MDR

The new MDR regulation will apply from 26 May 2021. Get ready to ensure the compliance of your medical devices with the MDR.

MDR implementation

Defining your strategy for action, the required conformity assessment procedures and implementation methods for new products is key to ensuring MDR compliance efficiently and at the lowest possible cost.

MDR consulting

We offer support in obtaining the required documents for the marketing of new products prior to the application of the MDR, contact Notified Bodies and Competent Authorities for conformity assessment and notification procedures, and advising on the interpretation of the requirements of the MDR Regulation.

Person Responsible for Regulatory Compliance PRRC

Each manufacturer should have a person responsible for regulatory compliance in the organization who has the experience and the required expertise in the field of medical devices.

Manufacturer’s Insurance

Manufacturers of medical devices should put in place appropriate measures to ensure that there is sufficient financial coverage against any liability for damage caused by devices.