Registration of medical devices in Greece

[atourni4]

Dear all,

I'm coming to you for a question related to the requirements in Greece in terms of registration/notification of medical devices to the Greek competent authority.
We are a manufacturer of medical devices based in France. Our devices are class IIa medical devices (certified according to the MDD) and class I medical device (certified according to the MDR). We already sell our devices in several countries in Europe and we plan on starting the commercialization in Greece.

We already translated the user manual in Greek. My question is simple yet complicated: what do we need to do in terms of registration/notification to the Greek competent authority (EOF)?
I've seen mentions to an online database is to be used to notify, but also mentions of an email address to send the required documentation, I've seen mentions that manufacturers should make the notification and mentions that the distributor should do it... I would be very gratefull if someone can be of any help on this subject.

Thank you in advance.
Best regards.

 

[SteTop]

Dear all,

I'm coming to you for a question related to the requirements in Greece in terms of registration/notification of medical devices to the Greek competent authority.
We are a manufacturer of medical devices based in France. Our devices are class IIa medical devices (certified according to the MDD) and class I medical device (certified according to the MDR). We already sell our devices in several countries in Europe and we plan on starting the commercialization in Greece.

We already translated the user manual in Greek. My question is simple yet complicated: what do we need to do in terms of registration/notification to the Greek competent authority (EOF)?
I've seen mentions to an online database is to be used to notify, but also mentions of an email address to send the required documentation, I've seen mentions that manufacturers should make the notification and mentions that the distributor should do it... I would be very gratefull if someone can be of any help on this subject.

Thank you in advance.
Best regards.

Also interested to hear the answer. Anyone?

 

[KShaw]

I personally don't have experience with Greece's notification system, however, unless someone on this forum can provide you with more specifics, I'd recommend getting in touch with your distributor based in Greece who should know the ins and outs of the system and may even be able to communicate with the Competent Authority in Greece.

Best of luck.

 

[Jakub Milcarski]

There is no requirement for manufacturers located within EU and want to commercialize their products in Greece to register their products to the Greek CA. Since they have a valid CE mark they can be commercialised. This applies to manufacturers who sell directly their products to end users. If the manufacturer uses a distributor then the distributor is required to notify the devices to the Greek Competent Authority (EOF).

 

[SteTop]

Thanks everybody for help!

 

[SteTop]

Do you guys also know how it is working for following countries:
- Austria
- Germany
- France
Is there any special requirements for device "registration"?

 

[Nigel-S]

Dear all,

I'm coming to you for a question related to the requirements in Greece in terms of registration/notification of medical devices to the Greek competent authority.
We are a manufacturer of medical devices based in France. Our devices are class IIa medical devices (certified according to the MDD) and class I medical device (certified according to the MDR). We already sell our devices in several countries in Europe and we plan on starting the commercialization in Greece.

We already translated the user manual in Greek. My question is simple yet complicated: what do we need to do in terms of registration/notification to the Greek competent authority (EOF)?
I've seen mentions to an online database is to be used to notify, but also mentions of an email address to send the required documentation, I've seen mentions that manufacturers should make the notification and mentions that the distributor should do it... I would be very gratefull if someone can be of any help on this subject.

Thank you in advance.
Best regards.

I am also hearing from some distributors facing a 2% fee from EOF based on turnover. Have you also been approached with this fee?