Jul 1, 2022

Over the past months, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened a consultation on the current UK Medical Devices Regulations 2002. For those familiar with the UK MDR 2002, it is very similar to the old EU directives. Thus for medical device manufacturers less familiar with the UK MDR 2002, the current regulation is equivalent to the European Union’s Medical Devices Directive (MDD 93/42/EEC) and In-vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC). So market entrance in the UK would require you to pull up your old MDD or IVDD Technical File again.

Having this said, it is obvious changes to the UK’s medical device and IVD regulatory process are needed, just as changes were needed to the EU regulatory system. According to the MHRA, the UK MDR 2002 needs revision in order to ensure the UK becomes “the best place to develop and introduce innovative medical devices“ and to “support business through access routes that build on synergies with both EU and wider global standards.” The three other pillars (of the five pillars the UK followed) are: 

  • Strengthening MHRA power to act to keep patients safe (traceability/PMS/Vigilance reporting);
  • Addressing health inequalities and mitigating biases throughout medical device product lifecycles;
  • Setting world-leading standards – Building the UKCA mark as a global exemplar.

Key changes – alignment with the EU MDR

With the aim of developing future legislation for medical devices which delivers improved patient and public safety; greater transparency of regulatory decision-making medical device information; close alignment with international best practice; and more flexible, responsive and, proportionate regulation of medical devices, the following changes are expected:

  • Reclassification of medical devices, aligned with the EU Medical Devices Regulation (MDR).
  • Devices without a medical intended purpose, equivalent to EU MDR Annex XVI devices, will be regulated by the future UK MDR.
  •  Strengthening and increasing post-market surveillance (PMS) requirements ensure better incident monitoring reporting and surveillance. The new PMS and vigilance requirements are aligned with the EU MDR (same timelines, periodic safety update reports (PSURs) required as well as cooperation requirements for Economic Operators (EOs)).
  • Improved traceability of medical devices  via introducing Unique Device Identification (UDI) and registering of devices. UDI issuing entities are the same as those in the EU.
  • New conformity assessment routes, similar to the EU MDR. Including scrutiny for certain high-risk classes and implantable devices.
  • Stricter requirements related to Clinical Investigations and Performance Evaluation studies,  including requirements for sponsors and investigators. These requirements are all in alignment with the EU MDR and In Vitro Diagnostic Medical Devices Regulation (IVDR).
  • Requirement of registration of EOs and Sponsors/Investigators in the UK registration database. The MHRA will issue a unique number to each registration for each role. Note that in opposition to the EU, distributors are expected to be required to register in the UK as well.
  • Stricter oversight on UK Conformity Assessment Bodies (UK CABs) and more transparency into their activities, fees and regulatory decision-making (section 5).
  • Definitions of “intended use,” the scope of the UK MDR (products excluded from the UK MDR – section 3, 4), ”in-house manufacturing,” “health care institutes” and more.
  • Requirement for manufacturers and UK Responsible Persons (UKRPs) to have a Qualified Person (similar to the EU MDR/ IVDR Person Responsible for Regulatory Compliance).
  • Liability requirements for the manufacturer and UKRP are aligned with the EU MDR and IVDR.
  • Requirement for certain high-risk class and implantable devices to provide a Summary of Safety and Clinical Performance (SSCP) which Is made publicly available.
  • UK MDR’s Essential requirements will be aligned with the EU MDR General Safety and Performance Requirements (GSPRs).
  • Claims will require supportive (clinical) data, see Article 7 EU MDR.

And more… essentially there is alignment with the EU Regulations (again).

So what will be different from the EU MDR?

  • Possible pre-approval route for innovative devices such as software as a medical device (SaMD) or devices using artificial intelligence or machine learning (AI/ML).
  • Alternative conformity assessment routes including domestic assurance to enhance the supply of devices and avoid shortages.
  • EOs are required to inform the MHRA in the event of shortages foreseen in the supply of devices which could affect the continuance of healthcare.

Although separate from this regulation, the MHRA announced to start of a work program for the regulation (wider guidance, policy, and standards) of health-related software and AI.

And what about IVDs?

IVD medical devices will now be classified from Class A (low risk) to Class D (high risk) and seven classification rules will be introduced; however, rather than aligning to the EU IVDR, the UK classification rules will more closely align with the structure used by the International Medical Device Regulators Forum (IMDRF), meaning that different classifications may apply in different jurisdictions. In addition, the MHRA plans to introduce classification rules specifically for companion diagnostic devices, and will consider the approaches taken by both the EU and IMDRF. The MHRA intends to proceed with a risk-based approach to the clinical evidence requirements relating to companion diagnostics, and this risk-based approach will also be reflected in the classification rules. Lastly, further consideration will be given to whether or not providers of testing services who supply IVDs to the UK market, either through electronic or other distance sales methods, will be subject to the same requirements of the UK medical device regulations that apply to EOs in the traditional supply chain.

When will this all happen?

No worries! First the UK MDR needs to be revised and approved. And the MHRA has announced to adopt “soft transition provisions” for "legacy devices" similar to the MDR and IVDR. Although the MHRA still plans for the new regulations to come into force in 2023, there are significant measures enabling products that already have conformity markings, either UKCA or CE, to remain on the market after the regulations come into force for a period of three to five years, depending on the device and the rules under which the existing conformity mark was given.

Annette Van Raamsdonk is Senior Regulatory Affairs Consultant and Karen Hill is Manager, Quality and Regulatory Affairs Program at Emergo by UL.

Additional UK medical device regulatory resources from Emergo by UL:

  • UK Responsible Person (UKRP) and Brexit transition consulting for medical device companies
  • Process Chart: UK regulatory pathway for medical devices

Author

  • Annette Van Raamsdonk and Karen Hill

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