Medical Device Registration in EU-via Greece member of the European Union
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.
Categories included in the requirement are:
- Class I, Is, Im
- Class IIa, IIb, III
- Custom Made Devices
- Establish a European Authorized Representative (E.A.R.)
- Provide all required documents to E.A.R.
- E.A.R. proofs all documents and prepares them for submission
- E.A.R. submits required documentation to EOF
- E.A.R. provides proof of submission
- Products may circulate in the Greek market, provided acceptance by authorities
In order to maintain relationships free from mixed association (commercial vs. regulatory needs), the E.A.R. should be separate from the distributor for the following reasons:
- By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his product in the European Market (such as in Greece).
- Device registration is connected to the representative registering the product, therefore if it is decided to end the relationship with a commercial distributor at any point, it will be required to take the device completely off the market until a re-registration is completed for a second (third, fourth, etc.) time.
- A Third party commercial entity will expect exclusivity, limiting the open distribution of devices.
For the long-term benefit of the non-EU manufacturer, the Greek Registration should be done by the European authorized representative appointed to represent products in the European Union, being free from all commercial interests.
Additional national registrations and further requirements are becoming increasingly popular as European directives are transposed into national legislation (France, Portugal, Italy & Latvia), thus increasing the necessity for a single European Authorized Representative.