EU Commission Survey: Notified Body Update on MDR/IVDR Certifications & Applications
17 May 2024
MDCG 2022-4 Rev. 2: Updated due to extended MDR transition period & EUDAMED rollout
28 May 2024Today the MHRA published two updates:
Below we provide an overview of both topics.
International Recognition Framework
As previously reported, the MHRA is working on a policy to recognize marketing approvals granted by other ‘comparable’ regulator countries (CRCs). Please find below an overview of the draft policy.
Timing
The MHRA is still in the testing phase, and aims to bring this in force in 2025.
Eligibility
- This only applies to Great Britian* (England, Scotland, Wales)
- The initial list of comparable regulators are:
- Australian Therapeutic Goods Administration (TGA)
- Health Canada
- National Competent Authorities in the EU/European Economic Area (EEA)
- US Food and Drug Administration (FDA)
*Northern Ireland, the 4th UK country, has remained part of the European single market for medical devices post-Brexit. Therefore, Northern Ireland requires CE Marking and follows EU regulatory requirements.
UK Specific & Application Requirements
- Certain Great Britian requirements remain applicable, such as:
- English language labeling
- Electronic compatibility, units of measure, and labeling materials of concern (e.g., carcinogenic substances)
- Have a UK Responsible Person (UKRP) and add their name and address to the label
- UDI compliance
- Meet UK post-market surveillance requirements
- Must submit a dosser in the IMDRF Table of Contents format (or equivalent used in the comparable regulator’s market)
- The dossier will not be reviewed during the submission process, but the MHRA may review later as needed, e.g., due to post-market events
Post-approval
- Eligible devices would receive a “certificate of international recognition that will grant access to the Great Britain market”.
- This certificate does not constitute UKCA marking. The UKCA symbol should not be used unless the device is UKCA marked.
- Marketing authorization in Great Britian will only remain as long as the validity of pre-market approval in the comparable regulator country.
- If certain marketing approvals do not expire (e.g., US FDA 510(k)), then the validity will align elsewhere, e.g., the MDSAP certificate.
- Note that Class I non-sterile, non-measuring, non-reusable and Class A IVDs may self-declare their compliance with Australia, Canada, EU or USA legislation
Products Not Eligible
- Custom-made devices
- SaMDs that do not meet the MHRA’s intended purpose guidelines
- SaMDs approved via a route that relies on equivalence to a predicate device, e.g., US FDA 510(k)
- Products leveraging an approval that was based on a recognition route, e.g., trying to leverage an Australia marketing authorization in the UK, where that Australian authorization was granted based on leveraging a Japan Pre-market Approval
- Class IIb (non-well established technology (WET)) implantable and Class III devices that were approved via a route which relies on equivalence to a predicate, e.g., US FDA 510(k)
- Companion diagnostics (CDx) approved via a route which relies on equivalence to a predicate, e.g., US FDA 510(k)
- Companion diagnostics (CDx) and combination products containing medicinal substances that are not licensed in the UK
- Exempted in-house devices
- Products excluded from the scope of the UK MDR 2002, listed in Regulation 3, e.g., human blood products, products incorporating tissues of human origin
Additional Considerations
- UKCA Marking will remain as an eligible conformity assessment route for companies who do not have any plans to market outside of Great Britian
- Classifications mentioned reference Great Britian’s classification system, e.g., Class III device means, Class III under the UK MDR 2002
Early Access for Eligible Products?
The MHRA is considering granting “exceptional use of non-complying medical devices” for certain devices, that have marketing approvals in Australia, Canada, EU and USA.
The MHRA advised “if you would like to be considered for this”, please contact [email protected].
Need Help?
Whether you need a quote or just want to discuss the best options for your business, we will help guide you.
Consultation on IVD Common Specifications
The MHRA has opened a new consultation on common specification requirements for IVD devices.
If you would like to provide input, you must do so by midnight on Friday 14 June 2024.
Topics covered include proposal for:
- New measures for high-risk IVDs, such as blood tests used to identify blood type before transfusion, or to identify life-threatening diseases
- Removal of the Coronavirus Test Device Approval (CTDA) process, as it would be duplicate regulatory requirements if the above measures are implemented
The MHRA aims to incorporate IVD common specifications within the draft “future core medical device regulations”. These are expected to be published later in 2024, and come into force in 2025.
How to Submit Feedback
Below are the relevant links:
Further Reading
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