In early January, the EU commission put forward a proposal to extend the transition period for certain medical devices and the removal of the sell-off date for IVDR devices due to concerns of medical device shortages and notified body capacity. In February, the EU parliament has voted by a landslide in favour of the proposal where a total of 537 who voted in favour which mirrored the sentiment of many medical device manufacturers. There were a total of 3 who voted against the proposal and 24 who abstained from the vote.
The amendment will be law once it is published in the Official Journal of the European Union. Due to the urgent nature of the amendment, the European Parliament stated that it will skip the typical 20-day waiting period before publishing the amendment in the Official Journal of the European Union.
The official text can be accessed using the following link.
The new amendment will apply to the following devices;
1.Devices with a CE Certificate under the MDD/AIMDD
This new amendment will apply to your device if your medical device was certified by a notified body under the Medical Device Directive 93/42/EC (MDD) or the Directive on Active Implantable Medical Devices 90/385/EEC (AIMD) and valid at the date of application of the MDR (26 May 2021), and not later withdrawn by the notified body. Depending on whether the CE certificate in question expires prior or after the date of entry of this new amendment, certain conditions would have to be met, and certain criteria have to be satisfied.
1.1 CE Certificate Expires After the Date of Entry of the Amendment
If your certificate expires after the date of entry of the new amendment, then the device can continue to be placed on the market till 2027 or 2028 depending on the class and if certain criteria are met. (Kindly refer to Flowchart I – Flowchart for the Extension of CE certificates for the criteria that need to be met and the timelines that apply)
1.2 CE Certificate Expires Prior to the Date of Entry of the Amendment
Conversely, if your CE certificate expired prior to the date of this new extension legislation, you can still place the devices on the market if one of the following conditions is met:
- Prior to the expiration of the CE certificate, a written agreement has been signed between the manufacturer and a notified body for the conformity assessment of the device.
OR
- The manufacturer has applied for an Article 59(1) or Article 97(1) derogation in respect of the device and the Competent Authority has granted the derogation.
If you have one of the above agreements in place, then the device can continue to be placed on the market till 2027 or 2028 depending on the class and if certain criteria are met. (Kindly refer to Flowchart I – Flowchart for the Extension of CE certificates for the criteria that need to be met and the timelines that apply)
2. Class I Devices under the MDD that have been Up-Classified under the MDR.
The extended provisions also apply if your medical device was a Class I device under the MDD, which did not require the involvement of a notified body, and is up classifying under the MDR, and requires the involvement of a notified body for CE certification and has a Declaration of Conformity that has been drawn up prior to 21 May 2021. These devices can continue to be placed on the market till 2028 if certain criteria are met. (Kindly refer to Flowchart II – Flowchart for the Up-Classification of Devices for the criteria that need to be met and the timelines that apply)
3. Class III Custom Made Implantable Devices
The new amendment also applies if your Device is a Class III Custom Made Implantable Device. These devices can continue to be placed on the market till 2026 if certain criteria are met. (Kindly refer to Flowchart III – Flowchart for Device Class III Custom Made Implantable for the criteria that need to be met and the timelines that apply)
MDR & IVDR Sell-Off Date Removal
Lastly, the amendment deletes the current ‘sell-off’ date established in the MDR (27 May 2025) and IVDR (25 May 2025 – 26 May 2028). This implies that devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction.
Advena Guidance
Advena has drafted a guidance document regarding this amendment which intends to help manufacturers navigate the ever-changing landscapes of the MDR and IVDR. The guidance will also provide a timeline with all the important cut-off dates, FAQ’s and flowcharts to better understand and visualise the process more effectively.
The guidance will be made available once the amendment is published in the Official Journal of the EU.
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