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
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