The impact of the MDR amendment for manufacturers is that they can keep legacy medical devices on the European Union (EU) market until end-2027 or end-2028. During this time, they can manufacture the legacy device, place it on the EU market or export it to non-EU markets. It is important to understand what conditions are to be met and how to communicate about them.
The amount of transition time legacy devices can benefit from is staggered. Providing certain conditions are met, the MDR amendment extends the validity of legacy device certificates under the Medical Devices Directives (AIMDD/MDD) until the end of 2027 or 2028, depending on the MDR risk class of the legacy devices that certificate covers. It’s important to know that any legacy device – even if it won’t be transitioned to the MDR – can benefit from additional transition time until 26 May 2024, as long as it has a certificate that is valid up until that date or its validity is extended as described below.
Extension conditions
Providing certain conditions are met, the MDR amendment extends the validity of legacy device certificates under the Medical Devices Directives. Firstly, the certificate must have been valid on 26 May 2021 and should not have been withdrawn by its notified body. If the certificate would normally expire after 20 March 2023, then its validity is extended automatically by the MDR amendment until either end-2027 or end-2028.
For certificates that normally expired before 20 March 2023, validity is only extended either if a contract for MDR certification was signed between the manufacturer and notified body before the certificate’s normal date of expiry, or if the National Competent Authority granted a derogation under Article 59 or Article 97 of the MDR before 20 March 2023.
If a competent authority has granted a derogation in accordance with Article 59 MDR or has applied Article 97 MDR they shall be considered valid in two scenarios: If the manufacturer has signed a written agreement with the notified body for a conformity assessment of the legacy device; or if a national competent authority has granted a derogation in accordance with Article 59(1) MDR or has required the manufacturer, in accordance with Article 97(1) MDR, to carry out the applicable conformity assessment procedure within a specified period of time (see the second subparagraph of Article 120(2) MDR).
Even if the national derogation is limited in time or the manufacturer has been required to carry out the conformity assessment procedure within a given period of time, the legacy device can still benefit from the extended transition periods and the certificate is deemed to be valid until the end of the applicable transitional period unless it is withdrawn. If none of these conditions are met, the legacy device certificate cannot benefit from an extended validity according to the MDR amendment. In that case, CE-marking under the MDR should be considered.
There is also a specific transitional period for Class III custom-made implantable devices. While all other custom-made devices can be placed on the market after their manufacturer has drawn up a statement in accordance with Annex XIII to the MDR, the conformity assessment of Class III custom-made implantable devices requires the involvement of a notified body. These devices can be placed on the market without the relevant certificate until 26 May 2026, provided the manufacturer has lodged an application with a notified body for conformity assessment no later than 26 May 2024 and signed a written agreement with that notified body no later than 26 September 2024.
Cumulative conditions
There are a set of cumulative conditions that must be met for legacy devices to access and remain under the extended transition periods from May 2024 until the end of 2027 or 2028. Perhaps the most time-urgent one – since this deadline arrives in just eight months’ time – is that by 26 May 2024 at the latest, manufacturers must send a formal application to a notified body designated under the MDR to conduct a conformity assessment for the legacy device, or its substitute device (if applicable). By that date, the manufacturer must also have their quality management system in place in accordance with the MDR. By 26 September 2024, a contract for the device must be signed between the manufacturer and the notified body (including transfer of surveillance to the MDR notified body, where needed).
There are additional requirements for the device itself, including that it must comply with the relevant medical devices directive, it cannot have significant changes to its design and intended purpose, it cannot pose an unacceptable risk to the health or safety of patients and it must comply with relevant MDR requirements relating to market surveillance, postmarket surveillance, vigilance and registration of actors and devices.
It is important to know that when sending an application before the May 2024 deadline, the full technical documentation does not need to be submitted – it will need to be submitted according to the actual review start time agreed with the MDR notified body. This helps ensure that the notified body is reviewing the latest technical documentation. However, all the relevant documentation relating to the quality management system will need to be submitted when applying for the EU quality management system certificate. Manufacturers should consider communicating with their MDR notified body to understand what is required.
Communication is everything
If all of the above conditions have been met – congratulations. This is not the end of the challenge though – there is still the question of how to communicate to authorities, payers and customers inside or outside of the European Union that the legacy device product can legitimately benefit from the extended transition time. This can be a challenge, especially since the date on the certificate will show it as being expired, even if that certificate validity has been extended by the MDR amendment.
Manufacturers can issue a manufacturer declaration to declare the compliance of their devices and their own organisation with the conditions for the continued marketing of the device. The manufacturer declaration is specific to the MDR amendment and should not be confused with the EC declaration of conformity, which is an entirely different document. A template is available on the European Commission’s website to assist with this process. While many jurisdictions in and outside of the EU seem to be accepting the manufacturer declaration template, manufacturers and supply chain actors should always be on the lookout for differences – although it is to be hoped that the template available on the European Commission’s website will suffice. For example, the UK has issued their own template to be completed to show compliance with the MDR amendment. For the marketing of legacy devices outside of the EU, a certificate of free sale can also be obtained.
There is some confusion over when a letter from the MDR notified body should be sent to authorities, payers and customers inside or outside of the EU. Some authorities may request to see a letter from the MDR notified body as soon as possible. Here, it is important to know that the letter from the notified body confirming a contract under the MDR can only be issued after that contract has been signed. Since the manufacturer and notified body have until September 2024 to sign the contract, it is possible that some notified body confirmation letters will only be available in September or October 2024. Naturally, if a contract is signed at an earlier date (as many contracts already are) then the notified body may issue a confirmation letter at that point. Finally, in principle the notified body letter of confirmation should only need to be issued once. After all, the conditions (signing of the contract covering the applications which have been submitted) are only met once.
