March 20, 2023
In the past months we have been informing you about the proposal of the European Commission amending Regulations (EU) 2017/745 and (EU) 2017/746 regarding the transitional provisions for certain medical devices and in vitro diagnostic medical devices. We also want to inform you of the guidance document with frequently asked questions related to the amendment that will extend the MDR transitional period and abandons the “sell-off” period for both medical devices and IVDs.
The amended Regulation (EU) 2023/607 has been published in the Official Journal of the European Union (OJEU), March 20, 2023, and gone into effect directly.
As a reminder, the amended regulation:
- Extends the validity of certificates issued under the Medical Devices Directives (MDD) that were valid on the day of the MDR’s date of application (26 May 2021) and have not been withdrawn by a Notified Body. The extension is directly applicable, so that Notified Bodies are not required to change the date on the individual certificates. The length of the extension of the certificate’s validity corresponds to the length of the extended transition period laid down in the proposed Article 120(3a) to (3c) of the MDR.
- The extension for certificates expired when the proposed amendment comes into force would be subject to the condition that:
- At the moment of the expiry, the manufacturer has signed a contract with a Notified Body for the conformity assessment of the device in question
- Alternatively, a national competent authority may have granted a derogation in accordance with MDR Article 59
- Or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with MDR Article 97
The expected Questions and Answers: On practical implementation of the extension of the Medical Devices Regulation (MDR) transitional period, has unfortunately not been published yet, but is expected soon. Currently, only the previously published Q&A: Medical Devices Regulation (europa.eu) is available. Emergo will inform you as soon as the new Q&A is published on the EC website. If you have questions in the meantime, such as how to justify that you are covered by the amended Regulation (EU) 2023/607, just contact us.
Do you want to know whether your certificates are extended and what conditions need to be met, such as having a signed agreement in place with a Notified Body to transfer the devices to the MDR? Contact Emergo by UL to assist with finding a Notified Body or assist in Technical File compilation.
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