Medline Continuing to Prepare for the MDR Thanks to Successful BSI Audit
27 th July 2022
The EU’s Medical Device Regulation (MDR) came into force on 25 May 2017. This legislation replaces the EU’s current Medical Device Directive (MDD), namely 93/42/EEC and 90/385/EEC (active implantable medical devices). We are now in the transition period where both legal frameworks can be applied. However, as of 27 May 2024, only devices with an MDR certificate may be sold. Read more below on Medline’s preparedness for the MDR.
On 21 to 23 June in Châteaubriant, Medline International France successfully underwent a three-day audit by our notified body, BSI, to verify our compliance with the new Medical Device Regulation (MDR).
This quality system review was a mandatory step to obtain new CE certificates under the new MDR in advance of the May 2024 expiry of our MDD certificates. By completing the audit, we are confident that we will be able to fulfill the remaining requirements to obtain these certificates ahead of the MDR deadline.