The European Commission has recently taken measures to guarantee the availability of medical devices on the market once the validity date of the CE marking certificates under which they are marketed has passed, publishing on 20 March, Regulation (EU) 2023/607.
This regulation extends the transitional period during which medical devices can be legally placed on the market“legacy”in accordance with Directive 93/42/EEC (MDD) provided that certain conditions are met.
In order to facilitate the correct interpretation of the conditions established for the extension, thequestion and answer guide.
The CNCps team welcomes this measure, as in view of the experience gained in the dossiers received, product certification deadlines are being longer than expected due to the demanding and rigorous requirements established in the new legislation for both manufacturers and notified bodies.
How can manufacturers demonstrate compliance with the conditions for the transition?
The extension of the transitional period and the corresponding validity of the certificate are performed automatically if the established conditions are met.
As notified bodies will not issue new EC certificates in accordance with the MDD by changing the expiry dates, the need to prove to third parties the validity of the “expired” certificates after their expiry date is recognised.
In this regard, the Q&A Guide identifies the possibility for manufacturers to make a responsible declaration containing references to compliance with the following conditions of Article 120(3c)(a), (b)(c) and (d).
- The products continue to comply with the provisions of Directive 90/385/EEC or Directive 93/42/EEC, as appropriate;
- That there are no significant changes in its design or its intended purpose;
- That the products do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of public health protection;
- Up to and including 26 May 2024, the manufacturer has implemented a quality management system in accordance with Article 10(9) MDR
To make this statement, it is recommended that the manufacturer use consensual models developed by associations of manufacturers.
On the other hand, the evidence of compliance with point (e) of the same article:
- Until 26 May 2024 inclusive, the manufacturer or the authorised representative has submitted to the notified body, in accordance with the first paragraph of Section 4.3 of Annex VII, a formal request for the conformity assessment of a product or a product intended to replace it, and by 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with the second paragraph of Section 4.3 of Annex VII.
It is materialized through a letter of confirmation prepared by a notified body that acknowledges the receipt of the application for certification according to MDR and the existence of the agreement signed between both parties.
How can I request the confirmation letter from CNCps, Notified Body 0318?
Manufacturers who have signed the agreement with the CNCps for the certification of medical devices according to the MDR, if they wish, can request the confirmation letter through the telematic application CNCps – National Center for Medical Device Certification (aemps.es) without applying any emission costs.
The request is made by selecting:
- “EC monitoring of medical devices (MDD and IVDD)”
- “Post-certification monitoring”
- “CE Certificate Extension (Reg. 2023/607)” in the CNCps application. The application must provide form DEX_03 “Request for confirmation letter Regulation (EU) 2023/607” and the existing agreement signed by the manufacturer and by the CNCps (R_DEX_02 and/or R_DEX_22)
The agreement signed by the CNCps is provided once the steps set out in the information leaflet R_DEX_01 have been followed“Information and conditions”.
The confirmation letter drawn up by the CNCps will conform to a harmonised model and contain the unambiguous identification of the products for which the manufacturer has applied for certification under MDR, which are the ones that will benefit from the extended transitional periods.