On 26 June 2022, the United Kingdom’s Medical Devices and Healthcare Regulatory Authority (MHRA) published the results and conclusions from the consultation process regarding the new Medical Device Regulations for the UK. Originally initiated in September 2021, the final outcome, entitled “Consultation on the future regulation of medical devices in the United Kingdom,” may be found here.
This new document consists of 15 Chapters, each containing responses to the initial proposals, with the last section confirming a final response and conclusions from the UK government. In total, there were 891 individual responses to the initial proposals ranging from healthcare professionals, manufacturers, trade associations, healthcare institutions and patients/members of the public.
The final MHRA proposals contain comprehensive coverage of the various requirements to be included in the new UK Medical Device Regulations guidance. These new regulations are primarily based on EU Medical Device Regulation (MDR) 2017/745 requirements, but with significant differences in some key areas and new requirements surrounding new and innovative medical devices.
As presented, the new MHRA Medical Device Regulations will only relate to Great Britain (England, Scotland and Wales), as Northern Ireland is currently covered by the Northern Ireland protocol; in practice, this places Northern Ireland under the regulatory control of the EU. However, there are attempts to make changes to the protocol at this time so this area is likely to change in the near future.
Highlighted below are some of the significant areas of difference of the MHRA Medical Device Regulations in contrast to the MDR, as well as consideration of new areas related to innovation. Also addressed below are the transitional processes put in place to ensure that medical devices are still available on the UK market after the implementation date of the UKCA (1 July 2023). Note: In Vitro Diagnostic (IVD) products are covered in Chapter 9 of the new MHRA guidance; information on these devices will be highlighted in a future NAMSA blog post.
Significant Differences between the MDR and UKCA
- GMDN nomenclature will be used instead of EMDN and will be relevant for registration purposes.
- A Great Britain Medical Database is to be set up in the future, but is not presently in place; this database will be similar to the EUDAMED database, presently under construction.
- UK-approved bodies will be allowed to conduct off-site/hybrid audits in specifically defined and justified circumstances.
- Conformity Assessment – Type Examination (MDR: Annex X) and Product Quality Assurance (MDR: Annex XI Part B) will not be available under UKC
- The UKCA regulation will introduce new requirements on the entire equivalence on a biological, technical and clinical basis. The consultation document states “This approach would take us beyond the equivalence requirements in the EU MDR.”
- There will be no exemptions for clinical evidence requirements for implanted devices, such as screws and wedges, included in the UK regulations. This differs from the approach taken in the EU.
- No expert panel(s) processes will be implemented for high-risk devices and there are no specific requirements defined for Class IIb active devices intended to administer and/or remove a medicinal product.
- Software classification rules will be amended to include the IMDRF risk categorisation in the IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations with consequential implementing rules and definitions and clear guidance.
- Artificial Intelligence (AI) – There is no intention to introduce any AIaMD-specific requirements in the legislation.
- Requirements on Hospital Sterile Services Departments (SSDs) as re-manufacturers will be included in the regulations.
- There will be a prohibition on the re-manufacture of Class I single-use devices and the re-processing of single-use devices.
- Custom Made Devices (CMDs) – Manufacturers will be required to draw up a clinical evaluation report (CER) and keep information on how the relevant essential requirements have been met. PSUR’s for Class IIa, IIb & III CMD’s and PMS Reports for Class I CMD’s will be required.
Areas of Similarity with the MDR
The following areas have requirements which, if not exactly the same, are very similar to the requirements of the MDR. These include:
- Classification changes (e.g. spinal implants up-classified to Class III)
- ERs/GSPRs – There will be some additional domestic UK content (e.g. labelling requirements); however, a significant majority of the UK ERs will be the same as the GSPRs in the MDR (minor point: the UK regulations still refer to Essential Requirements and not GSPRs)
- Same Annex XVI devices covered with same proposals for devices without an intended medical purpose
- QMS – All manufacturers must have QMS, but presently not mandated to be ISO13485
- Obligations of Importers and Distributors
- Requirement for Approved Persons
- UDI requirements (e.g. require Basic UDI-DI), same 4 x issuers as MDR to be used
- Registration – All Economic Operators will receive a unique MHRA-generated number
- All Class IIb implantable devices will have 100% review of Technical Documentation (except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors – same exemptions as MDR)
- Introduction of the category of Class I reusable devices
- Document retention times changed to MDR requirements
- UKCA Certificates and DoCs to have similar information, per the MDR
- SSCP & PSURs, as per MDR, to be used
- PMS Plans and PMCF requirements similar to MDR
- Vigilance/Trend Reporting, basically the same as MDR, although definition for “serious incident” has been modified
- Implant Cards to be introduced with limited exemptions
New Requirements in UKCA Concerning Innovation and Routes to the UK Market
Both of these areas are covered by Chapter 14 of the proposals.
An innovative MedTech route to market will benefit patients, clinicians and manufacturers. In light of this, the UK government intends to proceed with the proposal to establish this route. A key feature of this process is that the MHRA will hold additional powers to grant initial market approvals.
