European Union Medical Device Directive (MDD) to Medical Device Regulations (MDR) strategic transition

1. European Union Medical Device Directive (MDD) to Medical Device Regulations (MDR): strategic transition This is especially important subject in medical device world. Understand strategic transition, one needs to go in detail as what is MDD with respect to MDR, why transition? And what transition? MDD was labelled as directive, has quite relevant content but was not sufficient in view of rapidly changing technology which could deliver much advanced medical devices but also could have risk if it were regulated just by MDD. Objective of new MDR in broad category was to bring, improved consistency, better traceability, and transparency in regulatory process. Post market performance became particularly important aspect to judge newly designed advanced medical devices with modern technology. It is especially important to note that MDR is regulation as ‘R’ of MDR stands for regulation and it is must to adopt. New deadline for MDR compliance was 26thMay 2021. Now it is on and all those who are doing business of medical device in Europe has to see its compliance or else there will be huge implication on business. Let us see major changes in this transition from MDD to MDR. 1.Product lifecycle approach like US FDA. 2.Device re-classification. If your already existing device falls into other high category of class, there will be tremendous implication on its management and monitoring. 3.The new updated Post Market Surveillancerequirement. 4.General safety and performance requirement. 5.Clinical Evaluation requirement (CER) 6.Introduction of UDI (Unique device identification) 7.EUDAMED (EU databank on medical devices) All above requirements are not just one time activity but must be covered under QMS andyour existing QMS must be updated for risk management, clinical investigation/evaluation and post market surveillance. These changes implies to medical device industry in terms of training of your all employees with new QMS and its execution so they can amend documented system in QMS. As said above if device class is changed to higher level as per MDR reclassification, all requirements for new class then will be applicable. This may involve additional cost of compliance and may involve prohibitive cost to the same medical device which was already in market for long time at lower cost. This is big business challenge. If this new class calls for new clinical data, then it will be time consuming and costly too. As the advancement in modern technology forced authority to transit MDD to MDR, manufacturer should also look for modern technology in their improvement too like in manufacturing, QMS. An automation is one of the best approaches to avoid human error and faster solution for implementation so one can be ready for both announced and unannounced audit. Apart from transition steps mentioned above there are several existing process steps also need relook. Process may need re-design with the support of automation for better consistency and no-defect. PMS process gains lot of importance so attention must be given to that. Success of this depends on your improved risk management process, product testing with new changed specification, gathering new clinical evidence. Supply chain compliances with integrated approach to have perfect traceability.

2. PSUR (periodic safety update report) is an important activity required under PMS system and management must device system under which this activity continues and meeting reviews, discusses and implements CAPA. 1.Serious incidents and field safety corrective actions from PMS. 2.Non serious incidents and undesirable side effects. 3.Trend data analysis. 4.Scientific or technical literature review. 5.Feedback and customer complaints. 6.Information about similar medical devices. There is another report needed by MDR called PMSR (Post market surveillance report). Depending on class of your device one may need either PSUR or PMSR. Type Classification PMSR or PSUR Medical device Class I PMSR Upon Request Medical device Class IIA PSUR During Conformity assessment for Notified body review Medical device Class II B (non- implantable) Medical device Class II B (implantable) Review Medical device Class III all PSUR Via EUDAMED for Notified Body Review IVD Class A, B PMSR Upon Request IVD Class C PSUR During Conformity assessment for Notified body review IVD Class D PSUR During Conformity assessment for Notified body review Since PSUR report is very essential, following items are essential for PSUR report, 1.PMS Data 2.Conclusion of Benefit risk analysis 3.Description of CAPA and rational or justification of the same. 4.Findings of PMCF (Post market clinical follow up) 5.Device sales volume and estimated user population. 6.Frequency of device usage (if practical) 7.An analysis and summary of all above listed items. Similarly, PMS report is also needed to be regularly active activity. All manufacturers should capture data actively, analyse them and make results available to regulatory bodies. Some companies offer software to manage all such activities so one cannot miss any such time bound activities and reporting the same to regulatory bodies. Apart from above requirement it is obligatory on the part of manufacturer to ensure that, health and safety of user is not compromised due to defective, misleading, and dangerous products. When problem is detected, company should immediately take actions of Recall if needed. Develop a solution and keep users and regulatory body updated. Submission protocol Update frequency As Necessary Every 2 years at Minimum Every Year at Minimum PSUR During Conformity assessment for Notified body review PSUR Via EUDAMED for Notified Body Every Year at Minimum Every Year at Minimum As Necessary Every Year at Minimum Every Year at Minimum