The European Commission has recently taken measures to guarantee the availability of medical devices on the market once the date of validity of the CE marking certificates under which they are marketed has passed, by publishing on 20 March, Regulation (EU) 2023/607.
This regulation extends the transitional period during which medical devices may be legally placed on the market“legacy”complying 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, theGuide to questions and answers.
The CNC team welcomes this measure, since in view of the experience gained in the dossiers received, the certification deadlines of the products 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 carried out automatically if the established conditions are met.
Given that 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 prepare a responsible declaration containing references to compliance with the following conditions of Article 120 (3c) (a), (b) (c) and (d).
- That the products continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as appropriate;
- That there are no significant changes in its design or in its intended purpose;
- That the products do not present an unacceptable risk to the health or safety of patients, users or others, or to other aspects of public health protection;
- By 26 May 2024 inclusive, the manufacturer has implemented a quality management system in accordance with Article 10(9) of the MDR
To prepare this statement, it is recommended that the manufacturer use agreed 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 at the latest, 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 by 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 to the CNC, Notified Body 0318?
Manufacturers who have signed the agreement with the CNC for the certification of medical devices according to the MDR, if they wish, can request the confirmation letter through the CNC telematics application – National Center for Certification of Medical Devices (aemps.es) without applying any emission cost.
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 CNC application. The application must provide the form DEX_03 “Request for letter of confirmation Regulation (EU) 2023/607” and the existing agreement signed by the manufacturer and by the CNC (R_DEX_02 and/or R_DEX_22)
The agreement signed by the CNC is provided once the steps set out in the information brochure R_DEX_01 have been followed“Information and conditions”.
The confirmation letter drawn up by the CNC 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.