Director, Strategic Consulting, Medical Device & Diagnostic Research, ICON plc
As the UK’s transition period to leave the European Union (EU) rapidly comes to an end, the Medicines and Healthcare products Regulatory Agency (MHRA) recently published new guidance on how it will regulate medical devices starting in January 2021.
Through this guidance document, the MHRA — which will take over the responsibilities for the UK medical devices market currently undertaken through the EU system — sheds light on how the new UKCA (UK Conformity Assessed) system will operate, including device certification, conformity marking and device registration. The guidance also provides an overview on the different rules that will apply in Great Britain (England, Wales and Scotland), Northern Ireland and the EU.
The proposals outlined in the guidance notice will take effect through legislative changes that will be introduced later in 2020. They are still therefore subject to parliamentary approval.
The UK views this guidance as an opportunity to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety. It also is taking into consideration international standards and global harmonisation in the development of its future system. Over the next few months, the UK plans to engage with stakeholders within the life sciences and healthcare industries on identifying and prioritising elements of international practice that promote public health and patient safety. Following these meetings, the MHRA will conduct a formal public consultation.
In this blog, we outline the necessary details on these new rules.
Requirements for manufacturing and supplying devices in the UK
Starting from 1st January 2021, the roles and responsibilities of medical device and in vitro diagnostic device (IVD) manufacturers will change. The devices certified under the following Directives/Regulations will in due course, need to conform to the new legislation to stay on the UK market:
- EU Directive 90/385/EEC on active implantable medical devices (AIMDD)
- EU Directive 93/42/EEC on medical devices (MDD)
- EU Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)
- EU Regulation 2017/745 on medical devices (MDR)
- EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR)
Manufacturers wanting to place medical devices and in vitro diagnostic medical devices (IVDs) on the UK market will first need to register with the MHRA. Here, the agency’s role will be to perform market surveillance of medical devices on the UK market. Additionally, it will be responsible for the designation and monitoring of UK Conformity Assessment Bodies (CABs), which will assess whether products meet the UK Conformity Assessed (UKCA) mark requirements. Existing UK Notified Bodies with designations under the MDD, IVDD or AIMDD will have their designations rolled over automatically, without having to undergo a new designation process.
While CE marking will continue to be used and recognised until 30 June 2023, after this date, companies will need a UKCA mark to sell devices in Great Britain. The grace period for registering includes:
- Four months for Class IIIs and Class IIb implantables, and all active implantable medical devices
- Eight months for other Class IIb and all Class IIa devices
- 12 months for Class I devices (this grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA)
The new labelling requirements for UKCA marking will become mandatory from 1st July 2023. Manufacturers based outside the UK will need to establish a UK Responsible Person who will take responsibility for the product.
The UKCA marking alone cannot be used for goods placed on the Northern Ireland market, which require the CE marking or UK (NI) marking.
Post-market surveillance and vigilance
After a medical device has been placed on the UK market, the manufacturer is required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involve the device. In addition, the manufacturer will need to take appropriate safety action when required, ensuring the device meets appropriate standards of safety and performance for as long as it is in use.
Impact to MDR and IVDR
Products sold in Northern Ireland and the EU, where the incoming MDR and IVDR will apply, will still need to carry CE marks after June 2023. UKCA marks can accompany the CE mark on products sold in Northern Ireland, but not on devices placed on the EU market.
What manufacturers should do now
Companies should consider a regulatory partner before making preparations not only to ensure proper documentation, but also to determine which regulatory framework applies best to their product portfolios. While manufacturers have more than two years to gain UKCA marks, the grace period for transition to the mandatory UKCA marking requirements ends less than one year before the end of the MDR transition on 26th May 2024. For already registered devices and IVDs it is even shorter with only 4 to 12 months — depending on the risk class of the product — to comply with MHRA’s requirements, manufacturers should begin planning now.