In Brief

• For long, medical device regulations continued to remain stagnant till such time that the world was struck with the hip replacement and breast implant crisis.
• 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 previously unregulated.  

Right from the early 1990s, there has hardly been any changes in terms of regulation of the medical device industry within Europe. 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 the industry. 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). With the publication of guidance in a formal manner very imminent, the proposal intends to offer national regulators with a control that is much more superior and also provide any inherent oversights within the medical devices sector, while rendering it mandatory to conform to the new regulations (Doloitte, 2016). 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 manufacturing license.

The impact that would be created by the new EU-MDR could bring about drastic modifications to the manner in which medical device manufacturers function. So much so, that it has the potential to make an impact on the composition of the device manufacturers current as well future portfolios. Further, conforming to the regulations would also result in substantial costs. Therefore, it becomes imperative that device manufacturers act now in order to acquire buy-in by stakeholders, ready their organizations and commence with adopting the suggested modifications.

The new EU-MDR 2017/745 brings legislation in EU at par with technical developments, modifications within medical science and advancements in terms of law-making. Implementation of the new EU-MDR would 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 which is fair. In contrast to directives, it is not necessary to transpose regulations within national law. Thus the new EU-MDR would restrict any discrepancies in terms of interpretation throughout the EU market (European Commission, 2020). It can be thus said that the new EU-MDR is preparing the medical devices market for the future. However, there are aspects that medical device manufactures need to take into consideration in preparation of the future.

Preparing for the Future

The European Commission has of late published five documents with the intention of providing guidance to manufacturers as well as other economic operators with regards to the changes effected through the new EU-MDR and EU-IVDR which are due to be in-force from May, 2020 and May, 2022 onwards respectively. The 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 with an extensive list of requirements for medical device manufacturers (Grow, 2020). Those manufacturers who have not commence execution of the new EU-MDR can refer to these guidance documents as an initial roadmap, whereas, those manufacturers who have already progressed with the execution can refer to it as a checklist in order to ensure that they cover all steps within their plan of action.

The factsheet concentrates on key modifications as outlined by the EU-MDR and provides insights on the scope of the EU-MDR, definitions, obligations of manufacturers, class of risks for devices, notified bodies, system of identification of new devices, evaluation of adherence, along with clinical needs and a brief of clinical and safety performance. It offers vital points on the EU-MDR background, modifications executed through the new regulations and practical outcomes and the timelines for making the modifications. In addition, the guidance document also presents answers to some basic operational queries.

Furthermore, what needs to be taken into consideration is that the new EU-MDR outlines strict requirements for designating notified bodies (Grow, 2020). Also, the new EU-MDR has an extended scope and takes into its ambit more devices such as; devices for cleaning, sterilizing or disinfecting other medical devices, medical devices for single use that are reprocessed and some specific devices that have no intended medical purpose. Moreover, certain devices have also been reclassified on the basis of risk analysis while introducing a procedure of consultation on clinical evaluation. This is purportedly executed by a panel of independent experts for certain classes of devices (class IIb) and for devices falling under the implantable (class III) category (Grow, 2020). 

Approach to EU-MDR Conformity

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 the enterprise. Essentially, there would be three steps to execute and adhere to the new EU-MDR and acquiring conformity.

Acquiring and in-depth understanding of the EU-MDR and EU-IVDR (Step – 1)

It would be necessary that medical device manufacturers have an enhanced understanding of the new EU-MDR, its overall impact and scope on their business. 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 IVD etc.

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 the future. For instance, as per the new regulation those products that have been categorized as accessories would fall under the ambit of medical devices. There is also scope that as per new requirements, classification status of certain products might change. It would be imperative to understand whether such products need to be up-classified in future and its corresponding impact (Doloitte, 2016).

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. This warrants the need for an approach that is multi-level and would comprise of; impact evaluation of the highest levels, planning, execution and organizational alignment, communication and realization of benefits.

Future Scope

In future, 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.

References

1. Doloitte (2016). Taking charge of the new medical device regulatory environment: From complex regulation to impactful change. [Online]. 2016. Available from: https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-eu-med-device-regulation.pdf.


2. European Commission (2020). Internal Market, Industry, Entrepreneurship and SMEs. [Online]. 2020. Available from: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/getting-ready-new-regulations_en.


3. Grow (2020). Factsheet for manufacturers of medical devices. [Online]. 2020. European Commission. Available from: https://ec.europa.eu/docsroom/documents/31201.

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