Over the past 20 years, the medical device and in vitro diagnostics sector has undergone significant changes, and the EU has updated its laws to keep pace with these changes. This means that new rules were created to ensure that medical devices and tests are safe and effective for people to use.
Legacy devices refer to medical devices (MD), active implantable medical devices, and in vitro diagnostic medical devices (IVD) that were previously placed on the European market (EU) in compliance with the previous Directives 93/42/EEC, 90/385/EEC, or 98/79/EC and can still be legally sold in the EU after the implementation of the new European Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation IVDR 2017/746 (IVDR).
However, all legacy devices must adhere to the new regulations to ensure safety and effectiveness for users in the following areas: post-market surveillance, market surveillance, vigilance, registration of economic operators and registration of devices. In all other aspects, legacy devices must continue to comply with the MDD or IVDD, provided no significant changes in design or intended purpose are made.
The manufacturers must register legacy devices in the Eudamed database by the end of the transition period. Isted of basic UDI-DI and UDI-DI, an identification element called EUDAMED DI (the equivalent of the Basic UDI-DI) will be generated from the EUDAMED for these devices.
The MDR entered into force in May 2017. As a result of the COVID-19 pandemic, the implementation of MDR was delayed by one year until May 26, 2021, according to Regulation (EU) 2020/561 of the European Parliament and the Council. The transition period provided for in the Regulation was maintained on 26 May 2024. However, on 7 March 2023, the Council of the European Union adopted the Commission’s proposal to give notified bodies and manufacturers more time to certify MD and mitigate the risk of shortages. The legislative proposal provides a longer transition period to adapt to new rules foreseen under the MDR, ensuring continued access to MD for patients in need. In the table bellow, we have gathered all the important dates related to legacy devices. Following this important adoption by the Council, the proposed amendment to the MDR is expected to be formally adopted by both the European Parliament and the Council on 15 March 2023. Shortly after, it will be published in the Official Journal and enter into force on the day of its publication. The proposal also includes the removal of the ‘sell-off’ deadline stated in the relevant provisions of MDR and IVDR.
The IVDR also entered into force in May 2017. The IVDR became applicable on 26 May 2022. The transition period provided for in the Regulation was maintained on 26 May 2024. However, the European Parliament and the Council adopted a staggered extension of its transition period for IVD in January 2022. See the table bellow for exact dates.
In the table below are listed the most important dates related to legacy devices. The proposed extension to the transition periods apply only to ‘legacy’ devices:
|Regulation entered into force||25.5.2017||25.5.2017|
|Date of application of the new Regulation1)||26.5.2021||26.5.2022|
|Transitional period set when both Regulation come into force1)||27.5.2024||27.5.2024|
|Transition period prolonged in January 20222)||Class A sterile –26 May 2027
Class B – 26 May 2027
Class C – 26 May 2026
Class D – 26 May 2025
IVDs with Notified Body issued IVDD CE Marking certificates – 26 May 2025
IVDs used in health institutions – 26 May 2028
|Transition period prolonged in March 20233)||Class III and class IIb implantable devices – 31 December 2027
Other class IIb devices, class IIa and class I (sterile or with measuring function) – 31 December 2028
MD which from now on need conformity assessment procedure – 31 December 2028
Class III custom-made implantable devices – 26 May 2026(e)
1) Due to the impact of the COVID-19 pandemic, the date of application of MDR has been postponed by one year to 26 May 2021 by Regulation (EU) 2020/561 of the European Parliament and of the Council, while the date of 26 May 2024 was maintained as end of the transition period by which certain devices that continue to comply with Directive 90/385/EEC or Directive 93/42/EEC may be placed on the market or put into service
2) In January 2022, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 26 May 2025 for highrisk in vitro diagnostics to 26 May 2027 for lower risk in vitro diagnostics, and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions (Regulation (EU) 2022/112).
3) On 7 March 2023, the Council of the EU approved the European Commission’s proposal, supported by the European Parliament, to amend the transitional provisions in MDR and IVDR.
Despite the efforts to implement the MDR and the IVDR, the transition of MD and IVD to the new rules has faced significant challenges and delays. Factors such as limited notified body availability and capacity, shortages in the supply of raw materials in the EU, and manufacturers’ lack of preparedness have contributed to these issues. To avoid any potential disruptions to the supply and availability of MD and IVD on the EU market that could impact patient health, the Council of the European Union has adopted the Commission’s proposal allowing safe legacy devices to continue being sold in the EU after the current transitional period has ended.