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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.

 

On December 9 2022, the European Commission proposed amendments related to EU Regulation 2017/745 – Medical Device Regulation [MDR] and Regulation 2017/746 – In-Vitro Diagnostics Regulation [IVDR].
 

These efforts are being taken to mitigate the risk of losing critical medical devices on the EU market, the European Commission adopted an urgent, targeted legislative initiative to amend the MDR/IVDR. In a recent press release,  the European council highlighted that:

 

Producers of medical devices will now have until December 31 2027, for higher-risk devices and until December 31 2028, for medium and lower-risk devices to meet the legal requirements.

The extension of the transition period will be granted under certain conditions. These ensure that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.

 

On January 6, the Commission adopted this proposal to give more time to certify medical devices and mitigate the risk of shortages. Finally, on March 7 2023, The EU Commission Proposal focusing on the Amendment of Transitional Deadlines was officially adopted and approved by all EU member states. 

 

Following the publication on March 15. The proposal has now become law and has been published on the  Official Journal of the European Union [OJEU]. 

 

Manufacturers should remember that the extension aims to relieve the supply chain and does not change the deadline for compliance with the MDR and IVDR, which remains May 26, 2021, and May 26, 2022, respectively.

 

What Amendments and compliance dates are introduced to EU MDR / IVDR?

 

As per the new amendments, Certain eligible Medical Devices and In-Vitro Diagnostic Devices will follow the following timeline:

• Class III Implantable custom-made devices: May 26 2026
• Class III & Class IIb devices: 31st December 2027
• Class IIb non implantable: December 31 2028
• Class IIb sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors : December 31 2028
• Class IIa and Class I (Is/Im): December 31 2028
• Extended validity of certificates issued up to May 26 2021
• Removes the 'sell-off' date for MDR & IVDR

These extended timelines does not change the deadline for compliance with the MDR and IVDR, which remains May 26, 2021 and May 26, 2022, respectively.

 

What should a Medical Device Manufacturer do with the EU MDR Transitional Deadlines?

1. Make sure your Quality Management Systems are in Place.
2. Ensure appropriate Transition plan from EU Medical Device Directives [EU MDD] to EU Medical Device Regulation are in Place.
3. Contact Experts at Med-Di-Dia who can support you with completing your transition plans, technical files and documents.
4. If you are yet to launch your medical device on the EU Market, speak to our experts, who can create a right Regulatory Roadmap for a smooth launch

We are here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!

Drop us an email at mdd@mddltd.com

 

Manufacturer’s Declaration in relation to Regulation (EU) 2023/607

 

Ahead of the upcoming deadlines, MedTech Europe  has published a template for Manufacturer’s Declaration to facilitate compliance with Regulation (EU) 2023/607 and:

• The validity of certificates issued for Legacy Devices under Council Directive 90/385/EEC or Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MDD) (Directive Certificates) and/or
• The compliance of the Legacy Devices and their manufacturer with the conditions for the continued placing on the market and putting into service.

Find out more detials - Click Here

 

Remember, These extended timelines introduced via REGULATION (EU) 2023/607 does not change the deadline for compliance with the MDR and IVDR, which remains May 26, 2021 and May 26, 2022, respectively.

 

All devices that do not meet the criteria and/or the status of legacy device must be compliant with respective regulations.