On 9th June 2023, the UK government published a statutory instrument amending the UK Medical Device Regulation (2002). This publication was released after public consultation and has been approved by each UK House of Parliament.
As you know, post Brexit, the UK and the EU are undergoing regulatory reforms with high uncertainty and confusion. The EU is speeding the full implementation of the EU Medical Device Regulation [MDR 2017/745 ] and In-Vitro Diagnostic Regulations [EU IVDR 2017/746], which have gone through a series of extensions and amendments in the timelines. These extensions and amendments are keeping manufacturers on their toes as they need to create a dynamic strategy that can support medical devices in real time. Amidst all these developments, medical device manufacturers must be reminded that the new amendments published on 9th June 2023 apply to Great Britain [ England, Scotland and Wales ]. Northern Ireland continues to follow EU Regulatory requirements with an obligation for manufacturers to adopt certain provisions of the UK MDR 2002 (as amended).’
On 9th December 2022, the European Commission proposed amendments related to EU Regulation 2017/745 – Medical Device Regulation [MDR] and Regulation 2017/746 – In-Vitro Diagnostics Regulation [IVDR]. Following the publication on 15th March, the proposal has now become law and has been published in the Official Journal of the European Union [OJEU].
In order to avoid MedTech supply chain disruption, several regulators amended their timelines to adapt and match REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending the transitional provisions for certain medical devices and in vitro diagnostic medical devices. The UK government took similar measures and published a new statutory instrument.
What does the recent publication from the UK look like?
Manufacturers and industry members enthusiastically welcomed this amendment as it gave them time to loosen their belts. While the industry rejoices, Regulatory Professionals are warning manufacturers to utilise this time and fasten their grips to achieve the right regulatory certifications before the DOOMS Day [The day when these extensions will hang as a deadline, resulting in products going ‘off the shelves’].
Important notes from the publication:
- These Regulations amend the Medical Devices Regulations 2002 to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain.
- The new regulation 1ZA sets out different dates ranging from 30th June 2023 to 30th June 2030. The effect of these new dates is that the period for placing devices on the market in Great Britain under regulations 19B and 30A (except custom-made devices), and 19C, 44ZA and 44ZB is extended.
- The manufacturer must ensure the certificate of conformity for the relevant device is valid before placing the device on the market.
- The amendments to regulations 19B, 30A and 44ZA provide that certificates issued under Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC that remain valid by virtue of the transitional provisions in Regulation (EU) 2017/745 or Regulation (EU) 2017/746, are considered valid for placing devices on the market in accordance with regulations 19B, 30A and 44ZA.
- Details of the extension can be seen in the image below.
Irrespective of these amendments, manufacturers need to
- Manufacturers of Class I devices that do not require notified body involvement under the EU MDD or the EU MDR must act now to ensure compliance with either the EU MDR or UK MDR 2002 prior to placing devices on the UK market.
- Make sure your Quality Management Systems are in Place.
- Ensure appropriate Transition plan from EU Medical Device Directives [EU MDD] to EU Medical Device Regulation in accordance with UK Medical Device Regulation are in Place.
- Contact Experts at Med-Di-Dia who can support you with completing your transition plans, technical files and documents.
- If you are yet to launch your medical device on the EU or UK Market, speak to our experts, who can create a comprehensive Regulatory Roadmap for a smooth launch.
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