What are Legacy Devices?
UK updates post-Brexit medical device guidance
January 4, 2022
EU Steps to Market
January 6, 2022Medical Device legacy devices are:
MDD 93/42/EEC Class I self-certified devices, which had MDD CE marking before the MDR’s date of application, and were up-classed under the MDR and therefore no longer self-certified under the MDR
MDD 93/42/EEC Class I sterile/measuring, IIa, IIb and III devices with valid Notified Body issued MDD CE Marking certificates
AIMDD 90/385/EEC devices with valid Notified Body issued AIMDD CE Marking certificates
Medical device legacy devices may continue to be placed onto the European Single Market after the MDR’s date of application (26 May 2021), through:
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- 31 December 2027- Class IIb implantable and Class III devices*
- 31 December 2028 – Class IIb (all other), Class IIa, Class I sterile/measuring and Class I self-certified devices
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*The following devices are excluded and are eligible for the 31 December 2028 deadline: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
MDR, Article 120 (3 and 4) outlines which devices are eligible for the transition period.
Note that some aspects of the MDR begin applying to legacy devices on its date of application. See the FAQ section included in this post below for more details.
IVD legacy devices are:
IVDD 98/79/EC devices with valid Notified Body issued IVDD CE Marking certificates
IVDD 98/79/EC self-certified devices, which had IVDD CE marking before the IVDR’s date of application, and were up-classed under the IVDR and therefore no longer self-certified under the IVDR
IVD legacy devices may continue to be placed onto the European Single Market after the IVDR’s date of application (26 May 2022), through the following dates:
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- Class A sterile – compliance date of 26 May 2027
- Class B – compliance date of 26 May 2027
- Class C – compliance date of 26 May 2026
- Class D – compliance date of 26 May 2025
- IVDs with Notified Body issued IVDD CE Marking certificates – 26 May 2025
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IVDR, Article 110 (2 and 3) outlines which devices are eligible for the transition period.
Note that some aspects of the IVDR begin applying to legacy devices on its date of application. See FAQ section for more details.
Frequently Asked Questions
My device is self-certified under the old Directives, but higher risk under the MDR/IVDR. Can I place those devices on the EU market after the MDR/IVDR dates of application?
Possibly. Certain conditions apply in order to be an eligible legacy device.
Criteria
The self-certified device must have already had MDD/IVDD CE Marking on the MDR/IVDR’s date of application to be eligible for the transition period (i.e., to be considered a legacy device).
Where a manufacturer places a new device onto the market, i.e., one that did not yet have CE Marking by the MDR/IVDR date of application, then that device is not eligible for this transition period allowance. Meaning:
Any medical device newly CE marked after 26 May 2021, must be CE marked to the MDR.
Any IVD newly CE marked after 26 May 2022, must be CE marked to the IVDR.
Additional Conditions
The following conditions apply:
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- The device must continue to comply with the MDD/IVDD
- A valid Declaration of Conformity must be:
- Drawn up (and signed) prior to 26 May 2021 (medical devices) / 26 May 2022 (IVDs)
- No significant changes to the design or intended purpose of the device can occur after 26 May 2021 (medical devices) / 26 May 2022 (IVDs)
- Manufacturer must comply with the MDR/IVDR for the following, irrespective of having MDD/IVDD CE Marking:
- Post-market surveillance
- Market surveillance
- Vigilance
- Registration of economic operators and of devices
- Manufacturers of medical devices must put in place a quality management system in accordance with MDR Article 10(9) no later than 26 May 2024
- This requirement to implement a quality system by 26 May 2024 is not applicable to IVDs
Where these requirements are met:
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- MDD CE marked devices may continue to be placed onto the EU market until 31 December 2028.
- IVDs may continue to be placed onto the EU market based on the timelines provided in the above IVD section.
If a manufacturer intends to make a significant change to the design or intended purpose of the device, then the manufacturer should work with a Notified Body toward MDR/IVDR CE marking.
What is considered a ‘significant’ change?
The Medical Device Coordination Group (MDCG) has released guidance documents related to ‘significant’ changes.
