Medical Device Regulatory System Update

Home 5 News 5 Medical Device Regulatory System Update

AVM Services would like to share the following summary concerning current issues with new regulations on medical devices.

Medical Device Regulatory System Update

1. With the withdrawal from the EU, the EU regulatory system was no longer active in the UK except for Northern Ireland. A new system of UK CA marks has been introduced using the existing MDR regulations which were the previous EC regime. In addition, companies with existing CE marks have been allowed to continue selling into the UK market.

2. In the EU the medical device regulatory system is transitioning from the MDD (medical device directive) to the MDR (medical device regulation). This requires all companies who wish to continue selling in Europe to undertake a new technical file audit. The transition period was to end in March 2024 however due to the complexity of the new regulations and the lack of appropriate auditors it has become clear that most existing devices will not have made the transition by March 2024. As a result, the EC now proposes to extend the deadline to end 2028 for more risky devices such as implants and 2029 for other devices. It appears that until the transition is complete no new devices can be introduced to Europe.

3. The MHRA has now introduced a database of all devices that can be sold legally in the UK. This database can be found at Public Access Database for Medical Device Registration (mhra.gov.uk)

4. There are two major changes that could impact the supply of medical devices in the UK. Presently all devices with a CE mark can sell also in the UK but at some time in the future a CA mark will become a legal requirement. At that time companies that predominantly sell in the EC and not in the UK may decide not to sell their products in the UK due to the additional cost. The second issue is that the new MDR technical file audit system has been more complicated to implement than planned as a result the implementation date has been moved from the end March 2024 to the end of 2028. During this period, it may be virtually impossible to introduce a new device onto the European market. In addition, many companies may decide the cost and the complexity of the MDR is not worth it and will take devices off the market.

 

If you would like to find out how our decontamination services can help you, please contact us.

Medical Device Regulatory System Update

Recent Articles

AP(D) Authorised Person Course – Glasgow

We are pleased to announce that our Authorised Person (Decontamination) Training Course (APD01) will be available between  14 to 17 May 2024 at NHS Greater Glasgow & Clyde.

This is a 4-day course to teach staff the skills and expertise needed to perform day-to-day tasks and duties to effectively manage aspects of decontamination.

read more

Quality Management Systems Course Showcased at IDSc

Cambridge University Hospitals-AVM attended the 17th Annual Institute of Decontamination Sciences (IDSc) conference on 28 and 29 November 2023 to showcase our newly-released online training course, Quality Management Systems 1 (QMS1). 

To ensure ease of use and broad-based accessibility, the course is video-based with interactive elements and is designed to be highly informative and beneficial to staff involved in the decontamination of reusable medical instruments such as surgical instruments or endoscopes.

read more

AVM Services – Decontamination Specialists

Professional training, consultancy and specialist services for decontamination testing and validation