted access to the Italian Database, and with the required “smart card” for the actual registration. Your legal representative needs to have access to both.

Third party commercial entities, like distributors, should not register your medical devices for several reasons, a few of which are:

1.    By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his medical device in Italy
2.    If you decided to end the relationship with your commercial distributor at any point, you would be required to take your medical device completely off the market until you could re-register that medical device within Italy for a second (third, fourth, etc.) time
3.    Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device

Conclusion:

1.    For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs
2.    The manufacturer should register their medical devices with the Italian database through his appointed Authorized Representative

Local Legislations like the example of Italy are growing rapidly in Europe (such as in Portugal) and strengthen the need for a professional European Authorized Representative present at all times.

CLICK HERE to receive further information about procedures and needed documentation for Obelis to complete Italian Device Registration in your behalf.

Free Sales Certificate Services

According to the European Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, CE marked and properly registered devices in all 27 EU member states and 4 EFTA countries have free access to the EU market (according to Article 14 MDD 93/42/EEC as amended by the 2007/47/EC and Article 10 IVDD 98/79/EC). Thus, once your device is properly CE marked, it is allowed to circulate and be sold throughout the European Union.

However, the CE Marking only enables penetration to the European market and does not enable the device to be placed on other global markets.

Due to the high standards of health and safety required by the CE Marking, customers in non-EU countries request a Free Sales Certificate from the manufacturer to demonstrate the device meets the various safety and health requirements specified by the CE Marking. The Certificate will enable the device to penetrate the market of the relevant country and be freely sold to the public (presuming all local requirements are also met).

As the manufacturer is not within the European territory and cannot communicate with the Authorities, this certificate can only be obtained through the manufacturer’s legal entity in Europe, the Authorized Representative.

In order to get the Free Sales Certificate for MDD and IVD devices, two conditions need to be met:

1. The device must bear the CE Marking
2. The manufacturer has appointed a European Authorized Representative for his device

Additionally:

If the device(s) are CE marked, but not properly notified/registered with the European Authorities by the appointed European Authorized Representative (as required by Law for MDD Class I and IVD devices), the CE Marking is NOT valid and therefore the Free Sales Certificate cannot be issued.

To receive a Free Sales Certificate, you will be required to present your Authorized Representative with the following:

• Information about the device
  • Name and form of the device
  • Classification (according to EU regulation)
  • Composition and description
• CE Certificate
• Information about the manufacturer
  • Name and contact details
  • Production Site
• Contact details for Notified Body

Trade Mark Services

“CTMR 88 (1), (2) The Community Trade Mark Regulation obliges natural and legal persons not having their domicile or their principal place of business or a real and effective industrial or commercial establishment in the Community to be represented, in all proceedings before the Office other than the filing of a CTM application, by a professional representative, namely either a legal practitioner or a person whose name is entered on the list of professional representatives maintained by the Office”.

Through its extended network of collaborators, OEARC can now provide you with cost effective and simplified trade mark and design registration for the entire EU.

TSD 88/378/EEC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (TSD 88/378/EEC)
• Product labeling compliance: European Authorized Representative address on the toy related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (TSD 88/378/EEC)
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked toy is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European member state national requirements
• Technical File documentation review
• Guidance on QMS implementation
Guidance on product safety consultancy
• Guidance on product testing and certification services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

PED 97/23/EC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (PED 97/23/EC)
• Product labeling compliance: European Authorized Representative address on the product related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (PE Directive 97/23/EC)
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked product is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European member state national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

 

CPD 89/106/EEC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (CPD 89/106/EEC)
• Product labeling compliance: European Authorized Representative address on the product related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (CPD 89/106/EEC)
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked product is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European member state national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

 

PPE 89/686/EEC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (PPE Directive 89/686/EEC)
• Product labeling compliance: European Authorized Representative address on the equipment related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (PPE Directive 89/686/EEC)
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked equipment is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European member state national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

