When does the MDR apply?
The MDR regulation will apply from 26 May 2021. The regulation will replace current directives 93/42/EEC and 90/385/EC. Manufacturers, importers and distributors therefore have little time to prepare for the more stringent requirements of the new regulations.
Which products are covered by the MDR?
The product scope covered by the regulation includes the following product groups:
- medical devices,
- active implantable medical devices,
- products that are a combination of a medicinal product or a medicinal substance and a medical device,
- products manufactured using non-viable or non-viable tissue or cell derivatives of human origin,
- groups of products which serve exclusively aesthetic or other non-medical purposes.
How can we help?
Identifying a strategy for action, the required conformity assessment procedures and methods to implement new products is key to ensuring MDR compliance efficiently and at the lowest possible cost.