The regulations will create a structured pathway for devices meeting the following criteria:
- Size of patient population – rare conditions/small patient groups
- Scale of innovation – devices that will be “game changers” for end users
- Size of manufacturer – targeting small and medium sized enterprises (SME#s)
The MHRA will set up hubs for innovation, by which they will support manufacturers’ research and data gathering activities, alleviating some of the cost and capacity obstacles faced by SMEs in getting innovative products to market. Under this proposed alternative pathway, the MHRA will grant approval for the manufacturer to make the device available on the market prior to obtaining a UKCA marking.
Following the pre-market approval phase, manufacturers using the alternative pathway would then be required to switch over to the mainstream Approved Body route for UKCA marking and post-market surveillance, etc. This would avoid potential ‘conflict of interest’ issues.
Routes to Market
The regulations propose to utilize both MDSAP certificates and Domestic Assurance as alternative routes to the UK market.
It is expected that UK-Approved Bodies will also be AOs under the MDSAP scheme and in most cases, this should be a seamless process. However, there will be some AOs who do not have an affiliation to a UK-Approved Body. In such cases, the manufacturer would need to appoint a UK-Approved Body to review outputs from the AOs MDSAP audit and device technical documentation prior to issuing their own UK certification.
Domestic Assurance – The MHRA will accept approvals from other international medical device regulators. Devices with approvals accepted by the MHRA may be subject to a domestic assurance process, in which UK-Approved Bodies could perform an abridged assessment of the device with appropriate levels of scrutiny. This is to ensure that a device meets the requirements of the UK regulations, and may also include an assessment of a manufacturer’s QMS. The MHRA will need to consider which regulatory approvals it could accept, and the appropriate level of domestic assurance required to accept the device onto the UK market.
Domestic assurance would not be relevant for clients of EU Notified Bodies who also have designation as a UK Approved Body. Such Clients could be offered a ‘CE plus UKCA’ route which would result in certification for both the UK and EU markets.
All manufacturers who utilize the MDSAP or Domestic Assurance approach must register with the MHRA and appoint a UK Responsible Person where they are based outside of the UK.
It should also be noted that UK-Approved Bodies will be required to have UKAS accreditation.
Perhaps the most immediate critical aspect for manufacturers relates to the transition periods that will be implemented:
Transitional arrangements for UKCA marked devices before July 2023: This transitional arrangement for medical devices will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years after the new regulations take effect, whichever is sooner.
Transitional arrangements devices that are CE marked under the EU Medical Devices Regulation (MDR 2017/745): This transitional arrangement for medical devices will allow, at a minimum, products to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner.
Transitional arrangements for devices with valid CE certificates issued under EU Medical Devices Directive (MDD 93/42/EEC & AIMD 90/385/EEC): This transitional arrangement for medical devices will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years after the new regulations take effect, whichever is sooner.
There are two (2) caveats will apply to all three (3) transitional arrangements, which are somewhat aligned with Article 120 of the EU MDR:
- Devices that are subject to significant changes in design or intended purpose will be excluded from these provisions; and
- All post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements
There are also transitional arrangements for Clinical Investigations conducted in the UK. This will apply to clinical investigations which commence under the existing regulations before the new regulations take effect on 1 July 2023, and which would not be completed before the new regulations take effect.
Clinical Investigations which commence under the existing regulations before 1 July 2023 may continue to be conducted from that date providing any additional reporting requirements laid out in the new regulations for clinical investigations that commence on or after 1 July 2023 are met (such as requirements for serious adverse events or device deficiencies).
The UK Government and the MHRA have produced a new set of regulations which are presently based on the requirements of the EU MDR 2017/745 with differences in specific areas with enhanced requirements (e.g. equivalence) and to take account of local requirements (e.g. labelling). However, for those manufacturers who also have CE certification, the changes are not as widespread as originally feared. There are also new and interesting proposals, particularly in relation to innovative products and SaMD, which may be built upon in the future.
It is also noted that a pragmatic and sensible approach has been taken in relation to transition periods using existing UKCA, MDR and MDD/AIMD certificates which will ensure that the UK does not hit a medical device “brick wall” on the 1 July 2023, when these regulations come into force.
The proposed regulations do reference further and/or new guidance which will be published moving forward, as such, it is strongly recommended that manufacturers monitor this situation as some areas are still at an overall proposal stage with more in-depth details to be published.
Link to the MHRA website for the full consultation document: Consultation on the future regulation of medical devices in the United Kingdom – GOV.UK (www.gov.uk).
Kevin Butcher is an experienced Senior Manager with extensive knowledge of medical device regulatory requirements, including Product Technical Files and QMS 3rd Party auditing. Mr. Butcher possesses 18 years of Notified Body experience, latterly as Certification Manager for SGS United Kingdom. Kevin joined the medical device consulting team at NAMSA in January 2021 and currently serves as a Principal Regulatory Consultant.