Additional registration requirements for different EU-states on top of standard CE-registration?

[Son of Paperman]

I'm working for a Dutch company that designs and produces medical devices. Our products are CE-marked and registered with the competent authority (IGJ) for class 1 devices and with our notified body for class IIa, IIb and III. Our products class II & III have not yet been registered according to MDR but are still MDD compliant
According to the Dutch competent authority, products are registered in all EU member states as soon as the competent authority has entered our registration with them in EUDAMED.
We want to sell products in France and I have heard that despite what the competent authorities claim, additional registration activities still are required before the sales of medical devices is allowed in France (under MDD). If this is indeed the case, what extra actions are required where and with what institution?

Thank you very much in advance for your assistance.

 

[EmiliaBedelia]

Yes, you need to notify ANSM (French Agency for the Safety of Health Products) before you market your device. It is a fairly straightforward notification. There are a few countries that require additional in-country notification but in general they are all very simple (submit a form, DOC, maybe translated labels/IFU, etc).

FWIW, it is very easy to search online to figure out what the health authority is in a particular country, and that is generally the best resource to consult if you are looking for information on how to market in that country This website took me approx. 3 minutes to find, including the time it took to set my browser to translate to English.
Communiquer la mise en service pour la première fois en France - ANSM

 

[Ronen E]

including the time it took to set my browser to translate to English.

God bless AI.

 

[xcanals_tecno-med.es]

I supose this statement is not writen in the ductch law:

According to the Dutch competent authority, products are registered in all EU member states as soon as the competent authority has entered our registration with them in EUDAMED.

Is difficult to establish by a single compentent authority the legal requirements for others countries,
if not indicated in MDR, or their guidances MDCG, these statements are not valid

Read please the article 30.2 of the MDR:

2. Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory

In Spain we have also a requirement for medical devices (alos in the new project of Royal Decree which substitutes the transposition of the directives)
See the website of the Spanish Health Authorities AEMPS Sede Electrónica de la Agencia Española de Medicamentos y Productos Sanitarios - Sede Electrónica de la AEMPS (fees 105.10 Eur)