MDCG 2023-3 on Vigilance Terms & Concepts Revised: New Questions, More Examples, and IVDR Added
11 November 2024
New EU Commission Guidance Published: ‘Q&A on the Gradual Rollout of EUDAMED’
22 November 2024The announcement on the new public consultation is available: HERE
Below we outline each of the MHRA’s proposed regulatory amendments.
NOTE: the below only applies to Great Britain (England, Scotland, Wales). Northern Ireland, the fourth UK country, is part of the European single market and therefore requires CE Marking.
International Reliance
The International Reliance* framework proposes to:
- Allow certain** devices with marketing authorization in Australia, Canada, Europe, and the US, to have an abridged review process in the UK.
- The list of countries may be expanded over time.
- Be a supplement to UKCA Marking, which will remain available, i.e., companies can UKCA Mark, or if they qualify, they could obtain approval under the International Reliance route instead.
- Be an abridged review, i.e., the device will still have a review process prior to marketing.
- A UK Approved Body will complete the review. The review levels are (from lowest level of requirements to highest): Route 1, Route 2, Route 3, and Route 4
- An example of the information package for (some) US 510(k) devices: review of the post-market surveillance plan and post-market data from the last 5 years, review that Quality Management System (QMS) requirements have been met, and if applicable, that the implant card & patient leaflet meets requirements, and that the instructions for reusable devices contain an appropriate level of information on its reuse.
- See the table on page 12 of the proposal, for an overview of each route
- Require additional UK-specific requirements, e.g.,
- Be classified according to the UK’s classification rules
- English language labeling
- Implant card requirements
- Have a physical Unique Device Identifier (UDI) on parts and labels
- Comply with the new Post-Market Surveillance requirements
- Appoint a UK Responsible Person
- Register the device with the MHRA
- Class I devices must provide a “self-declaration for an appropriate Quality Management System (QMS)” during the registration
- Validity of the UK International Reliance certificate would be aligned with the regulatory approval market (e.g., EU CE Certificate) or QMS certificate (e.g., MDSAP, ISO 13485).
- Software as a medical device would initially only be eligible for the highest review route, which includes a review “that demonstrates there are no differences between the CRC [comparable regulator country] and GB [Great Britain] that adversely impact on the safety or efficacy of the device and the appropriateness of any pre-determined change control plans.”
*The terminology is aligned with definitions from the WHO. ‘Recognition’ is the acceptance of the regulatory decision of another regulator, considering it sufficient to meet the regulatory requirements. ‘Reliance’ is where the regulatory authority in one jurisdiction takes into account, and gives significant weight, to assessments performed by another regulatory authority when reaching its own (independent) decision.
**Certain devices mean those that have been through an equivalent, or near equivalent regulatory review process in Australia, Canada, Europe, or the US. For example, the following types of devices are not eligible for the International Reliance route:
- Software as a medical device that has gained access to the US market via the FDA 510(k) clearance process
- Devices that comply with US 510(k) legislation, which are Class IIb implantable (excluding the devices listed in Route 4) and Class III in Great Britain
- Devices granted market access in the comparable regulator countries (CRCs) via reliance routes, e.g., a device that went through abridged review in Australia, based on having leveraged the device’s original approval in Japan
- Devices that contain non-viable cells and tissues of human origin
- The following can only leverage EU CE Marking: medical devices that utilise animal tissues and their derivatives, medicinal products that include a medical device in the secondary packaging of the medicinal product (i.e. co-packaged), and companion diagnostics
NOTE: CE Marking is currently accepted in Great Britain until 2028-2030 (exact timing depends on the type of device). The above reliance framework is proposing CE Marking be recognized even after these dates. However, not at the same “face value” as it is today. Instead, after 2028-2030, CE Marked devices would fall under the International Reliance Framework.
UKCA Marking Symbol
The MHRA will implement Unique Device Identification (UDI) requirements, which are:
“a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It looks like a barcode and allows the unambiguous identification of a specific medical device on the market. The UDI is unique to the medical device itself, enabling us to identify the medical device and who manufactured it or placed it on the market.”
As UDI allows for improved traceability of devices, the MHRA proposes that manufacturers of UKCA Marked devices can stop adding the UKCA Marking symbol to the devices.
NOTE: the above does not mean that the UKCA Marking process itself is being removed. Instead, it proposes that if a manufacturer chooses to follow the UKCA Marking conformity assessment process, they can skip adding the UKCA symbol to the device, as the UDI would allow sufficient traceability.
IVD Regulatory Process
The MHRA intends to reclassify IVDs:
The proposal requests feedback on the conformity assessment level for each risk class (table below). Their aim is to make the safety controls proportionate to the risk level.
Specifically, as Class B devices have moderate individual risk and/or low public health risk, the MHRA proposes a “self-certification/declaration” that the device fulfilling the regulatory obligations + QMS certification could be sufficient. The exception is if the device is provided in a sterile condition. In this case, for both Class A and B IVDs, a conformity assessment related to the sterility aspects would be required.
Otherwise, the conformity assessment process for Class A, C, and D devices would “stay closely aligned with the EU”.
| Classification System | Risk level | Market Access | Specific Requirements |
|---|---|---|---|
| Class A* | Low Individual Risk and Low Public Health Risk | UKCA self-declaration of conformity | Self-declaration against the relevant Essential Requirements Ensure the device fulfils the applicable obligations described in IVDD Annex III |
| Class B* (incl. self-test devices not in a critical situation) | Moderate Individual Risk and/or Low Public health Risk | UKCA self-declaration of conformity + QMS certification | Self-declaration against the relevant Essential Requirements Ensure the device fulfils the applicable obligations described in IVDD Annex III QMS certification to ISO13485, issued by a certification body accredited by UKAS |
| Class C (incl. self-test) | High Individual Risk and/or Moderate Public Health Risk | UKCA conformity assessment by an Approved Body | IVDD Annex IV Audit of QMS or MDSAP Audit technical documentation (sample only) |
| Class D | High Individual Risk and High Public Health Risk | UKCA conformity assessment by an Approved Body | Design dossier review IVDD Annex IV Audit of QMS or MDSAP Batch released by approved body Common Specification requirements |
*If a Class A or B IVD device is required to be sterile then it will need to undergo a conformity assessment by an approved body only for sterility.
Removing Expiration for Some EU Legislation
The following EU legislation is referenced in the UK MDR 2002, which was transposed into UK law prior to ‘Brexit’. These are due to expire in Great Britain on 26 May 2025:
- Commission Decision 2002/364 on the common specifications for in vitro diagnostic medical devices
- Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
- Regulation (EU) No 722/2012 concerning particular requirements for medical devices manufactured utilizing tissues of animal origin
- Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies
The MHRA proposes to maintain the “regulatory status quo” by removing the revocation date for the above.
Consultation Period
Your feedback to the above proposals can be submitted: HERE
The consultation opened on 14 November 2024 and closes on 5 January 2025 (at 11:59pm).
