European CE Marking Strategy for Medical Devices
CE marking is very known requirement for those who are selling medical device in Europe. It is compulsory to have CE marking for all category of medical devices. This requirement is quite old and it was there even in MDD. However, with some additional new requirement in MDR, CE marking is slightly affected and one has to decide strategy for CE marking when transposing from MDD to MDR. MDD also required CE marking and there is hardly any change in the approach but as we all know that CE marking is an indication that the device meets current EU requirement of medical device this automatically makes process strategized. There are several changes happened from MDD to MDR which anyway all medical device manufacturer has to follow but CE marking process has not significantly but its requirement to meet current EU requirement makes all changes for manufacturers and marketeers also. Let us know simple steps where you can determine what needs to be done. First decide which set of regulation applies to your device, Medical device regulation (MDR 1017/745) or IVDR (invitro diagnostic regulation) or (IVD1017/746) Classification of your device as per MDR need to be reviewed based on risk assessment. Once the classification is complete one can know which regulation will apply. Establish QMS. MDR requirement should be incorporated in your existing QMS with appropriate amendments or new QMS to be made for those who start now. Create or review or renew your technical file to include all essential MDR requirement. This will also be a major change from MDD to MDR. In technical file review is very deep to check various dimensions including its appropriateness across its intended use, safety, labelling and packaging and effects of transportation and storage, risk v/s benefit for user. For class I, IIa and IIb class technical file contains,
Product description and specification Manufacturing information Risk management file Design verification and validation test reports Clinical evaluation Labelling
This process becomes smooth if QMS is strong. For class III design dossier is an additional requirement which includes complete design process apart from data and technical file.