IVDR

The In Vitro Diagnostic Regulation will apply from 26 May 2021. Get ready to ensure your medical devices comply with the IVDR.

IVDR implementation

Defining a strategy for action, the required conformity assessment procedures and methods for the implementation of in vitro diagnostic medical devices is crucial to ensure compliance with the IVDR efficiently and at the lowest possible cost.

IVDR Consulting

We offer support in obtaining the required documents for the implementation of in vitro diagnostic medical devices prior to starting to apply the IVDR, contacting notified bodies and competent authorities with regard to conformity assessment procedures and advising on IVDR requirements.

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.