European Commission MDR QA

As the strain of coronavirus known as COVID-19 continues to spread and cause substantial disruption across Europe, EU regulators are seeking to delay enforcement of the new EU Medical Device Regulation (MDR) by 12 months.

Repealing the existing directives concerning medical devices, EU MDR came into force on the 25th May 2017 and saw all companies working with any medical devices given three transition years to meet the new MDR requirements.

With the deadline of the 26th May 2020 looming, many companies in the mobility, independent living and access industries have been working diligently to ensure their ranges conform to the many MDR obligations which span from stringent product labelling conditions to product liability insurance provisions.

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However, with the outbreak of coronavirus, companies hurrying to comply with MDR have struggled amid lockdowns in multiple countries globally and increased demand to quickly supply vitally needed equipment, such as beds, mattresses, ventilators and some medical PPE.

In the wake of the crisis, leading organisations representing the healthcare sector have called on the European Regulatory Institutions to postpone the deadline as the industry helps to battle the COVID-19 outbreak.

In a statement issued on the 23rd March, MedTech Europe, the European trade association representing the medical technology industries, said: “Currently and for the next few months, helping healthcare systems to overcome this outbreak is and will be in everyone’s top priority and focus.

“Manufacturers are striving to keep needed medical technologies available to healthcare systems while managing the effects of the pandemic on their organisations. This severely disrupts healthcare stakeholders’ efforts to implement the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulations (IVDR) within the fixed transition timelines, which expire on 26 May 2020 and 26 May 2022 respectively.”

Additionally, on the 24th March, the Socialists and Democrats (S&D) in the European Parliament spokesperson on medical devices, Biljana Borzan, said: “Put human lives first. In the midst of the dreadful Covid-19 crisis across Europe, all member states and their national health systems have the duty to do whatever it takes to save the greatest number of lives. We are very concerned with the shortage of some essential equipment in the fight against Covid-19 and therefore, we decided to formally request the postponement of the entry into force of the Regulation on Medical Devices.

“Although the regulation contains very important elements to improve patient safety, in these unprecedented times, the priority should be on meeting the demand for medical devices and equipment.”

With Europe now the epicentre of the global pandemic and mounting pressure to delay, the European Commission responded on the 25th March, confirming it is working on a proposal to postpone MDR enforcement by 12 months.

The proposal is set to be submitted in early April, with the Commission urging the European Parliament and Council to pass the postponement quickly.

For many suppliers and distributors of equipment classed as medical devices in the UK, a postponement would come as welcome news, allowing more time for the industry to focus on fighting more urgent fires and providing more time to prepare for the regulatory transformation.

Hear the Commission’s response below:

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