MDD/AIMDD Legacy Devices – MDCG 2020-3
The guidance document provides feedback such as: “administrative changes of organisations are considered in principle as nonsignificant. This includes changes of the manufacturer’s name, address or legal form (legal entity remains) or changes of the authorised representative.”
It additionally provides a series of flowcharts to help manufacturers assess if a change may be considered significant.
IVDD Legacy Devices – MDCG 2022-6
Like the guidance for medical devices, the IVD legacy guidance document provides feedback and flowcharts of what may be considered a significant change.
For more information, please read: MDCG Guidance on IVDR Legacy Device Transition and Significant Changes
Which Sections of the MDR/IVDR apply to legacy devices?
MDR/IVDR sections related to post-market surveillance, market surveillance, vigilance and registration of economic operators and devices apply to all legacy devices.
The MDCG has published guidance to help clarify the requirements. MDCG 2021-25 for medical devices. MDCG 2022-8 for IVDs.
The following are examples extracted from the MDCG annexes and Regulation 2023/607, which amends the transitional provision of the MDR.
| MDR/IVDR Section | Applicable: YES/NO |
| MDR Art. 10(10), (12)-(15)/IVDR Art. 10(9), (11)-(14) – General obligations of manufacturers, specifically the sections related to post-market surveillance, market surveillance, vigilance and registration of economic operators and devices |
MDR – “YES (nota bene: ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR)” IVDR – “YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘IVD legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR)” |
| MDR Art. 10(9) | “YES” – Per EU Regulation 2023/607, which amends the MDR’s transitional provisions, medical device manufacturers must implement a quality management system as outlined in MDR Article 10(9) no later than 26 May 2024 |
| MDR/IVDR Art. 13(2) 2nd subparagraph, (4), (6)-(8), (10)- General obligations of importers, specifically the sections related to post-market surveillance, market surveillance, vigilance and registration of economic operators and devices |
MDR – “YES (nota bene: ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR)” IVDR – “YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘IVD legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR)” |
| MDR/IVDR Art. 15 – Person Responsible for Regulatory Compliance | “NO” |
| MDR Art. 27/IVDR Art. 24 – Unique Device Identification (UDI) system | “NO (See in this respect also MDCG 2019-5 on registration of legacy devices in Eudamed)” |
| MDR Art. 32/IVDR Art. 29 – Summary of safety and clinical performance/Summary of safety and performance | “NO” |
| MDR Art. 85/IVDR Art. 80 – Post-market surveillance (PMS) report |
MDR – “YES (classification of devices in class I follows classification rules of the MDD, i.e. Art. 85 applies to class I ‘legacy devices’ despite the fact that those devices might be in a higher class under the MDR)” IVDR – “YES, applicable to all ‘legacy devices’, unless manufacturer voluntarily prepares a PSUR pursuant to Article 81” |
What additional requirements are applicable for MDR legacy devices?
On 20 March 2023, the MDR’s transitional provisions were extended. The transition period was originally set to end 26 May 2024. However, Regulation 2023/607 has now extended the transition period to the following:
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- 31 December 2027- Class IIb implantable and Class III devices*
- 31 December 2028 – Class IIb (all other), Class IIa, Class I sterile/measuring and Class I self-certified devices
*The following devices are excluded and are eligible for the 31 December 2028 deadline: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors
Certain conditions must be met in order to remain a legacy device:
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- The device must continue to comply with the MDD/AIMDD
- Higher risk devices: the device must have had valid Notified Body CE marking on or before 26 May 2021, that was not withdrawn afterward
- Self-certified devices: the device must have had valid CE marking with a Declaration of Conformity drawn up on or before 26 May 2021
- No significant changes to the design or intended purpose of the device can occur after 26 May 2021 (medical devices)
- Manufacturer must comply with the MDR for the following, irrespective of having MDD/AIMDD CE Marking:
- Post-market surveillance
- Market surveillance
- Vigilance
- Registration of economic operators and of devices
- No later than 26 May 2024, manufacturers must put in place a quality management system in accordance with Article 10(9)
- No later than 26 May 2024, manufacturers of Class I sterile/measuring/reusable, IIa, IIb and III devices must have lodged an application with the Notified Body
- No later than 26 September 2024, the manufacturer and the Notified Body must have signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII
