Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs published

Last updated: 7 December 2023

See updates at the end of the post.

On 20 March 2023, Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs was published.

This Regulation entered into force on 20th March 2023, the day of its publication in the Official Journal of the European Union.

  • The Regulation introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions.
  • It also deletes in both MDR and IVDR the “sell-off” deadline after which devices placed on the market before or during the transition periods that are still in the supply chain would have had to be withdrawn.

Key changes to the MDR2

The key changes to the MDR include:

  • Extension of the transitional period for higher-risk devices (class III and certain class IIb implantables), such as pacemakers, to comply with EU MDR requirements until 31 December 2027, subject to certain conditions (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies).
  • Extension of the transitional period for medium and lower-risk devices (other class IIb devices, class IIa, class Im, Is and Ir devices), such as syringes, to comply with EU MDR requirements until 31 December 2028, subject to certain conditions (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies).

These changes to the EU MDR apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol.

The EU has also extended the validity of certificates issued by notified bodies under Directive 90/385/EEC and 93/42/EEC that were issued from 25 May 2017 and were still valid on 26 May 2021. This extension to the end of the relevant transition period set out above (being 31 December 2027 or 31 December 2028 depending on device class) applies to:

  • Certificates that expired before 20 March 2023 subject to meeting one of the conditions set out in the amendments to the EU MDR.
  • Certificates that were due to expire after 19 March 2023 so that they now expire at the end of the relevant transition period.

These extensions apply automatically in Northern Ireland. Certificates that have been extended will also be recognised as valid for placing CE marked devices on the GB market.

These changes made to the EU MDR will apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol.

Source: MHRA

What conditions do devices have to meet in order for the extension of the relevant transitional period to apply?5

Devices must meet the following conditions in order for the extension of the relevant transitional period to apply:

  • the device continues to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable
  • there are no significant changes in the design and intended purpose of the device
  • the device does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health
  • in accordance with Article 10(9) the manufacturer has put in place a quality management system (QMS) by 26 May 2024
  • the manufacturer or authorised representative has lodged an application for MDR certification with a notified body by 26 May 2024.
  • the manufacturer has signed a written agreement with a notified body by 26 September 2024.

Source: HPRA

Timeline to the publishing of Regulation (EU) 2023/607

Date EventAmends regulation(s)
20 Mar 2023 (published) Regulation (EU) 2023/607 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
The Regulation introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions. It also deletes in both MDR and IVDR the “sell-off” deadline after which devices placed on the market before or during the transition periods that are still in the supply chain would have had to be withdrawn.		Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (MDR)
7 Mar 2023The Council of the European Union (CEU) adopted the Commission’s proposal to give notified bodies and manufacturers more time to certify medical devices and thereby mitigate the risk of shortages.
16 Feb 2023The European Parliament voted overwhelmingly (a 537-3 vote, with 24 abstentions) to adopt a position at first reading, on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (COM(2023)0010 – C9-0003/2023 –2023/0005(COD)).
6 Jan 2023Adoption of a proposal by the European Commission on allowing more time to certify medical devices to mitigate the risk of shortages.
28 Jan 2022 (published)Regulation (EU) 2022/112 of 25 January 2022 introduced a staggered extension of the transition periods provided for in Regulation (EU) 2017/746 (IVDR) and deferred the application of conditions for in-house devices.

Whilst the IVDR has been applicable since 26 May 2022, the amendment allows for its progressive rollout regarding in vitro diagnostics covered by a certificate or a declaration of conformity issued in accordance with the previous IVD Directive 98/79/EC.		Regulation (EU) 2017/746 (IVDR) as amended
24 Apr 2020 (Published) Regulation 2020/561 of 23 April 2020 amending Regulation (EU) 2017/745 (MDR) on medical devices as regards the dates of application of certain of its provisions, postponed the entry into application of Regulation (EU) 2017/745 (MDR) by one year until 26 May 2021.Regulation (EU) 2017/745 (MDR) as amended.
Why was there a need for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices?6
  • Despite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC before 26 May 2024.
  • It appears that a large number of manufacturers, especially small and medium-sized enterprises, are not sufficiently prepared to demonstrate compliance with the requirements of Regulation (EU) 2017/745, in particular when the complexity of those new requirements is taken into account.
  • Therefore, it is very likely that many devices that can lawfully be placed on the market in accordance with the transitional provisions provided for in Regulation (EU) 2017/745 will not be certified in accordance with that Regulation before the end of the transitional period, which leads to the risk of shortages of medical devices in the Union.
  • In light of reports from healthcare professionals about the imminent risk of shortages of devices, it is necessary, as a matter of urgency, to extend the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC and to extend the transitional period during which devices that are in conformity with those Directives can lawfully be placed on the market.

