3 May 2023
After the third extension of MDR (EU) 2017/745, formalised by Regulation 2023/607, it is increasingly difficult for manufacturers of legacy devices to understand where they stand in the transition process, what deadlines apply to the product, and the real, actual actions to be taken now.
Here are the 5 key insights you absolutely need to know now, in order to put in place the most effective strategic and operational solutions and to keep marketing legacy devices even after 26 May 2024, in compliance with regulations.
1 – Define the MDR classification of the legacy device
In order to meet the objectives just described, Regulation 2023/607 stipulates that legacy devices may be placed on the market or put into service until the following dates:
- for high-risk devices, i.e. class III and class IIb implantable devices (with the exception of suture materials, staples, dental filling materials, dental braces, tooth crowns, screws, wedges, plates and prostheses, wires, pins, clips and connectors) the transitional period is extended from 26 May 2024 until 31 December 2027;
- for medium and lower-risk devices, i.e. Class IIb, other than those in the previous point and class IIa, Im, Is and Ir devices, the transitional period is extended until 31 December 2028;
- for class III custom-made implantable devices, with a manufacturer’s application for conformity assessment prior to 26 May 2024, the transition period is extended until 26 May 2026.
Consequently, in order to be able to establish for sure how long a device can be marketed, it is necessary to proceed immediately with an MDR classification assessment, since it is explicitly stated in the Questions&Answers guideline that the classification to be considered is the one provided for in Annex VIII of MDR (EU) 2017/745.
2 – Identify the Notified Body
Legacy devices benefit from the third MDR extension only if an agreement between the manufacturer and a Notified Body for MDR (EU) 2017/745 certification of the device covered by the expired certificate or its replacement has been signed – in accordance with Annex VII, point 4.3, second paragraph – before the expiry of the certificate.
It is therefore necessary to identify as soon as possible the Notified Body that will be in charge of MDR certifying the device, activate the collaboration and sign the agreement within the deadline. Considering that today many Notified Bodies have very long lead times, even just for issuing a commercial proposal, it is not a good idea to wait any longer!
3 – Adapt the quality management system to (all requirements of) MDR
It is already clear that the application of the extended transition period is subject to several conditions, including the implementation of a fully MDR-compliant Quality Management System by 26 May 2024.
Whereas with the second extension only the processes mentioned within Art. 120 (i.e. post-market surveillance, market surveillance, vigilance, registration of Economic Operators and devices) could be adapted for legacy devices, with MDR 2023/607 the need is defined to adapt the entire Quality Management System of the Manufacturer, in all its processes, to all requirements included in MDR (EU) 2017/745 and to do so no later than 26 May 2024.
The Quality Management System documentation is also included in the application for conformity assessment submitted to the Notified Body, as specified in the Questions&Answers guideline.
Considering that the requirements are significant, numerous and of great impact for the organisation, it is advisable to manage this activity from the outset: the Notified Body will not fail to monitor it during maintenance inspections and will probably request an internal audit.
4 – No significant changes to the device
A further condition for continuing to market the legacy device is that no significant changes be made to the design and intended use of the device.
We have already discussed this, but to help understand whether or not a change can be considered significant in the design or intended use of the device under Article 120, c. 3 MDR, we confirm that MDCG Guideline 2020-3 “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD” remains of reference.
It is therefore necessary to adjust the change management process in design, production and the other processes involved right away, to make sure that you have implemented the change assessment criteria correctly and to check whether you have all the tools you need for (documented) change assessment in accordance with the guideline.
5 – Start drafting the MDR Technical Documentation
The signing of the agreement with the Notified Body to initiate the conformity procedure to MDR (EU) 2017/745 may entail the forwarding to the latter of a minimum structure or group of general documents already adapted to the regulation.
This means that, following the acceptance of the certification proposal, the product documentation to be reviewed by the body must be ready, available and forwarded: in the absence or inadequacy of the minimum information, problems may arise in finalising the agreement within the deadline.
>>> What can Thema do?
As seen, the MDR classification assessment is an essential regulatory strategy tool to take advantage of the extension for legacy devices.
The report resulting from the assessment will not only have to be included in the Technical Documentation, but will also likely have to be sent to the Notified Body for the finalisation of the certification agreement, as well as being a decisive element in identifying the right extension period.
To maintain commercialisation of the legacy device, having a Quality Management System compliant with ISO 13485:2016 for the manufacturer is not sufficient. Thema Experts can offer support in implementing business processes to make them fully compliant with all applicable MDR requirements.
Having obtained CE certifications for its customers in accordance with MDR (EU) 2017/745, Thema can provide facilities, content and help with the drafting of the Technical Product Documentation, as well as manage the relationship with the Notified Body, provide support in the assessment of significant changes and in meeting the requirements of the extension.
You got it right: many services one partner.
Let’s take care beyond the boundaries.
Sources
