Registration in Greece
All medical devices, including IVDs that are to be placed on the Greek market, must be registered with the Greek Ministry of health (EOF) in accordance with Greek transposition of MDD 93/42/EEC, as published in the Greek Government Gazette, number 2198, dated 2 October 2009.
- 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 the 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 laid down by national legislation (France, Portugal, Italy & Latvia), thus increasing the necessity for a single European Authorized Representative.
On 26 May 2021, Medical Device Regulation (EU) 2017/745 will repeal Medical Device Directive 93/42/EEC. Until EUDAMED database allowing registration at EU level is functional, current- Directive registration process will continue. Nevertheless, Member States might continue requesting a separate registration to their national database.
For more information on the mandatory pre-market CPNP notification of your cosmetic products, have a look here!
Food supplements may be subject to the requirements of the national registration as a pre-market authorization. For more information, contact us today!
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