“Legacy” medical devices and IVDs under EU legislation

The new EU regulations on medical devices and in-vitro diagnostic devices allow devices CE-marked per the former EU directives to still be placed on the market under certain conditions. Such devices are referred to as “legacy devices”.
If you are uncertain about the legacy qualification of your medical device or in-vitro diagnostic device (IVD), or you wish to know more about how legacy devices are regulated under the EU MDR or IVDR, read on.

Key takeaways:

• If your Class I device or self-declared IVD will not require the involvement of a Notified Body under the EU MDR or IVDR, it does not qualify as “legacy” and should already be in compliance with the new Regulation.
• Changes in device design or intended purpose trigger the loss of the “legacy” status. Make sure you are familiar with the restrictions and that your change management process is aligned.
• Transition periods for legacy devices are changing as we write. Check the latest timelines and applicable conditions in this article. And do not forget that, for foreign manufacturers, all legacy devices sold in Switzerland require a Swiss Authorised Representative.

Content:

When does a CE-marked device (medical device or IVD) qualify as legacy device?

Per guidance document MDCG 2021-25, legacy devices under the EU regulations on medical devices (Reg. 2017/745, EU MDR) are those covered by the transitional provisions in Article 120(3), i.e. those placed on the market after the 26 May 2021 and until 26 May 2024 (end of the initial transitional period under the EU MDR, now being extended), provided certain conditions are fulfilled.

And, per guidance document MDCG 2022-8, legacy devices under the EU regulations on in-vitro diagnostic devices (Reg. 2017/746, IVDR) are those covered by the transitional provisions in Article 110(3), i.e. those placed on the market or put into service after 26 May 2022 and until the end of the respective transition period set out in Article 110(3), provided certain conditions are fulfilled.

Note that devices that were last placed on the market before the date of application of the corresponding regulation are considered to be “old devices”, not legacy devices. Despite the fact that old devices may remain used in the field for a long time (e.g. surgical equipment, laboratory centrifuges for IVD testing), they are not subject to the EU MDR or IVDR requirements, with the exception of serious incident reporting. See section What EU MDR or IVDR requirements apply to legacy devices? for details.

Summarizing the respective conditions, the following devices qualify as legacy:

• all medical devices and IVDs with a valid certificate (issued in accordance with the former MDD, AIMDD or IVDD), and 
• those devices that did not require the involvement of a Notified Body for CE marking under the former Directives but would now require so under the EU MDR or IVDR.

This means that the following categories are NOT considered legacy devices:

• Class I devices (non-sterile and without measuring function) under the MDD that would remain Class I devices under the EU MDR without the involvement of a Notified Body. This would be the case for Class I devices that do not have a measuring function (i.e. Class Im), are not sterile (i.e. Class Is) and are not surgically reusable devices (i.e. Class Ir) under the EU MDR.
• Self-declared IVDs (non-sterile) under the IVDD that would correspond to non-sterile Class A IVDs under the IVDR.

A legacy device cannot undergo any significant changes. If a significant change is made to a legacy device, it loses legacy device status and must go through the EU MDR or IVDR approval process fulfilling all the relevant EU MDR or IVDR requirements. See more details under What changes entail losing a legacy device status under the EU MDR or IVDR?

What about Custom-made devices?

According to the definition in EU MDR Article 2(3), custom-made device means: 
“any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs” 

In summary this means that custom-made devices are medical devices that are given design properties to match a specific patient’s needs (i.e. not mass produced). A classic example of a custom-made device is a prosthetic limb. The device is made on prescription issued by an authorised person (i.e. a specialist doctor such as an orthopedist).

