One more step towards a strong UKCA regulatory framework for Medical
After the withdrawal of the United Kingdom from the EU on January 31, 2020, the UK was separated from the European Union. While the country retained the core of many EU laws, such as the Medical Devices Regulations (MDR) 2002, which is based on the Medical Device Directive 93/42/EEC, the United Kingdom would be considered a separate entity.
This separation extended to medical devices and IVDs. One of the duties of the UK Medicines and Healthcare products Regulatory Agency (MHRA) was to ensure there would be organisations capable of assessing whether manufacturers conform to MDR 2002. Therefore, these organisations take the role of issuing the relevant certifications for affixing the UKCA mark of certain medical devices, showing compliance with MDR and allowing manufacturers to place their devices in the UK market.
These organisations are the UK equivalent of the EU Notified Bodies, being thus called UK Approved Bodies.
Their role and tasks vary depending on the classification of the medical devices and the conformity assessment route a manufacturer has chosen. Until recently, only three Approved Bodies were designated by the MHRA: BSI Assurance UK Ltd, SGS United Kingdom Ltd, and UL International (UK) Ltd. Now a new UK Approved Body has been designated by the MHRA, DEKRA Certification UK Ltd. This new UK Approved Body assesses general medical devices (also known as Part II designation).
What is quite important to note is that DEKRA is the first UK Approved Body to be designated after Brexit. This means it had to undergo a new designation process to gain the status of an Approved Body and be capable of certifying medical devices in the UK.
The MHRA hailed this development as “a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health” (Gov.UK, 2022). Additionally, it was noted that six organisations are currently in the assessment process, and several others have expressed interest in participating.
The previously explained progress on UK Approved Body designations was followed up by an MHRA announcement on October 25 that the standstill period (under which CE-marked devices are accepted) would be extended from June 2023 to June 2024. It indeed becomes apparent that the MHRA is quickly taking deliberate steps to cement a solid regulatory framework concerning medical devices. These developments follow on the footsteps of future regulatory guidance releases, e.g. on Software and AI as medical devices.
UK Approved Bodies ensure the conformity of manufacturers to the relevant regulations and guarantee a safer medical device market. In this sense, Obelis UK provides a UK Approved Body selection service on behalf of clients, getting in direct contact with UK Approved Bodies and ensuring the best-suited conformity route for compliance projects.
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Nikolaos Chatzistavrou
Regulatory Affairs Department
09/11/2022
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References:
- MDLaw. (October 27, 2022). UK Medical Device Regulations (mdlaw.eu). Retrieved on 09/11/2022.
- Obelis UK. (October 28, 2022). New MHRA guidance on software and AI as a medical device change programme – Obelis UK Ltd.. Retrieved on 09/11/2022.
- Gov. UK. (October 25, 2022). Implementation of the Future Regulations – GOV.UK (www.gov.uk). Retrieved on 09/11/2022.
- Gov. UK. (December 31, 2020). Approved bodies for medical devices – GOV.UK (www.gov.uk). Retrieved on 09/11/2022.
- Gov. UK. (September 2, 2022). UK approved bodies for medical devices – GOV.UK (www.gov.uk). Retrieved on 09/11/2022
- Gov. UK. (September 29, 2022). MHRA appoints first new UK Approved Body to certify medical devices since Brexit – GOV.UK (www.gov.uk). Retrieved on 09/11/2022
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