5 September 2023
The crisis in the regulation of medical devices in the EU and, as a consequence, the UK, continues. Manufacturers are being urged by regulators and notified bodies to make their notified body applications at the earliest opportunity.
At the same time, manufacturers must take the time to ensure that their technical documentation is correct and complete before submission. This is challenging for manufacturers in the EU's black box regulatory environment, where specific guidance for an individual device is not available from the regulators or notified bodies. As well as a mass of complex and sometimes contradictory guidance, there is a lack of consistency of application of the law and guidance by notified bodies and even within notified bodies. As time passes and experience is gained, a level of consistency is being aimed for through harmonisation efforts by Team NB.
In the current economic climate of soaring costs, companies requiring additional clinical data for their legacy devices are weighing up the value of those devices against the cost and uncertain timelines for notified body certification under the MDR. Time will tell whether the current lack of the anticipated number of applications for certification under MDR and IVDR is due to delay on the part of manufacturers, or manufacturers deciding not to continue to sell their devices under the EU's CE mark, or, more likely, a mix of both reasons. 24 May 2024 is the date by which manufacturers of legacy general medical devices must apply for an MDR conformity assessment with their MDR-compliant QMS. At that point, notified bodies will have the data to determine the number of legacy general medical devices requiring MDR certificates, and by extension will be able to calculate the number that are being removed from the EU market.
In the interim, time extensions have been granted in the EU and the UK. Even these have not been easy to follow, with additional conditions and a range of different timelines to be aware of according to the device. The EU Commission has issued an 11 page guidance on the transitional periods, though manufacturers should note that this is not 'formally endorsed'.
The UK has added an overlay of its own timings for ongoing recognition of the UKCA mark under 'old' regulations (new regulations still awaited) and of recognition of the EU's CE mark with new regulations, expanded upon with guidance. It remains to be seen what the long-term holds on recognition of the CE mark in the UK. In the interim, the timings for the UK and the EU for regulatory compliance for general medical devices and IVDs are summarised below (excluding non-CE-marked devices such as those for clinical trials) as well as guidance and advice from the EU and UK regulators.
|'Old' UK Law UKCA||N/A||3 years after new UK MDR effective (1 July 2028) (presumption from consultation response)|
|MDD/AIMD with NB certificate - III and IIb implantable (legacy devices)*+#||31/12/2027||Same as EU certificate++|
|MDD/AIMD other devices with NB certificate (other legacy devices)*||31/12/2028||Same as EU certificate BUT only until 30/06/2028 – 6 months earlier than potential EU cert expiry ++|
|MDD/AIMD no NB certificate**, but one required under EU MDR (up classified)||31/12/2028||DoC effective until 30/06/2028 – 6 months earlier than potential EU cert expiry ++|
|No NB certificate under directives or regulations (Class I not sterile or measuring function)||Must have MDR DoC by 26/05/2021 (no extension)||N/A (Must be UKCA compliant (to 30 June 2028 under 'old' UKCA, or MDR compliant and CE marked, until 30 June 2030))|
|EU MDR certified (not expired or withdrawn)||To cert date||30/06/2030|
|Custom made devices||As applicable above, or 26 May 2026 if implantable||N/A (Must be UKCA compliant (to 30 June 2028 under 'old' UKCA, or MDR compliant and CE marked, until 30 June 2030))|
Notes to the above table
* Any NB certificates under MDD/AIMD still valid on 26 May 2021 and not subsequently withdrawn, even if since expired
** Declaration of Conformity dated before 26 May 2021
+ See different provision for class III implantable custom-made devices below
# excluding sutures, tables, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
++ Some additional documentation requirements for custom-made devices and systems and procedure packs in the UK
The granting of the EU extension is conditional on either:
A competent authority granting an Article 59(1) or 97(1) derogation in respect of the device. Note though that with the availability of the extension, the granting of derogations has been limited by MDCG Guidance essentially to those granted derogations prior to 20 March 2023.
Furthermore, devices that are to be placed on the market or into service with the benefit of the extension must always:
No later than 26 September 2024 the notified body and the manufacturer must have signed a written agreement for the conformity assessment.
Class II custom-made implantable devices benefit from a certificate extension to 26 May 2026 if:
by 26 September 2024 the notified body and manufacturer have signed a written agreement in respect of that conformity assessment.
Surveillance for MDD/AIMD certified devices continues to be undertaken by the notified body that issued the certificates until 26 September 2024, unless the notified body undertaking MDR certification agrees in writing to take this responsibility over at an earlier date.
|'Old' UK Law UKCA||N/A||5 years after new UK MDR effective (1 July 2030) (from consultation response)|
|With an IVDD NB certificate issued under Annex VI IVDD, or after 25 May 2017, requiring IVDR certificate||27/05/2025||Same as EU certificate|
|With no IVDD NB certificate, but needing an IVDR NB certificate and with a declaration of conformity dating before 26 May 2022 (complies with Annex I IVDD or essential requirements in regulations 35(3) and (4) UK MDR 2002)||
Legacy declaration of conformity effective until:
Class D: 26/05/2025
Class C: 26/05/2026
Class B: 26/05/2027
Class A: (self-certified under IVDR) 26/05/2027
|Same as validity dates for EU CE marking under IVDD|
|No IVDD certificate and no IVDR certificate requirement (Class A, non-sterile)||Must have IVDR DoC by 26/05/2022 (no extension)||N/A for extension (Need to be UKCA compliant and marked (to 1 July 2030 under 'old' UK MDR), OR IVDR compliant and CE marked – until 30 June 2030)|
|IVDR certified||30 June 2030|