Custom-made devices are not covered by the transitional provisions in EU MDR Article 120. Thus, they do not qualify as legacy devices and must comply with EU MDR requirements since 26 May 2021. This initially included Class III implantable custom-made devices, which now require Quality Management System (QMS) certification by a Notified Body, per EU MDR Article 52(8). However, per the EU Commission’s proposal of amending Regulation to extend the EU MDR transitional provisions that was published on 6 January 2023 (2023/0005 (COD)), the certification can be postponed until 26 May 2026, provided the manufacturer has lodged a formal application with a Notified Body by 26 May 2024 and signed the corresponding written agreement by 26 September 2024. In practice, this newly granted “grace period” will basically benefit serious laggards as compliant manufacturers had already transitioned to the EU MDR and obtained the corresponding Notified Body’s certificate for their QMS on or around 26 May 2021.

Custom-made devices are not CE marked. However, a manufacturer of custom-made devices must still follow EU MDR requirements. This includes implementation of Annex XIII, and registering in EUDAMED as an actor, even if UDI requirements do not apply. MDCG 2021-3 provides details on the different aspects of the EU MDR that a manufacturer of custom-made devices must observe.

What changes entail losing a legacy device status under the EU MDR or IVDR?

There are three ways that legacy devices can lose their legacy status:

• through significant changes to the device design or intended purpose,
• by reaching the end of the corresponding transitional period in the EU MDR (which are being extended) or IVDR (which were extended last year),
• due to expiration of the Notified Body certificate issued under the MDD/AIMDD or IVDD before the new certificate under the EU MDR or IVDR becomes available, although waivers are being implemented by the EU Commission to avoid this situation.

Significant changes

A device loses its legacy status if it undergoes a significant change to design or intended purpose. If the device undergoes a significant change it must go through the EU MDR or IVDR approval process fulfilling all the relevant EU MDR or IVDR requirements, as applicable.

Design changes may sound simple and narrow, but the term is used in its broadest sense as can be seen below in the list of changes summarizing changes identified in guidance documents MDCG 2020-3 (concerning the EU MDR) and MDCG 2022-6 (concerning the IVDR) on when change significance needs to be evaluated:

* Design changes related to corrective actions are considered non-significant as long as the change is non-significant from an IVDR Article 110(3) perspective and the change has been assessed and accepted by the relevant competent authority.

For more details on significant changes under the EU MDR, see our blog article Guidance on medical device significant changes.

A device loses its legacy status if it undergoes a significant change to design or intended purpose.

Transitional periods

The below transitional timelines to upgrade CE-marking from the former Directives to the EU MDR or IVDR, as applicable, have been granted to legacy devices:

• For non-IVDs, per EU MDR Article 120(3): initially 26 May 2024.
  However, due to the limited availability of Notified Bodies which is causing delays in certification under the EU MDR, the EU Commission has drafted an amending Regulation 2023/0005 (COD) that extends the initial transitional period under certain conditions, as follows:
  • For Class III devices and implantable Class IIb devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors): until 31 December 2027.
  • For other Class IIb devices, Class IIa devices, and Class Is/m devices: until 31 December 2028.
  • For devices that did not require the involvement of a Notified Body under the MDD (e.g. Class I, EU MDR Annex XVI products) and would require so under the EU MDR: until 31 December 2028.
  • Conditions include:
    • no unacceptable risk for health and safety, 
    • no significant changes to the device design and intended purpose,
    • manufacturer’s QMS in accordance with EU MDR Article 10(9) is in place no later than 26 May 2024,
    • proof of formal application with a Notified Body for the transition to the EU MDR by 26 May 2024 and the written agreement with the Notified Body is signed no later than 26 September 2024.
  • In addition, implantable Class III custom-made devices, that under the EU MDR require a QMS certificate issued by a Notified Body and did not qualify as “legacy devices”, they can now remain on the market without such certificate until 26 May 2026, provided a formal application with a Notified Body has been lodged by 26 May 2024 and the written agreement with the Notified Body is signed no later than 26 September 2024.
• For IVDs, two different situations apply:
  • For legacy IVDs with a Notified Body certificate under the IVDD, per IVDR Article 110(3) second subparagraph: until the expiration of the certificate or at the latest until 26 May 2025.
  • For legacy IVDs without a Notified Body certificate under the IVDD, per IVDR Article 110(3) third subparagraph:
    (a) 26 May 2025, for IVDs that would become Class D under the IVDR
    (b) 26 May 2026, for IVDs that would become Class C under the IVDR
    (c) 26 May 2027, for IVDs that would become Class B under the IVDR
    (d) 26 May 2027, for IVDs that would become Class A sterile under the IVDR.

