Here we inform you about events and news on reimbursement and regulatory issues.
Manufacturers holding a Medical Device Establishment Licence (MDEL) for Canada were contacted by Health Canada in December and the Annual Licence Review (ALR) Package was submitted with it.
EUDAMED is the database developed by the European Commission for the registration of economic actors and their medical devices.
The update of product group 08 insoles and product group 32 therapeutic activation devices was recently published.
DIN EN 62366 Usability according to Annex C: A closer look at the standard to help manufactureres plan accordingly.
DIN EN ISO 10651-5 (Project)
DIN EN ISO 11073-10101
DIN EN ISO 28399 (Draft)
DIN 33402-2
ISO 9241-971
DIN EN 10942 rev (Project)
Update: From July 2021 on a separate individual code must be requested for each aid in France.
