• MDR 2020, ie The Medical Devices Regulation 2020, is a complex piece of legislation to replace MDD (Medical Device Directives). The transition started in May 2017, and was due to finish in May 2020.

    • There has been an enormous global effort across the industry to meet the new regulations by it's May 2020 deadline, when all previous MDD will become void. The EU MDR has been a source of stress and pressure for many medical device companies around the globe due to its stringent regulations overhauling much of the industry.

      In response to the COVID-19 pandemic adding extra stress however, the European Commission (the organisation that creates and implements regulatory decisions within the European Union) proposed a 1-year delay in MDR's implementation and enforcement in April. The European Parliament voted in April 2020 and officially approved and adopted the delay. The date of application is now May 26 2021. Other than the change of the Date of Application, there are no other changes to the MDR.

      • Why was the deadline pushed back? 


        The MDR deadline was pushed back because of the global COVID-19 pandemic. The goal of the EU MDR is to better serve public health, and the decision to delay its enforcement was made with the same goal in mind. This extra year that has been granted allows medical device companies more time to become compliant, and allows more space and capacity to prioritize COVID-19 efforts. The medical industry as a whole is generally stretched even at the best of times, but the pandemic has exacerbated already-strained budgets, resources and plans. By delaying the Date of Application, the European Commission has allowed any extra capacity to be devoted to tackling the pandemic, instead of becoming MDR compliant. 


        MDR threatening medical device supplies at a vulnerable time


        The COVID-19 outbreak and the public health crisis that it has created presents an unprecedented challenge for all those involved in the medical device industry. This includes authorities, health institutions, economic operators, manufacturers, as well as the citizens it applies to. The extraordinary circumstances that the COVID-19 pandemic has created demand substantial additional resources to cope with the increased strain. The crisis has also created the need for increased availability of vitally important medical devices. As these needs could not have been reasonably anticipated at the time of the adoption of the Regulation (2017), the delay was granted.

        Crucial equipment


        The European Commission noted that medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the fight against and control of the COVID-19 outbreak. The importance of these pieces of equipment in ensuring the health and safety of citizens is even more important given the pandemic. The EU MDR and its May 2020 deadline already threatened to temporarily reduce the number of products on the European market, as the numerous and more stringent standards would have forced companies to remove or delay products from the market if they weren't able to comply with the new regulations. This negative side effect was taken into account when planning for MDR 2020, but the overall benefits would have outweighed the cost in a regular market. This calculation of cost was revisited however when COVID-19 emerged, and taking any medical supplies off the market was deemed untenable and irresponsible.

        Working past the delay


        MedDev companies are recommended to plan proactively, and not reactively. It is predicted that the MDR delay will cause a cascade of other delays within the industry, further complicating compliance issues. Investing in strategic plans regarding all business, consumer, and compliance plans is highly recommended to survive the economic strain and public health hardship that accompanies a global pandemic. The delay does bring some relief to the companies that were struggling to meet the prior May 2020 deadline. It allows them more time to complete the transition to the new regulations. It will also give companies a chance to invest in higher quality operations and products. With higher quality goods and operations comes a host of positive effects, such as reduced regulatory burdens, higher production yields, lower failure rate, lower waste levels (financial and otherwise), reduced overheads, increased patient and stockholder trust and more.

        • Understanding ISO 14971:2019

          The updated Standard for the application of risk management to medical devices

        • Medical Devices Standards Management

          Rigid regulatory obligations leave no room for error in the Medical Devices industry

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