In addition, as part of the EU Commission proposal to ease the bottleneck of the transition to the EU MDR and IVDR, the sell-off provisions in both the EU MDR and IVDR (i.e. basically one year after the end of each transitional period for upgrading CE-marking) are being removed, so that stocks of legacy devices at distributors can be sold out indefinitely, beyond the end of the corresponding transitional period.

With the most recent changes, legacy IVDs would transition to the new Regulation much earlier than non-IVDs. Further amendments to the transitional periods in the IVDR can be expected.

The below infographics summarize the new timelines under the EU MDR and IVDR:

Expired certificates

In principle, legacy devices with a Notified Body certificate can no longer be placed on the market if such certificate has expired. The manufacturer should have taken the necessary measures to ensure a timely transition to the EU MDR or IVDR, as applicable. In practice, the shortage and low capacity at Notified Bodies that was resulting in far too long and unpredictable timelines and generating a “certification gap” for some manufacturers, has led to changes in the initial requirements.

To prevent major disruption in medical device supply in Europe, several measures are being taken to speed up certification, particularly under the EU MDR, which is the most impending. Among these, MDCG_2022-18, describes the desired approach to ensure a common application of EU MDR Article 97 across competent authorities regarding expired Notified Body certificates under the MDD. Article 97 allows extraordinary and temporary authorization of non-compliant devices by the competent authority of a given EU Member State. The derogation should not exceed 12 months, unless duly justified. This document is to be read in conjunction with the EU Commission’s proposal to postpone the transitional provisions in the EU MDR explained above. It represents an addition to other similar EU measures published in 2022, i.e. MDCG 2022-17 on hybrid audits, MDCG 2022-15 on surveillance of transition provisions for IVDR, and MDCG 2022-14 on the transition to the EU MDR and IVDR.

Furthermore, the new amending Regulation 2023/0005 (COD) that extends the initial transitional period under certain conditions also allows for already AIMDD and MDD expired certificates to be considered valid again and until the end of the new transitional periods described above if either:

• a written agreement has already been signed with the Notified Body for the MDR transition, or
• a competent authority has granted a derogation under EU MDR Article 59(1), or
• a competent authority has required the manufacturer to proceed with the applicable EU MDR conformity assessment procedure, per EU MDR Article 97(1).

This newly granted extension of validity means that the “certification gap” would be allowed to last longer than the 12 months suggested in MDCG_2022-18. The reason is that MDCG 2022-18 was a temporary measure to bridge the time until the extension in transitional provisions is implemented in the European legislation, which will certainly be happening before competent authorities start working under MDCG 2022-18.

What EU MDR or IVDR requirements apply to legacy devices? 

EU MDR and IVDR provisions considered to apply to legacy devices are those detailed in the corresponding transitional provisions and are further detailed in guidance documents MDCG 2021-25 (concerning the EU MDR) and MDCG 2022-8 (concerning the IVDR), which include useful tables for the most relevant articles. In brief, duties that apply to legacy devices are those relative to post-market surveillance, market surveillance (i.e. deployed by the national competent authorities), vigilance, as well as registration of economic operators and devices.

All devices on the market are required to fulfill state-of-the-art requirements by securing compliance with all applicable standards and regulations.

Post-market surveillance and Vigilance

The most significant requirement for legacy devices is probably the post market surveillance requirements that apply. To be compliant with MDR/IVDR post market surveillance requires a systematic and proactive collection of data on the safety and performance of the device. EU MDR and IVDR also requires regular updates to the Periodic Safety Update Report.

