Downloads

In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746
Corrigendum to Regulation (EU) 2017/746 (2019-12)
In-Vitro Diagnostic Medical Devices Directive (98/79/EC)
Active Implantable Medical Devices Directive (90/385/EEC)
Cosmetic Products EC Regulation (No. 1223/2009)
Medical Device Regulation (EU) 2017/745
Corrigendum to Regulation (EU) 2017/745 (2019-12)
Medical Device Directive (93/42/EEC)
RoHS Directive (2011/65/EU)
Regulation (EU) No. 207/2012 on electronic instructions for use of medical devices
MedNet Certificate ISO 13485
MedNet Flyer EC Representation
MedNet Flyer EC Representation Cosmetic

Newsletter

12/2019: UK Responsible Person
12/2019: Importer and Distributor under MDR
11/2019: EUDAMED: European Databank on Medical Devices
08/2019: The new EN ISO 17664:2017
05/2018: Brexit: Impact of UK Withdrawal
09/2017: New Cosmetic Regulation No. 1223/2009
06/2017: New Medical Devices Regulation (MDR) No. 2017/ 745