It’s been several months since the UK medical devices regulations transitioned from MMD to MDR – so what impact has this move had on the industry and what has it meant for job opportunities within the sector?
First, though we need to understand what exactly a medical device is and what regulations had been in place previously.
What are medical devices?
According to lifechanginginnovation.org a medical device can be classed as an “instrument, apparatus, implant, machine, tool, in vitro reagent, or similar article that is to diagnose, prevent, mitigate, treat or cure disease or other conditions”. Whereas pharmaceutical and biologic products work by chemical or metabolic actions within or on the body, a medical device is different in that it is used in physical or mechanical action.
Brexit and medical device regulations
Since January 1st 2021 and the UK’s exit from the EU, there have been a number of legislative changes made to how medical devices can trade within Great Britain’s market. (Things are different in N.I. but we’ll look at this later.) There are now a number of phases and deadlines that medical device manufacturers importing into Great Britain and Northern Ireland need to be aware of.
The EU MDR (European Union’s Medical Device Regulation) was originally meant to be implemented post-Brexit in May 2020, but the Covid-19 pandemic saw it postponed by a year.
It was brought in to replace the Medical Device Directive (MDD), with an aim of unifying the market and tightening up requirements. The new EU MDR is only applicable to EU member states. As the new regulations were not implemented during the Brexit transition period, the UK does not fall under these regulations.
What are the new regulations for the UK?
What are the new regulations and what do these mean for businesses looking to import their medical devices into Great Britain?
On the 26th May 2021, the UK’s medical device laws diverged from EU law in line with Brexit. This symbolised the end of the transition period from the MDD and saw the full application of the EU MDR across all EU member states. As a result, in May 2022 we’ll also see the EU in vitro Diagnostic Medical Devices Regulations (EU IVDR) fully applied across all EU member states. Neither of these regulations will be applicable to Great Britain.
The UK MDR (UK Medical Devices Regulations 2002) will continue to apply in England, Scotland and Wales. Not to be confused with the EU MDR, the UK MDR will continue to give directives to the EU AIMDD, EU MDD and EU IVDD, meaning the route to market in Great Britain and the UKCA marketing requirements will still be based on the requirements derived from current EU legislation.
If a medical device or in vitro diagnostic product already has a CE mark, this will continue to be recognised within Great Britain until 30th June 2023, but manufacturers must also:
- Appoint a UK Responsible Person, if based outside the UK, to act on their behalf.
- Register the product with the MHRA before the device’s classification deadline
- If a medical device was already registered with the MHRA before 1st January 2021 there is no requirement to re-register the device, but all information held by the MHRA must remain compliant.
- Start preparing for future regulatory requirements for UKCA marking (see below) planned for implementation from 1st July 2023.
It’s hoped that this new way of regulating medical devices within Great Britain will create a structure allowing for the UK Government to legislate for amendments to existing laws within the pharmaceutical industry quickly and decisively, whilst ensuring the UK continues to lead the way within the life sciences industry. The Government claims this will be “invaluable to the UK creating its own regulatory landscape”.
Future UKCA requirements
Up until the 1st July 2023, UKCA marking – a new certification mark that covers most goods that previously required the CE marking and indicates conformity with the applicable requirements for products sold within GB - is voluntary. However, manufacturers are being encouraged to start complying with the UKCA regulation requirements within plenty of time for the transition in 2023. Ahead of this date, it is expected there will be long lead times for any devices requiring review by a UK Approved Body.
What about Northern Ireland?
We mentioned earlier that the legislation in Northern Ireland is different to that in England, Scotland and Wales. This is a result of the agreements made around Northern Ireland and Brexit and will see the EU MDR and EU IVDR applied in Northern Ireland from the 26th May 2021 and 26th May 2022 respectively.
Although the rules differ, under the Northern Ireland Protocol there is still a requirement to register medical devices with the MHRA and if the manufacturer is based outside the UK, a UK Reasonable Person will also be required.
What impact have the new regulations had on the Regulatory jobs market?
Here at Carrot Recruitment, we’ve seen first-hand the positive impact the change in medical device legislation has had on the job market. We asked our specialist Regulatory Affairs consultant, Hayley Shayestehroo, to discuss further:
“Through the change in legislation, I’ve seen numerous extra roles being required by my clients, both of a permanent and temporary nature. Prior to the switch in legislation, companies were looking to hire people to help them “get ready” for the change, by ensuring technical files were all up to date in order to switch them over.
“Post-MDR there are still plenty of jobs available, particularly post-market/remediation type opportunities, whereby they keep all the technical files current and up to date with ever-changing legislation.”
If you’re looking for your next role within Regularly Affairs contact Hayley Shayestehroo today on:
01625 361072
Or take a look at our live Regulatory vacancies here.
