I just arrived back from an exciting visit to Dubai where Obelis team visited ARAB HEALTH! Of course, the main topic of conversation with medical devices’ manufacturers was the MDR and whether or not they are ready to embrace it!
In many conversations that we had, especially with manufacturers of Class I medical devices, there was confusion on the applicability of the MDR. Most of them were thrown off by the announcement of the European Commission on the delay of EUDAMED (European Databank on Medical Devices) to May 2022.
This announcement has led many manufacturers to believe that the application of the MDR in general has been postponed until 2022, while that is in fact not the case at all! MDR will be fully applicable for Class I manufacturers from the implementation date – 26 May 2020, with the only exception that registration in EUDAMED is not yet possible. Please be aware that existing registration process under the MDD will highly likely continue until the full operationality of EUDAMED.
So which actions do Manufacturers have to take to be MDR COMPLIANT for the EU market?
· Review your Quality Management and Risk Management Systems [Article 10 and ISO 13485:2016]
· Comply with new safety and performance requirements – Annex I
· Update your Technical Documentation to align with MDR Annex II and III;
· Review your Clinical Evaluation Plan and Report [Article 61 and Annex XIV];
· Assign UDI-DI and Basic UDI-DI to your devices;
· Sign mandate with a professional Authorized Representative;
· Designate Person Responsible for Regulatory Compliance;
· Modify labelling, IFUs, promotional materials of your devices + translate into EU languages of the market;
· Sign quality agreements with your importers and distributors;
· Comply with Post-market surveillance requirements [MDR Articles 83-92];
· Contract liability insurance;
To find out more about how Obelis can help in making sure you are compliant when the MDR comes into force, talk to our team of European regulatory and compliance experts. To get a quote on any of our services, contact Obelis today!
José Amsing
Senior Consultant
13.02.2020