GPSD 2001/95/EC Services

Obelis European Authorised Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (GPSD 2001/95/EC)
• Product labeling compliance: European Authorized Representative address on the product related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (GPSD 2001/95/EC)
• Observance of the compliance of the non-EU manufacturer at all times, once the product is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European member state national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services

Services we can also provide

 

Free Sales Certificate services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

R&TTE 1995/5/EC Services

Obelis European Authorised Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (R&TTE Directive 1999/5/EC)
• Product labeling compliance: European Authorized Representative address on the equipment related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (R&TTE Directive 1999/5/EC)
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked equipment is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European member state national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

 

LVD 2006/95/EC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (LVD Directive 2006/95/EC)
• Product labeling compliance: European Authorized Representative address on the electrical equipment related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (LVD Directive 2006/95/EC)
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked electrical equipment is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European member state national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

 

EMC 2004/108/EC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (EMC Directive 2004/108/EC)
• Product labeling compliance: European Authorized Representative address on the electrical equipment related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (EMC Directive 2004/108/EC)
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked electrical equipment is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European Member State national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

 

 

MSD 98/37/EC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (MSD 98/37/EC)
• Product labeling compliance: European Authorized Representative address on the machinery related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (MSD 98/37/EC)
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked machinery is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European member state national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

Cosmetic 76/768/EEC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• File preparation for the Notification Dossier to be submitted to the EU Authorities per EU member state
• Organize a Safety Assessment by an external assessor of the cosmetic product
• Pre- Market Notification of products per EU member state
• Notification to Anti-Toxic Centers per EU member state
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (Cosmetics Directive 76/768/EEC)
• Product labeling compliance: European Authorized Representative address on the product related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (Cosmetics Directive 76/768/EEC)
• Observance of the compliance of the non-EU manufacturer at all times, once the product is properly put on the European market

Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European Member State national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

IVDD 98/79/EC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Pre-market notification (registration) of product(s) on behalf of a non-EU manufacturer, according to the IVDD 98/79/EC In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC, Annex III, 5)
• Market incident reporting and complaint handling coordination (IVDD 98/79/EC, Annex III, 5)
• Product labeling compliance: European Authorized Representative address on the device related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (IVDD 98/79/EC, Annex I, 8.4 (a))
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked device is properly put on the European market

Advisory services

 

Ongoing language maintenance and glossary development   (for over 40 different languages)

Device listing and registration according to European Member State national requirements

Technical File documentation review

Guidance on QMS implementation

Guidance on product safety consultancy

Guidance on product testing and certification services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services
• Certificate of CE Registration (Related to products which require Notification)
• GMDN code research services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

 

MDD 93/42/EEC Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.

European Authorized Representative Services

• European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
• Guidance on Self-Declaration release
• Market incident reporting and complaint handling coordination (MDD 93/42/EEC)
• Product labeling compliance: European Authorized Representative address on the device related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (MDD 93/42/EEC)
• Pre-market notification (registration) of devices on behalf of a non-EU manufacturer, according to the specific EU regulation requirements that the devices should comply with.
  • Notification of Class I devices (MDD 93/42/EEC Article 14)
  • A breakdown of the notification procedure of Class I devices is available here
  • Notification of the preliminary Clinical Investigations (Annex X) following the procedure referred to in Annex VIII
  • A breakdown of the notification procedure of Clincial Investigation is available here
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked device is properly put on the EEA.


Advisory services

• Ongoing language maintenance and glossary development   (for over 40 different languages)
• Device listing and registration according to European Member State national requirements
• Technical File documentation review
• Guidance on QMS implementation
• Guidance on product safety consultancy
• Guidance on product testing and certification services
• Identification of proper regulation
• Identification of EU harmonized standards
• Post market surveillance assistance
• Regulatory advice and updates

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• Free Sales Certificate services
• Certificate of CE Registration (Related to products which require Notification)
• GMDN code research services

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.

