A New Era for Medical Device Legislation in the UK

January 1st of 2021 marked a new era for medical device legislation in the UK. Leaving the EU single market means that to maintain compliance in the UK, you must now abide by the UK Medicines and Healthcare products Regulatory Agency (MHRA) guidelines. The new regulations affect a variety of product types from basic devices and drugs to machinery and electrical equipment. Manufacturers must be prepared to make significant changes to their regulatory processes.

Manufacturers and Economic Operators must be keenly aware of these changes if they wish to continue selling their products in the UK. Any CE marked product being sold in the UK and anyone in the supply chain for these products may be impacted due to the regulatory changes for required CE marking in the UK. The regulations that have required CE marking will change in the UK. Additionally, there will be differing regulatory models for Great Britain (England, Scotland and Wales) than for Northern Ireland.

You can read Celegence’s comprehensive White Paper titled The Burden of Brexit on the Medtech Industry to learn more.

The agreement applies to the following medicinal products for human and veterinary use:

• Marketed medicinal products for human or veterinary use, including marketed biological and immunological products for human and veterinary use
• Advanced therapy medicinal products
• Active pharmaceutical ingredients for human or veterinary use
• Investigational medicinal products

Staying in Compliance: Medical Devices Regulations (MDR) 2002 and under the UK Statutory Instruments 2002 No. 618 as amended (full section can be found in Celegence’s Brexit White Paper).

The MHRA has published a guidance document on the regulation of medical devices from January 1st 2021 (the “Guidance”). The guidance outlining the regulatory requirements that apply to medical devices after the Brexit transitional period under the EU-UK Withdrawal Agreement includes:

• From January 1st 2021, different rules apply to medical devices placed on the market in Great Britain (e., England, Wales and Scotland) and those placed on the market in Northern Ireland and elsewhere in the EEA.
• Manufacturers may continue to use the CE-mark, and it is recognised in Great Britain until June 30th 2023.
• Manufactures may continue to rely on EEA Notified Body certificates until June 30th 2023 for products placed on the market in Great Britain.
• There is a new route for conformity assessments of medical devices placed on the market in Great Britain from January 1st 2021.
• All medical devices and in vitro diagnostic medical devices (“IVDs”) placed on the market in the UK have to be registered with the MHRA. There are grace periods for registering existing devices depending on the manufacturer’s and authorized representatives’ status.

Manufacturers based outside the UK need to appoint a UK Responsible Person.

From January 1st 2021, regulatory labelling requirements mean that devices placed on the market in Great Britain will need to bear either the UKCA mark or the CE mark, as well as the number of the EEA Notified Body or UK Approved Body. Additionally, it should be kept in mind that products that bear the CE mark and the EEA Notified Body number do not have to be relabelled until July 1st 2023.

From a technical standpoint, the MHRA’s requirements will still be in line with the EU’s MDD. The plan is to amend these regulations in 2023 and the MHRA is already in the process of drafting these changes. The MHRA is using this period as an opportunity to avoid any pitfalls that present themselves in the EU with the MDR. This plan, in theory, should lead to a more efficient implementation process come 2023. However, it is still crucial that manufacturers stay up to date with any announcements from the MHRA leading up to their 2023 amendments.

Regulatory Labelling Changes
While the UK regulation accepts CE marked products with the EEA Notified Body number until July 1st 2023, you must be prepared to re-label after that date. The device industry is still waiting on the guidance from the EU as to when the cut-off date will be for accepting CE marked products from the UK and any necessary requirements for re-labelling. This is certainly an aspect manufacturers will want to keep an eye on moving forward.

Authorized Representatives
Device manufacturers based outside of the EU can no longer rely on a Great Britain based Authorized Representatives (AR) for their devices to be placed on the EU market. They must now appoint an Authorized Representative in the EEA. The Great Britain AR will no longer be recognized in the EU, which officially went into effect on January 1st 2021 regardless of when the products were originally placed on the market.

While the UK has split from the EU, the MHRA is now going to be the sole regulator for the UK market, with the UK still being focused on patient safety and device performance. The appointing of a UK Responsible Person will be vital for maintaining UK compliance for manufacturers based outside of the EU.  With Celegence’s presence in the UK (London), Celegence can support all of your Pharmaceutical, In Vitro Diagnostic and Medical Device regulatory needs. Additionally, if your organization is looking to maintain your market presence in the UK without a local office, we can act as your UK Responsible Person.

Regulations are ever-changing and while the MHRA is finalizing/drafting the UK Medical Device Regulations, it is prudent to keep yourself up to date with any updates from the MHRA that could add extra responsibilities to manufacturers outside of the EU.