Understanding "free movement" for CE-marked products

[Quebec]

Hello all!

I am new here and will apologize in advance for asking a question I am sure was asked many times before - sadly searching through them has not yet really given me much clarity.

I am a newcomer in the corporate world having just finished a master's degree in biomedical engineering. The company I work for is going through audit for their CE-marking this week and hopefully all should soon be done and approved.

Assuming that is the case, and assuming we got the CE-marking through a Notified Body in a European country XYZ:
- Is it still necessary to follow country-specific commercialisation requirements across the EU? For example, for Portugal, products must be registered on the INFARMED online database. In Spain, a communication has to be submitted to the Regulatory Authority through the CCPS (Comunicación de Comercialización de Productos Sanitarios) online portal. In Italy, registration is required with the Ministry of Health database. Etc. etc. In other words, do we need to notify each country's Regulatory Authority even though we've already obtained CE-marking in another European country?

I hope that makes sense, and thank you very much in advance for your help in understanding these regulations

Best

 

[cfcruz]

Hi!

If you get a CE-marking through a Notified Body in the country XYZ, you need to register in the Competent Authority where the manufacturer or Authorised representative (if manufacturer from outside EU) is based. This registration may soon be through EUDAMED if that's the understanding of each of the Competent Authorities.

The requirements for registration in different countries is dependent on each country legislation, and therefore may vary from country to country. For class I most of the countries don't require you to register other than where in the Competent Authority where the manufacturer/authorised representative is based. For Portugal, products class I from other countries don't require registration, but class IIa, IIb, III and implantables require through INFARMED online portal (SIDM). I believe the requirements are similar in Spain while in Italy all classes require registration.

Also, another thing you should take into consideration is that other requirements may apply from each country as so far the legislation was transposed into each national law. One of such requirements is concerning language of the label and IFU (and user interface, if that exists), where most countries require it to be in their official language.

Good luck on the CE-mark certification audit!

 

[Quebec]

Hi cfcruz and thank you so much for your reply! Very helpful. All the best!