Introduction and Background #
In early December 2022, a proposal was put forward to amend, amongst some other elements, the transitional provisions and compliance deadlines for legacy devices within Regulation (EU) 2017/745 on medical devices (MDR). A formal proposal was published by the EU Commission in early January 2023 and was accepted without any further amendments later that month by the Council of the European Union.
The procedure for proposal and acceptance can be seen here.
Although the EU MDR has been applicable since 26 May 2021, manufacturers have struggled to transition to this new regulation for various reasons. Therefore, in an effort to mitigate supply shortages, the Commission put forward this proposal with some key amendments which will be welcomed by many in the industry.
The proposed amendment can be accessed here.
NOTE: We have an updated article here.
What do the proposed amendments say? #
The key amendments being proposed revolve around an extension to the validity period of MDD and AIMDD certificates and the transition period to the EU MDR.
Provision I: Legacy Certificate Extensions #
Article 120(2) of the EU MDR shall be amended such that certificates issued for products with respect to the EU Medical Device Directive [93/42/EEC] and Active Implantable Medical Device Directive [90/385/EEC] will continue to be valid, if the following conditions have been met:
- The Directive Certificate was valid prior to 26 May 2021; and
- The Directive Certificate has not been withdrawn by the Notified Body.
This provision allows certificates meeting the above conditions to automatically remain valid, without the need for the Notified Body to re-issue with a new date. The length of the extension will depend on the proposed amendment of Article 120(3) which introduces a stepped approach as shown in Provision II below.
Expired Certificate #
In the event the Directive Certificate has expired, the validity of the certificate may be extended given that one of the below has taken place:
- The manufacturer has signed a contract for an EU MDR assessment with a Notified Body prior to or at the moment of certificate expiration; or
- A national competent authority:
- Has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59; or
- Requires the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97.
Provision II: Transition Period Extension #
Article 120(3) is arguably the most important paragraph of the EU MDR, especially since it allows for the concept of a “legacy device’. The proposal will see Article 120(3) split into several paragraphs from 3a to 3g to take into account different transitional timelines depending on risk classification. The transition period shall be extended from 26 May 2024 to:
- 31 December 2027: Class III and Class IIb implantable (not Well Established Technology – See MDCG 2020-06).
- 31 December 2028: Other Devices (Class IIb, Class IIa, Class Im/s/r).
Note: Those devices which did not require the involvement of a Notified Body under the MDD and which will now require involvement under the Regulation must have had a declaration of conformity drawn up prior to 26 May 2021 to benefit from this extension.
Terms and Conditions #
As with all good things in life, there are some T&Cs to take note of. Under the proposed extension, the following must be honoured:
- Devices must continue to comply with EU MDD and AIMDD requirements.
- There can be no significant change in design and intended purpose.
- The device shall not present an unacceptable risk to patients and other stakeholders.
- Manufacturers must have an MDR-compliant QMS by 26 May 2024.
- Manufacturers must have submitted a formal MDR assessment application by 26 May 2024.
1. Legacy Device Requirements #
Not much has changed here. Under the proposed extension, eligible legacy devices must continue to meet the requirements of the EU MDD and AIMDD. However, the manufacturer shall keep in mind that specific requirements of the EU MDR will apply, including:
- Post-market surveillance.
- Market surveillance.
- Vigilance specifications.
- Registration of economic operators and devices.
2. Design and Intended Purpose #
Similar to how Article 120 is already worded, whilst maintaining a legacy device, there shall be no significant changes made to its design or intended purpose. MDCG 2020-3 discusses at length what is meant by “significant”, and we anticipate this to continue to apply in this scenario too.
If you do make any changes, provide a rationale (when possible) as to why this cannot be considered to be a significant change. We would suggest discussing this with your Notified Body and keep any records of such decisions available for any requesting Competent Authorities.
3. Unacceptable Risk #
The device, or device type, shall not present an unacceptable risk to the health and safety of patients, users, other persons, or other aspects of the protection of public health, a concept originally laid out in Articles 94 and 95 of the EU MDR.
Since the device is already under appropriate surveillance by the Notified Body who has issued the certificate, this provision does not require a systematic check of the device’s safety. However, it warns that if a competent authority becomes aware that the device presents such an unacceptable risk, the transition period for that device shall end.