 

US Agent Services

Regulatory Services include:

Obelis’ US Agent

All device manufacturers must identify an Official Correspondent for FDA who will be contacted by FDA, whenever the FDA has a question about the company or its products. This individual may be someone within the company or an outside consultant. As part of our on-going commitment to better serve our U.S. Agent clients, Obelis’ US Agent, at the client’s request, will also serve as their Official Correspondent at no additional charge. While it is acceptable to identify a company employee as the Official Correspondent, for reasons of language and time zone differences, FDA prefers to communicate with someone located inside the U.S.

Preparation and/or review of Establishment Registration and Device Listing forms

All device manufacturers must register all of their establishments and devices with the FDA, before the devices can be legally marketed in the U.S. These registrations must be updated annually or whenever a significant change occurs. As an additional service to our clients, O.U.A. will prepare and/or review these forms and submit them to the FDA. Again, this service is provided at no additional charge, provided the client uses O.U.A. as their U.S. Agent.

Compliance with the U.S. Medical Device Reporting (MDR) regulations

Reporting Adverse Events: All product complaints must be assessed for MDR applicability. The reporting rules are complex with unique forms and requirements. They also change regularly. O.U.A. will assist clients in assessing complaints received from the field and ensure that the proper procedures are followed and, if necessary, that the proper forms are completed and that the FDA is properly notified. There is no additional fee to sign up for this service, and all U.S. Agent clients of O.U.A. receive a reduced rate for each complaint evaluation.

Post Market Surveillance

The European Commission obliges all manufacturers to have in place a Post Market Surveillance System as referred to in General Product Safety Directive (crossing Personal Protective Equipment, Low Voltage Devices, Toys, Devices emitting Electromagnetic waves, and Cosmetics) Article 5, the Medical Device Directive Annexes II-VII, and In-Vitro Device Directive Annexes III, IV, VI and VII.

In regards to P.M.S., the European Commission defines it as a way “to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times” MEDDEV 2.12-1 rev 4 April 2001.

Conducted either proactively or retroactively PMS can take the form of:

• Focus Groups
• Customer surveys
• Customer complaints and warranty claims
• Post CE-market clinical trials
• Literature reviews
• User feedback
• Device tracking/implant registries
• User reactions during training programs
• The media
• Experience with similar devices made by the same or a different manufacturer
• Maintenance/service reports
• Retrieval studies on explants or trade-ins
• In-house testing
• Failure analysis

 

Environmental Directives Services

GiDoS Green Regulatory Center is a quality driven, service oriented company dedicated to assisting European and non-European manufacturer’s successful compliance with Environmental Directives and Regulations within Europe.

Based upon in-depth research and years of regulatory experience, GiDoS experts will work with you to orchestrate a complete Environmental Regulatory Strategy; thus implementing solutions for full compliance during the entire duration the product/device resides on the European market. Additionally, GiDoS offers tailored compliance services for the WEEE, RoHS and P&PW, as well as Only Representative services under REACH 1907/2006.

European “Green” Directives and Regulations are becoming prevalent and crucial points of interest for anyone involved in placing products on the European market. A comprehensive Environmental Strategy is necessary to study and satisfy the requirements you are constrained to abide by.

Our Services for WEEE 2002/96/EC, RoHS 2002/95/EC, and P&PW 94/62/EC:

GiDoS examines country’s regulations and European directives to identify the environmental requirements for your product(s) per product, per country.

• Upon request, GiDoS can keep you updated on member-state requirements of all EU countries you export to and notify you of any regulatory changes that might affect your product(s).
• GiDoS identifies the necessary marking and labeling requirements for your product(s) according to the European environmental directives.
• GiDoS investigates the recovery and treatment requirements of individual European member-states for WEEE and present you with different options for the recovery of your product(s).
• GiDoS compares the substances in your product(s) with the hazardous substances limited by the RoHS directive and identify which substances you need to replace or eliminate.
• GiDoS provides instruction on what to include in your records on the mass of WEEE components, materials, and substances according to WEEE 2002/96/EC Art. 10, 11.
• GiDoS explains how to complete the process of producer registration required by the directives.
• GiDoS provides guidance on guaranteeing the recycling, energy, composting, and biodegradation requirements of the P&PW directive.

Contact us now to find out more.

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