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Medical Device Regulation Extension and Recalls

The Medicines and Healthcare products Regulatory Agency (MHRA) leads the charge on assuring the safety of medicines, medical devices and blood components for transfusion in the UK. Its core job is to ensure the products meet applicable standards of safety, quality and efficacy before they reach the hands of medical practitioners and patients.

Among the most highly regulated industries in the UK, and indeed across the world, both pharmaceuticals and medical device technology recalls are relatively common. In the last six weeks alone, the MHRA flagged six alerts for medical device tech. These included:

  1. Spinal fixation system which had a risk of implant failure prior to completion of the bone healing process.
  2. Bioprosthetic aortic heart valves with structural valve deterioration
  3. Defibrillator/Monitor with a failing therapy selector switch
  4. Monitor/Defibrillators that may fail to deliver therapy without alerting the user to a fault in the event of internal damage
  5. Ventilator with potential unexpected shutdown leading to loss of ventilation
  6. Lab based tests for COVID-19 antibodies using capillary blood sample collection kits which may not be reliable

The design of medical devices represents a major segment of the field of biomedical engineering, meaning that it is big business. Globally, the medical device market reached approximately US$425.5 billion in 2018. Europe has a 25% market share, with Germany, Italy, France and the United Kingdom all benefiting.

In response to the industry’s explosive growth the European Union published the Medical Device Regulation (MDR) on 5 May 2017 which then came into force on 25 May that same year. It was designed to supersede the Medical Device Directive and Active Implantable Medical Device Directive.

This meant that originally approved medicines would have a transition time of three years until May 2020 to meet the new MDR requirements. However, following COVID-19, the European Commission and European Parliament made the decision in April 2020 to postpone the deadline by one year.

A press release issued by the European Commission on 3 April stated: “Our priority is to support member states to address the coronavirus crisis and protect public health as powerfully as possible – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided.”

It is hoped that the postponement of the MDR will help countries avoid shortages in medical devices if the equipment were to be delayed for non-compliance. Improvements on traceability features and safety management of medical devices sold in Europe is the fundamental aim of the MDR. With the extension of time granted by the Commission, the industry has more scope to bring their products in line.

This means in-country authorities will continue monitoring medical devices in their own markets, shouldering the responsibility of the health of their citizens during the global pandemic.

It is a significant responsibility to undertake, and there will be issues along the way, but they have been doing the job for some time already and citizens of Europe should take comfort that in-country regulators are doing their utmost in these unprecedented times.

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