European Authorized Representative Services

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Obelis (ISO Certified and E.A.A.R. member) services include: E.A.R. services, CE marking consulting, EU Harmonized Standards Identification, P.M.S, Free Sales Certificate, GMDN Code Research, Device Registration, Trade Mark Submission, and more.

Device Classification Confirmation Services

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.

MDD 93/42/EEC Services

Services offered by Obelis in accordance to the Medical Device Directive 93/42/EEC and its amendment 2007/47/EC include, but are not limited to European Authorized Representative services (EC Rep), pre-market notification of Class I devices and notification of the preliminary clinical investigations, post market advisory services, pre-CE marking services, free sales certificate services, certificate of CE registration, and GMDN code research services.

Medical Custom Made Services

Obelis European Authorized Representative Center (O.E.A.R.C.) provides 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 over 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.

Medical KITS Services

IVDD 98/79/EC Services

Services offered by Obelis in accordance with the In-Vitro Diagnostics Directive 98/79/EC include, but are not limited to European Authorized Representative services (EC Rep), pre-market notification to the Member State Competent Authority (per Member State), post market advisory services, pre-CE marking services, free sales certificate services, certificate of CE Registration, and GMDN code research services.

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.

MSD 98/37/EC Services

Services offered by Obelis in accordance with the Machinery Safety Directive 98/37/EC and its amendment 2006/42/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

Cosmetic 76/768/EEC Services

Services offered by Obelis in accordance with the Cosmetics Directive 76/768/EEC include, but are not limited to European Authorized Representative services, pre-market notification with Member State authorities and anti-toxic centers (per Member State) ,post market advisory services, and more.

EMC 2004/108/EC Services

Services offered by Obelis in accordance with the Electromagnetic Compatibility Directive 2004/108/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

LVD 2006/95/EC Services

Services offered by Obelis in accordance with the Low Voltage Directive 2006/95/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

R&TTE 1995/5/EC Services

Services offered by Obelis in accordance with the Radio and Telecommunications Terminal Equipment Directive 1995/5/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

GPSD 2001/95/EC Services

Services offered by Obelis in accordance with the General Products Safety Directive 2001/95/EC include, but are not limited to European Authorized Representative services, post market advisory services, free sales certificate services and more.

PPE 89/686/EEC Services

Services offered by Obelis in accordance with the Personal Protective Equipment Directive 89/686/EEC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

CPD 89/106/EEC Services

Services offered by Obelis in accordance with the Construction Products Directive 89/106/EEC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and more.

PED 97/23/EC Services

Services offered by Obelis in accordance with the Pressure Equipment Directive 97/23/EC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

TSD 88/378/EEC Services

Services offered by Obelis in accordance with the Toy Safety Directive 88/378/EEC include, but are not limited to European Authorized Representative services, post market advisory services, pre-CE marking services, and free sales certificate services.

US Agent Services

The primary function of a U.S. Agent as defined in the federal regulations is to serve as a point of contact for the FDA in communicating with a foreign device manufacturer. The U.S. Agent must have a domestic U.S. street address (no post office box number). The U.S. Agent will be contacted, whenever the FDA cannot contact the manufacturer directly. The U.S. Agent will also assist in scheduling FDA inspections of the manufacturer’s facilities.

Free Sales Certificate Services

Many non-European countries request a personalized Free Sales Certificate from the manufacturer in order to place their device within that specific country.

CD of Essential Requirements for MDD & MSD

Services for Device Registration in France

Under the Decree n° 2002-1221 September 30, 2002 and Decree n°2010-270 March 15, 2010, four categories of medical devices require to be registered with the French Agency for the Sanitary Security of Health Product (AFSSAPS) at the time of being put into service within French territory (click here for official letter by AFSSAPS).

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.

Services for Device Registration in Latvia

Under the Latvian Regulation No. 581 adopted on 2 August 2005 by Cabinet of Ministers, three categories of medical devices require to be registered with the State Agency of Medicines of Latvia (ZVA) at the time of being put into service within Latvian territory. (Please see Article 1 General Provision, paragraph 20 of the Regulation No. 581)

Categories of medical devices concerned by this obligatory communication are:

1. Class IIb medical devices
2. Class III medical devices
3. Active implantable medical devices (AIMDD)

Services for Device Registration in Greece

In accordance with Greek transposition of MDD 93/42/EEC, as published in the Greek Government Gazette, number 2198, dated 2 October 2009; article 14, paragraph 1, all medical devices must be registered with the Greek Ministry of health (EOF) before being placed on the market in Greece.

Services for Device Registration in Portugal

According to Article 11 of Decree-Law No. 145/2009 published on 17 June, 2009 and transposed into Portuguese law Directive No. 2007/47/CE of European Parliament and Council, ALL CLASSES of Medical Devices (Class I exempt) must be registered online with the national regulatory authority, INFARMED.

Services for On-Site Training

Obelis is pleased to announce a new service offering dedicated training sessions by our regulatory team on site at our clients’ premises. Such on-site training can be dedicated to the general framework and requirements of the Directive as well as specific training aimed at our clients’ specific situation or requests.

Services for GMDN Code Verification

The GMDN (Global Medical Device Nomenclature) Agency, is an international non-profit organisation which has been appointed by its stakeholders, Medical Device Regulators and Industry, to manage the GMDN database and maintain the nomenclature.

Trade Mark Services

Obelis offers the possibility to register your trade mark and design in the EU. As a non-European manufacturer, you need to appoint a European Representative to register your trade mark and community design.

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.

Post Market Surveillance

Systematic procedure to review experience gained from devices in the post-production phase” MEDDEV 2.12-1 rev 4 April 2001 Post Market Surveillance (P.M.S.) is a continuous product assessment designed to give the manufacturer ongoing feedback about the efficacy of their product. Analysis can lead to design improvements, safety innovations, and increased understanding of consumers.