Are you compliant with the upcoming MDR and IVDR?

Following the transition from the Medical Device Directive (MDD) and Active implantable Medical Device Directive (AIMDD) to the MDR (MDR 2017/745), products with existing certificates can be marketed under the MDD until their certificates expire. For any certificates issued before 25th May 2017, the maximum date of expiratory is May 2022, and for any certificates issued after May 2017 the maximum expiratory date is 27th May 2024.  However, in most cases the certificates will expire sooner. 

If your CE marking certificates are currently issued under the MDD or AIMDD, now is the time to make sure that your documentation meets the standard of the MDR. 

Time is also running out for certification from the In Vitro Diagnostics Directive (IVDD) to the IVDR (IVDR 2017/746). Under the directives, 80% of in vitro diagnostic devices are self-certified and do not require a notified body. However, following the implementation of the IVDR on 26th May 2022, those devices that are up-classified and can no longer be self-certified cannot be legally marketed in the EU. 

We offer a gap analysis and technical file documentation, including a Clinical Evaluation Report service and can provide help and support wherever you are in your journey. For advice on how to fast-track your transition, contact our Regulation team at [email protected].