UK updates post-Brexit medical device guidance
January 4, 2022
EU Steps to Market
January 6, 2022Page Last Updated: 19 July 2024
High-level: legacy devices are those that held valid CE marking under the old EU Directives (MDD/AIMDD/IVDD) on the day the MDR/IVDR went into effect and met the specified conditions. These are eligible for a longer transition period to CE Mark under the MDR/IVDR. Devices that did not hold valid CE marking on the MDR/IVDR dates of application are not considered legacy devices and must comply with the MDR/IVDR before being placed on the market.
What are Legacy Devices?
Medical Devices
- Devices that had a valid MDD/AIMDD CE Marking certificate on 26 May 2021 and that did not expire before 20 March 2023.
- Devices that had a valid MDD/AIMDD CE Marking certificate on 26 May 2021 but expired prior to 20 March 2023, if the following conditions are met:
- it was not withdrawn by the Notified Body; and
- before the CE certificate expired the manufacturer either had a signed written agreement in place with the Notified Body or had been granted an Article 59(1) derogation or Article 97(1) authorization by an EU Competent Authority.
- Devices that were Class I self-certified under the MDD, but were up-classed under the MDR; and for which a Declaration of Conformity was lawfully drawn up prior to 26 May 2021.
IVDs
- Devices that had a valid IVDD CE Marking certificate on 26 May 2022.
- Devices that were self-certified under the IVDD, but were up-classed under the IVDR; and for which a Declaration of Conformity was lawfully drawn up prior to 26 May 2022.
Custom-made Devices
Class III implantable custom-made devices have been granted a further transition period to obtain conformity assessment certification from a Notified Body. These products may be lawfully placed onto the market without a conformity assessment certificate until 26 May 2026, provided that they: 1) lodged a formal application with a notified body no later than 26 May 2024 and 2) have signed a written agreement with a Notified Body no later than 26 September 2024.
Conditions to Remain as a Legacy Device
All Legacy Devices (MDR/IVDR)
The following conditions apply to all legacy devices:
- The device must continue to comply with the MDD/AIMDD/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 devices
Medical Devices – Additional Requirements
The following deadlines must be met. If a product does not meet the below conditions, then it ceases to be a legacy device.
- May 26, 2024: no later than this date, put in place a quality management system in accordance with MDR Article 10(9)
- May 26, 2024: no later than this date, lodge an MDR application with a Notified Body
- September 26, 2024: no later than this date, have a signed MDR agreement in place with a Notified Body
IVDs – Additional Requirements
The following deadlines must be met. If a product does not meet the below conditions, then it ceases to be a legacy device.
| Classification | Deadlines |
|---|---|
| All risk classes | 26 May 2025 – Implement IVDR quality management system |
| IVDD Notified Body CE Marked | 26 May 2025 – Lodge application with Notified Body 26 September 2025 – Have signed agreement with Notified Body 31 December 2027 – Have IVDR CE marking (i.e., end of transition period) |
| Class D | 26 May 2025 – Lodge application with Notified Body 26 September 2025 – Have signed agreement with Notified Body 31 December 2027 – Have IVDR CE marking (i.e., end of transition period) |
| Class C | 26 May 2026 – Lodge application with Notified Body 26 September 2026 – Have signed agreement with Notified Body 31 December 2028 – Have IVDR CE marking (i.e., end of transition period) |
| Class B | 26 May 2027 – Lodge application with Notified Body 26 September 2027 – Have signed agreement with Notified Body 31 December 2029 – Have IVDR CE marking (i.e., end of transition period) |
| Class A sterile | 26 May 2027 – Lodge application with Notified Body 26 September 2027 – Have signed agreement with Notified Body 31 December 2029 – Have IVDR CE marking (i.e., end of transition period) |
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Transition Period Timeframe
Medical Devices
Per Regulation 2023/607, MDD/AIMDD legacy devices may remain on the European Single Market until:
- Class IIb implantable and Class III devices* – 31 December 2027
- Class IIb (all other), Class IIa, Class I sterile/measuring and Class I self-certified devices – 31 December 2028
*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
IVDs
Per Regulation 2024/1860, IVD legacy devices may continue to be placed onto the European Single Market until:
- IVDD Notified Body CE Certified – 31 December 2027
- Class D – 31 December 2027
- Class C – 31 December 2028
- Class B – 31 December 2029
- Class A sterile – 31 December 2029
What is not 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.
Further:
- Medical devices that were Class I self-certified under both the MDD and MDR, are not legacy devices. To remain on the market, these were required to CE Mark under the MDR by its date of application.
- IVDs that were self-certified under both the IVDD (“all other”) and IVDR (“Class A non-sterile”) are not legacy devices. To remain on the market, these were required to CE Mark under the IVDR by its date of application.
MDR/IVDR: Sections that Apply to Legacy Devices
MDR/IVDR sections related to post-market surveillance, market surveillance, vigilance, registration, and MDR/IVDR Article 10 quality system requirements apply to all legacy devices.
The MDCG has published guidance to help clarify the requirements: MDCG 2021-25 for medical devices and MDCG 2022-8 for IVDs. These are generally aligned in regard to which sections are applicable to legacy devices.
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) on quality system requirements | “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 | 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” |
Legacy Device Change Assessment Tool
Confirm if your MDD/AIMDD/IVDD device change is non-significant, allowing it to maintain its legacy status. Or, if the change is significant and requires MDR/IVDR CE Marking.
What is Considered a ‘Significant’ Change?
The Medical Device Coordination Group (MDCG) has released guidance documents related to ‘significant’ changes for legacy devices.
MDD/AIMDD Legacy Devices – MDCG 2020-3 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, thereby requiring MDR CE Marking in order to be marketed with this change.
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.
