The Belgian competent authority (AFMPS/FAGG) has updated the form for the Free Sales Certificates (FSC) under the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR).
Medical devices and healthcare
Facility registration under MoCRA: who has to register and how to do it
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
Good manufacturing practices (GMP) for cosmetic producers explained
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
Understanding MoCRA: how to obtain a safety substantiation in the US
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
From FDA facility registration to US Agent: MoCRA step-by-step for the European cosmetic industry
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
EU Regulations on Medical Devices and IVD medical devices: What is the mandate and when do manufacturers need it?
Non-EU manufacturers can sell medical devices on the European Union market only if they appoint an authorised representative (EAR). Read more!
What is a PLIP and why is it required under MDR?
Article 10 (16) of the MDR obliges the manufacturer to have sufficient financial coverage for potential liability of defective medical devices. Read more!
What documents are required for EUDAMED Actor Registration?
Articles 31 of the MDR and Article 28 of the IVDR require all manufacturers, authorised representatives, and importers to register as actors on the EUDAMED database.
Reusable surgical instrument, a MDR legacy device?
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
3 tips to obtain IVDR certification
The EU IVDR (Regulation on in-vitro diagnostic devices) applies as of May 26, 2022, profoundly…