MDCG 2020 -3 Rev 1

Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.

 

Are you a medical device manufacturer with AIMDD/MDD certificate and looking for the latest product guidance?

This update is for YOU!

 

The Medical Device Coordination Group [MDCG] published an - UPDATE - MDCG 2020-3 Rev.1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR - May 2023

This revision has Adjustments all over the document to align it to Regulation (EU) 2023/607 and guidance MDCG 2022-2.

 

As you know that as per Regulation (EU) 2023/607 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 do not change the deadline for compliance with the MDR and IVDR, which remains May 26, 2021, and May 26, 2022, respectively.

What Does MDCG 2020- 3 Rev 1 bring with it?

 

Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with the AIMDD or MDD may be placed on the market or put into service until December 31 2027 or December 31 2028, as applicable, provided the conditions set out in Article 120(3c) MDR are fulfilled. These devices are called ‘legacy devices’ and in line with MDCG Guidance Document 2021-25, ‘legacy devices’ should be understood as devices, which, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR’s date of application (i.e. May 26 2021) if certain conditions are fulfilled.

 

Those devices can be:

• devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration of conformity was drawn up prior to May 26 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
• devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to May 26 2021.

It is essential for legacy devices that their certificates remain valid following changes that are not significant with regard to design or intended purpose and that the required appropriate surveillance is carried out. The first revision of this guidance document MDCG 2020-3 on significant changes regarding the transitional provisions under Article 120(3) MDR takes into account the experience gained with the application of the original version so far, is aligned with the equivalent guidance for IVDs, MDCG 2022-May 6 20229 and adjusted to Regulation (EU) 2023/607.

 

MDCG  2020-3 Rev.1 intends to provide clarification on the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices. 

As a manufacturer, you need not worry about this document as it does not elaborate on the submissions process. Rather, focus on the essential part to understand what is considered as a ‘significant change’.

As you know, not all medical devices are benefitting from the extended transitional period, and these devices need to continue with the steps recommended by our experts.

 

MDCG  2020-3 Rev.1 highlights charts which help in Assessment whether changes are ‘significant changes in the design or intended purpose’ in accordance with Article 120(3c), point (b) MDR.

Our Experts have extracted the charts and will be emailed to you once you fill in this interest form.  [ https://mailchi.mp/a3744c8d52c0/eumdr ]

 

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

• Make sure your Quality Management Systems are in Place.
• Ensure appropriate Transition plan from EU Medical Device Directives [EU MDD] to EU Medical Device Regulation are in Place.
• Contact Experts at Med-Di-Dia who can support you with completing your transition plans, technical files and documents.
• 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