Jul 10, 2020

UK medical device regulators have developed a list of medical devices without CE Marking that are legally available for use by healthcare providers and patients.

Medical devices can only be placed on the European market if they are CE-marked, unless one of the following conditions applies:

  1. It is a custom-made device; the CE Mark is intended to allow devices to move freely across the European Union market. Custom-made devices are intended to be supplied by their manufacturers directly to the patient/user, and therefore they are not intended for free movement.
  2. It is an investigational device; the investigation of safety and performance is part of the conformity assessment procedure required for CE Marking. In order to do this there are procedures to ensure the risks related to exposing EU citizens to devices not carrying the CE Mark are controlled.
  3. The device is derogated from CE-marking; there are two routes that may cause the need to accept the use of a device without CE-marking for which the two above scenarios are not applicable: an individual patient requires the use of a specific device or a product is not certified but there is a public health risk if this device is not made available.

Effects of COVID-19

The COVID-19 pandemic has made clear that a disruption in supply of just a handful of devices can have significant effects on the continuity of care. For example, a shortage in a minor accessory to a ventilator may limit the use of a specific type of machine, threatening the capacity of multiple hospitals. Because medical devices are often used in complex procedures and in well-thought-out combinations with other products, these cascade effects can be significantly more far-reaching than for medicinal products.

 

Learn more about European MDR compliance and timelines

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MDR Article 59

European lawmakers have developed Regulation (EU) 2020/561 amending Article 59 of the MDR. Article 59 covers Member States exempting devices used on their territory from CE Marking. It has been changed to allow the European Commission to expand the use of devices to other markets once a device has been exempted from CE Marking in one Member State. This will not only allow for fast responses to challenges in a situation like the coronavirus pandemic, but also help in other situations such as the man-made Brexit problem. Although the date of application of the MDR has been moved to 2021, the implementation of Article 59 MDR has been brought forward to April 24, 2020. Therefore it is interesting to see how the European Commission will deal with devices that are exempted from CE Marking in one or more Member States, and how fast this process will proceed. At this moment it appears there are no implementing acts proposed to support this aim.

The UK MHRA’s plan

From that perspective it is interesting to see that the UK Medicines & Healthcare Products Regulatory Agency (MHRA) appears to be preparing for a hard Brexit. MHRA has a well-designed and effective derogation procedure and the results are now publicly available. This list contains over 50 devices or device families and helps UK citizens to verify if a device without CE Marking can be used. In case there are problems with device supplies as a result of Brexit – possibly on top of problems caused by the COVID-19 pandemic – this procedure and its list can help in allowing devices to remain available for British healthcare providers.

Emergo expects other Member States will soon create their own lists, and it is likely the first Article 59 MDR-related implementing act will soon be published.

Related European MDR resources from Emergo by UL:

  • EU Medical Devices Regulation preparation and compliance resource center
  • Brexit transition consulting for medical device and IVD manufacturers
  • Whitepaper: Preparing for a no-deal Brexit

Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL.

Author

  • Ronald Boumans

Related

MHRA Guidance on a No-Deal Brexit

EMERGO BY UL SUMMARY OF KEY POINTS:

  • MHRA will take on responsibility for the UK market;
  • The CE Mark remains valid in the UK and no label changes are foreseen for now;
  • MDR and IVDR will be implemented in the UK in parallel with the EU
  • Non-UK manufacturers placing devices on the UK market need to appoint a UK Responsible Person, a role similar to that of the European Authorized Representative
  • The UK-based manufacturer or the UK Responsible Person must register the device in the UK.
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