Obelis European Authorized Representative Center"CE Marking Consultants with a Reputation for Excellence"
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
Contact us now to find out more.