21.03.2023
To the attention of manufacturers of medical devices, in vitro diagnostic medical devices, authorised representatives, economic operators and all stakeholders
We hereby inform you that on 20 March 2023, the European Commission has published Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
This Regulation is adopted following exceptional circumstances generated by an imminent risk of shortage of medical devices and the associated risk of a public health crisis.
Transitional provisions for medical devices
The certificates issued by notified bodies in accordance with the respective directives starting from 25 May 2017, which were still valid on 26 May 2021 and which expired before 20 March 2023, are considered valid until the dates specified in the table below only if one of the following conditions is met:
(a) prior to the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement for assessment of compliance related to the device covered by the expired certificate or related to a device intended to replace that device;
(b) a competent authority of a Member State has granted a derogation from the applicable compliance assessment procedure in accordance with Article 59(1) of Regulation 745/2017 or has requested the manufacturer, in accordance with Article 97(1) of Regulation 745 /2017, to carry out the applicable compliance assessment procedure.”;
Medical devices in the situation described above may be placed on the market or put into operation until the following dates:

Transitional provisions for in vitro diagnostic medical devices
Regulation (EU) 2017/746 is amended as follows:
1. Under Article 110, paragraph (4) is replaced by the following text:
„(4) Devices legally placed on the market in line with Directive 98/79/EC before 26 May 2022 and devices legally placed on the market after 26 May 2022 pursuant to paragraph (3) of this Article may still be placed on the market or put into service.”
2. Under Article 112, the second paragraph is replaced by the following text:
“As regards the devices referred to in Article 110 paragraphs (3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply to the extent necessary for the application of the said paragraphs.”
The notification of the European Commission is available online here: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#extension-of-the-transition-periods-provided-for-in-the-regulations
The European Commission has made available to interested parties a guideline on Questions and Answers on practical issues related to the implementation of Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices which can be downloaded from the European Commission’s website by accessing the following link:
https://health.ec.europa.eu/latest-updates/qa-practical-aspects-related-implementation-regulation-eu-2023607-extension-mdr-transitional-period-2023-03-28_en
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