On 18 July 2023, the European Commission published in the Official Journal of the European Union the updated guideline Questions&Answers (Q&A) entitled ‘Rev. 1 – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607’ to clarify certain aspects contained in Regulation 2023/607.

The most significant changes and innovations between the first issue and rev.1 are described:

• Flow charts will be made available to help manufacturers understand whether a device benefits from the transitional period provided for in Article 120 MDR.
• A legacy device and the corresponding MDR-compliant device may be placed on the market in parallel until the end of the relevant transition period.
• The derogation granted under Article 59 or the application of Article 97 after 20/03/2023 does not allow for the extension of the transitional period.
• A Medical Device that has been granted a derogation under Article 59 MDR may benefit from the transitional period even without the CE marking if the removal of the CE marking was a condition or consequence of the derogation granted by the national competent authority under Article 59 MDR.
• Concerning the relationship between Manufacturer and Notified Body, the Manufacturer may demonstrate that he has submitted an application for conformity assessment and concluded a written agreement with a Notified Body with a copy of the relevant documents in addition to a letter of confirmation or a self-declaration. Concerning the self-declaration, the industry associations EuromContact, EUROM VI and MedTech Europe at European level have developed a model of the Manufacturer’s declaration and it is available on their websites, COCIR, EuromContact, EUROM VI and MedTech Europe.
• With regard to surveillance, the Manufacturer must immediately inform the Notified Body if the latter has not yet carried out the activity so that it can retrieve it.
• If the Manufacturer were to withdraw the application for conformity assessment or if the written agreement between the Notified Body and the Manufacturer were to be terminated, the conditions of Article 120(3)(e) of the MDR would no longer be fulfilled and therefore the transitional period would no longer apply. However, should the Manufacturer simultaneously enter into a written agreement with another Notified Body, to which the application is transferred, the conditions of Article 120(3c) (e) would still be fulfilled and the transitional period would continue to apply.
• Administrative changes related to the organisation of the Manufacturer are not considered to be significant changes and consequently have no impact on the transition period. Situations in which the MDD/AIMDD-certified manufacturer transfers devices covered by MDD/AIMDD certificates to another manufacturer who intends to place such devices on the market under MDR are excluded, unless the MDD/AIMDD-certified manufacturer and the MDR-certified manufacturer are part of the same organisation.

The European Commission is therefore continuing its clarification activities in the implementation of Regulation 607 with a view to making it easier for manufacturers to use the extension and thus continue to provide assistance to public and private healthcare personnel.

>>>Through its strategic-regulatory consulting services, CE certification support and, if necessary, European authorised representative, Thema can help you implement the requirements of Regulation 2023/607 to benefit from the extension and the MDR (EU) 2017/745 Medical Device Regulation.

Contact us for information.

Source

Rev. 1 – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607