Making sense of timelines and certificate extensions for placing medical devices on UK and EU markets

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.

Guide to timelines for obtaining notified body certificates/continued UK recognition for general medical devices

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 

Conditions for EU certificate extension for general medical devices

The granting of the EU extension is conditional on either:

• Before the certificate expired, the manufacturer and a notified body having signed a written agreement with a notified body for the conformity assessment under the MDR for the legacy device or a substitute device, or 

• 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:

• Be compliant with MDD/AIMD, as applicable (manufacturers should note that for those devices benefitting from the extension, MDR PMS and certain other requirements have been in force since 26 May 2021).

• Have no significant changes in design or intended purpose.

• Not present an unacceptable risk to the health or safety or patients, users or other persons or to other aspects of the protection of public health.

• By 26 May 2024 the manufacturer must have a QMS compliant with the MDR in place (proven by having the correct QMS documentation in place and as part of its MDR conformity assessment submission), and applied to a notified body for a conformity assessment with the information required in Annex IX (QMS), Annex X (for a type-examination) and Annex XI (Product conformity), as applicable. This does not require a full review of the application by the notified body or submission of technical documentation but must identify the manufacturer and the devices and a timeline for submission of technical documentation and other information, and

• 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 under EU extension provisions

Class II custom-made implantable devices benefit from a certificate extension to 26 May 2026 if:

• by 26 May 2024 the formal application has been made with a notified body for a conformity assessment.

• by 26 September 2024 the notified body and manufacturer have signed a written agreement in respect of that conformity assessment.

Other noteworthy points on MDD/ AIMD timings

• MDD/AIMD certificates and MDR certificates can be valid in parallel, permitting a gradual switch to manufacturing MDR compliantly labelled devices, if time allows.

• When considering which rules apply to devices up-classified under the MDR but still being placed on the market under their MDD/AIMD certificate(s), the MDD/AIMD requirements will apply (eg PSUR), except where the MDR requirements are mandatory, such as PMS requirements.

• For manufacturers needing to prove that they have a validly extended certificate (for procurement processes and other countries), there is a harmonised template developed by the industry for a self-declaration.

• Notified bodies can also issue a confirmation letter, for which Team NB has provided a template.

• Although there is a hard deadline for an agreement with a notified body for the MDR conformity assessment of 26 September 2024, manufacturers will be able after this date to switch notified body if they simultaneously with termination of the agreement with the first notified body, enter into an agreement with another notified body for EU MDR conformity assessment.

• Legacy devices do not have to comply with UDI requirements while their certificates issued under the directives remain valid and they are manufactured under them.

• 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.

Guide to timelines for in vitro diagnostic devices in the EU and the UK