Source: EU Monitor

Further information

1. Switzerland – MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured – Mar 2023

During the transitional phase, until the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) are amended, Swissmedic is already going ahead with enforcement in line with the recently published Regulation (EU) 2023/607 in order to to avoid jeopardising the supply of medical devices in Switzerland. Further information is available here.

Source: Swissmedic

2. Template for Notified Body – Confirmation letter in the framework of Regulation (EU) 2023/607 – May 2023

The commission has published a template (a confirmation letter template) confirming the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

You can view/download the template here.

Source: European Commission

3. Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 –July 2023

A 10 page Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 – Extension of the MDR transitional period and removal of the “sell off” periods is now available. You can download it here (Rev 1 July 2023). The document is divided in 5 parts as follows and contains eighteen Q&As.

  • PART A – SCOPE OF THE EXTENSION OF THE MDR TRANSITIONAL PERIOD
  • PART B – EVIDENCE OF EXTENDED TRANSITIONAL PERIOD
  • PART C – CONDITIONS TO BE FULFILLED TO BENEFIT FROM THE EXTENDED MDR TRANSITION PERIOD
  • PART D – APPROPRIATE SURVEILLANCE TO BE PERFORMED BY NOTIFIED BODIES
  • PART E – DELETION OF THE ‘SELL-OFF’ DATE

Source: European Commission

4. Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period – August 2023

A flowchart with the title below was published on 23 August 2023 to assist in deciding whether or not a device is covered by the extended MDR transitional period. You can view it here.

Conditions and deadlines for placing ‘legacy devices’ and class III custommade implantable devices on the market or putting them into service in accordance with Article 120 MDR, as amended by Regulation 2023/607

Source: European Commission

5. BSI resources

BSI has useful resources on this topic. Links to a small number of these resources are provided below:

  • MDR Transition timelines extended FAQs (BSI)
  • MDR Timeline (BSI)
  • MDR Dedicated page (BSI)
References:
  1. Extension of the transition periods provided for in the regulations, European Commission
  2. Extension of CE certificates UK MHRA
  3. Extension to MDR transitional provisions 22 Feb 2023 HPRA
  4. MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured 31 Mar 2023 Swissmedic
  5. Adoption of amendment to extend MDR and IVDR transitional provisions – HPRA Medical Devices Newsletter Issue 56 April 2023
  6. Considerations on COM(2023)10 – Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices – EU Monitor
Updates
DateUpdate(s)
7 Dec 2023The following changes were made in the section Further Information:
1) Link to document in point no 3 was updated.
2) Point no 5. BSI resources was added.
23 Aug 2023In the section Further Information, Item no 4 was added. It is a link to a flowchart with the following title:
Conditions and deadlines for placing ‘legacy devices’ and class III custommade implantable devices on the market or putting them into service in accordance with Article 120 MDR, as amended by Regulation 2023/607

The flowchart should assist you in deciding whether or not a device is covered by the extended MDR transitional period
18 Jul 2023In the section Further Information, information has been added to reflect the fact that the Q&A document was updated in July 2023.
24 May 2023Item no 3 (Template for Notified Body) added under the section Further Information.
16 Apr 2023New section What conditions do devices have to meet in order for the extension of the relevant transitional period to apply? plus relevant information added.
30 Mar 2023Section entitled Further information updated to add information on an update from Swissmedic.
29 Mar 2023Section entitled Key changes to the MDR updated to include additional information following an update on the UK MHRA website.
28 Mar 2023Section entitled Further information updated to include a link to the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.
22 Mar 20231) Section entitled Further information added.
2) Column entitled Amends regulation(s) moved to the end and links provided to the amended regulation wherever possible.