4. MDR-Compliant QMS #
The proposed extension requires that all manufacturers benefiting from the additional timeframe comply with the EU MDR’s requirements for the quality management system. These requirements are largely indicated within Article 10(9), however, there are additional requirements and obligations strewn around the MDR, especially within Annex IX, X, and XI.
A good approach would be to conduct a gap assessment against these requirements and put together a plan to address them. An excellent resource that should be part of your toolbelt is the EN ISO 13485:2016 + A11:2021. Annex ZA provides a discussion on the gaps between ISO 13485:2016 and the EU MDR.
Demonstration that this has taken place prior to 26 May 2024 should be in place. For ease of reference, legacy device manufacturers should have in place a document that clearly indicates which processes have been updated and when. Cross-linking these new processes to the requirements of the MDR will make it clearer for assessors to understand the efforts made to comply with the QMS requirements.
5. MDR Assessment Application #
In order to be eligible for the extended timeframe, manufacturers must lodge an application for MDR assessment with their Notified Body prior to 26 May 2024. This will need to be a formal application with that body, rather than just a few emails showing your intention. The Notified Body shall, by 26 September 2024, provide you with a signed written agreement.
In the meantime, the Notified Body that has issued the Directive Certificate will be responsible for surveillance of the device in relation to its requirements under the Directive. If agreed, this surveillance responsibility may also be taken up by the regulation-designated Notified Body referred to in the previous paragraph. Nevertheless, this Notified Body shall, by 26 September 2024 take on the responsibility for surveillance of the Directive-compliant device.
In some cases, the manufacturer may take the opportunity to replace a Directive-compliant device with a Regulation-compliant substitute. Even in such cases, the Notified Body with whom the manufacturer has entered an agreement with for MDR assessment shall take over the responsibility for surveillance of the legacy device. It is proposed that a threeway agreement is drawn up between the manufacturer, the “Directive Notified Body”, and “Regulation Notified Body” (to avoid more complicated words).
Your To-Do List #
If your product is eligible for the transition extension, we’ve prepared a small “To-Do” list to keep you on track:
- Meet all EU MDR post-market surveillance requirements.
- Update vigilance procedure to align with EU MDR.
- Register manufacturer and legacy device on Eudamed.
- Continue to meet MDD/AIMDD requirements without significant changes in design or intended purpose.
- Prepare evidence that your product does not present an unacceptable risk.
- Comply with EU MDR QMS requirements.
- Lodge an MDR assessment application.
What other changes are being proposed? #
Class III custom-made implantable devices #
The text proposes that class III custom-made implantable devices may continue to be placed on the market or put into service until 26 May 2026 without an MDR certificate, as long as they have lodged an assessment application with a Notified Body by 26 May 2024 (and a formally signed agreement with the Notified Body by 26 September 2024).
Removal of sell-off clause #
Another significant amendment is the removal of the “sell-off” clause. The original EU Regulations defined a deadline of 26 May 2025 after which all legacy devices and ‘old devices’ may not continue to be placed on the EU market. This deadline has now been effectively removed from both the EU MDR and IVDR.
Our Conclusions #
Without a doubt, this proposal will be welcomed by much of the industry which seems to be holding on to the Directives. However, manufacturers shouting “Hoorah!” will need to understand that there is no time to waste (more than ever) in transitioning to the new Regulations.
First of all, if you are eligible for the transition extension, you must have updated your quality management system by 26 May 2024. There is an obvious question here: “Who’s going to know?”. For higher risk devices, the Notified Body who has agreed to continue surveillance of your product under the Directive should be able to request evidence of this transition and may audit your system to ensure that you have met these new requirements. For those legacy devices which did not require Notified Body assessment under the EU Directive, one can only assume that their MDR Notified Body will be checking that they have made the appropriate move towards an MDR-compliant QMS. We’ll just need to wait and see how these assessments will pan out.
Secondly, you must submit an application for Notified Body assessment by 26 May 2024 (not on 26 May!!). An earlier application will no doubt be in everyone’s best interest, especially for higher risk devices. At the time of writing, there are 37 MDR-designated Notified Bodies out there. You will need check whether that organisation has the appropriate code to assess your device, but if you haven’t yet approached a Notified Body, the clock is ticking.
The removal of the sell-off date is really a fantastic improvement to a requirement which was, at times, rather perplexing. It will allow Directive-compliant devices to continue being placed on the market and will ensure the continued supply of such products for the time being.