Preparing for the Future: The New European Union Medical Devices Regulation

1. Preparing for the Future: The New European Union Medical DevicesRegulation An Academic presentationby Dr. Nancy Agens, Head, Technical Operations, Pepgra Group: www.pepgra.com Email:sales@pepgra.com

2. Today'sDiscussion OUTLINE OFTOPICS In Brief Introduction EU-MDR Preparing for the Future Approach to EU-MDRConformity In-Depth Understanding of the EU-MDR and EU-IVDR (Step –1) Review and Evaluation of Medical Device Portfolio (Step – 2) Strategy and Roadmap for new EU-MDR (Step –3) FutureScope

3. InBrief For long, medical device regulations continued to remain stagnant till such time that the world was struck with the hip replacement and breast implantcrisis. The new EU-MDR and EU-IVDR brings in more stringent regulations, drastically modifying the way in which medical device manufacturers operate. The new regulations have also modified several device classes that were previously quite lenient into classes that now require strict review and evaluation. It also takes into its ambit accessories to medical devices that were previouslyunregulated.

4. Introduction Right from the early 1990s, there has hardly been any changes in terms of regulation of the medical device industry withinEurope. Nonetheless, owing to some incidents during the recent past, comprising of the crisis revolving around hip replacements and breast implants has now incited the need for stringent compliance and regulatory reforms within theindustry. The most prominent amongst all regulations were the European Commission’s 2012 proposal for regulation on medical devices(EU-MDR) and in-vitro diagnostics(EU-IVDR). In the event that medical device manufacturers fail to conform to the changes, it would most probably lead to the medical device manufacturer forfeiting its manufacturinglicense.

5. EU-MDR The new EU-MDR 2017/745 brings legislation in EU at par with technical developments, modifications within medical science and advancements in terms oflaw-making. Implementation of the new EU-MDRwould eventually establish a regulatory framework that is transparent, robust and sustainable, which will receive global recognition, thereby enhancing clinical safety and facilitates manufacturers with an access to market. The new EU-MDR would restrict any discrepancies in terms of interpretation throughout the EUmarket.

6. Preparing for theFuture The European Commission has of late published five documents with the intention ofproviding guidance to manufacturers as well as other economic operators with regards to the changes effected through the new EU-MDRandEU-IVDR. They said guidance related documents comprise of implementation models as well as factsheets for medical device manufacturers as well as in-vitro medical device manufacturers, along withan extensive list of requirements for medical devicemanufacturers. Those manufacturers who have not commence execution of the new EU-MDR can refer tothese guidance documents as an initial roadmap, whereas, those manufacturers who have already progressed with the execution can refer to it as achecklist. Certain devices have also been reclassified on the basis of risk analysis while introducinga procedure of consultation on clinicalevaluation.

7. Approach to EU-MDRConformity Considering the intricacy and extent linked with executing the new EU-MDR, it is imperative that manufacturers adopt a cross-functional approach which extends across theenterprise. Essentially, there would be three steps to execute and adhere to the new EU- MDR and acquiringconformity.

8. In-Depth Understanding of the EU-MDR and EU-IVDR(Step-1) It would be necessary that medical devicemanufacturers have an enhanced understanding of the new EU-MDR, its overall impact and scope on theirbusiness. Several manufacturers would be having an amalgamation of products therefore the proposed modifications make sense. It would also be significant to comprehend any overlap with other pertinent directives and regulations such as clinical trial regulation(CTR) for human use and IVDetc.

9. Review and Evaluation of Medical Device Portfolio (Step-2) The entire gamut of products manufactured by a manufacturer needs to be necessarily evaluated and reviewed in line with the EU-MDR and requirements of thefuture. For instance, as per the new regulation those products that have been categorized as accessories would fall under the ambit of medicaldevices. There is also scope that as per new requirements, classification status of certain products mightchange. It would be imperative to understand whether such products need to be up-classified in future and its correspondingimpact.

10. Strategy and Roadmap for new EU-MDR (Step-3) Following the complete review and evaluation of the product portfolio as per the existing and future states, it would be possible to define gaps. Such gaps can be necessarily categorized as tactical and strategical projects, which can be prioritized on the basis of legal, business and regulatory drivers. To structure a regulatory strategy for affecting the new EU-MDR, there is a need for device manufacturers to define a logical sequence of activities.

11. FutureScope Medical devices that have not been covered under EU-MDR such as products that are known to utilize viable biological components for its intended purpose should also be included under the ambit of EU-MDR and EU-IVDR.

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