*  However, there is no requirement for a full revision of the technical documentation in accordance with Annexes II and III.

Note that for “old devices”, as described under When does a CE-marked device (medical device or IVD) qualify as legacy device? above, serious incident reporting under the EU MDR or IVDR applies. Such reporting would entail a specific EUDAMED registration of the old device manufacturer, as detailed in question # 5 of guidance document MDCG 2021-13.

Registration of economic operators and devices

Manufacturers of legacy devices must register as actors in EUDAMED within 18 months of the EU MDR date of application (or, if EUDAMED is not fully functional before the date of application, 24 months after the date of publication of the notice referred to in EU MDR Article 24.3).

Legacy devices must also be registered in EUDAMED, as described in guidance document MDCG 2019-5. If these devices do not have a Basic UDI-DI or an UDI-DI they must have EUDAMED DI (instead of the Basic UDI-DI) and EUDAMED ID (instead of the UDI-DI). If these devices are then transitioned to EU MDR or IVDR CE-marking, linkages should be created between the respective registrations.

Related obligations of economic operators

EU MDR or IVDR requirements that are not related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices should in principle not apply to economic operators in respect to legacy devices. Within this context, guidance documents MDCG 2021-25 (concerning the EU MDR) and MDCG 2022-8 (concerning the IVDR) consider that related provisions in chapters covering the duties of economic operators should be considered to apply, namely:

• for manufacturers under the EU MDR: Article 10(10) and Article 10(12) through 10(15);
• for manufacturers under IVDR: Article 10(9) and Article 10(11) through 10(14);
• for authorised representatives: Article 11(3)(c) through (g);
• for importers: Article 13(2) 2nd subparagraph, Article 13(4), Article 13(6) through 13(8), and Article 13(10); 
• for distributors: Article 14(2) last subparagraph, and Article 14(4) through (6).

To be compliant with MDR/IVDR post market surveillance requires a systematic and proactive collection of data on the safety and performance of the device.

Do legacy device manufacturers need a PRRC?

The Person Responsible for Regulatory Compliance (PRRC) is a new requirement introduced in Article 15 of the EU MDR and IVDR. If you want to learn more about the PRRC role, please read The role of a PRRC under the MDR, which can also be extrapolated to the IVDR. 

Article 15 is not listed as part of EU MDR and IVDR transitional provisions applying to legacy devices. This is further confirmed in guidance documents MDCG 2021-25 (concerning the EU MDR) and MDCG 2022-8 (concerning the IVDR), where Article 15 of the corresponding regulation is cited as an example of provisions that do not apply to legacy devices.

When are Procedure Packs and Systems considered “legacy”?

Systems and procedure packs are considered legacy devices when they consist only of legacy devices and if a Statement per MDD Article 12 has been drawn up for them prior to 26 May 2021.

Once a component of the system or procedure pack transitions to CE-marking under the EU MDR or IVDR, the entire system or procedure pack loses its legacy status. However, any legacy devices included within a EU MDR system or procedure pack are covered by the transitional provisions of EU MDR Article 120(3) or IVDR Article 110(3), as applicable.

What specifically needs to be considered for legacy devices in Switzerland?

Switzerland is considered a third country to the effects of the EU MDR since 26 May 2021 and of the IVDR since 26 May 2022. Swiss legislation was adapted accordingly but it recognizes CE-marking per the EU MDR under the Swiss Medical Device Ordinance (MedDO, SR 812.213), and per the IVDR, under the Swiss In-vitro Diagnostic Ordinance (IvDO, SR 812.219).

As such, “legacy devices” and “old devices” have the same meaning and implications as under the EU MDR and IVDR. Because Swiss legislation basically points out the corresponding provisions in the EU MDR and IVDR, the recent updates to extend their transitional provisions will have to be carried over into the MedDO and IvDO, respectively.

In a nutshell, the requirements for legacy devices are the same in Switzerland as in the EU. However, because Switzerland is now a third country, all legacy devices from manufactures based outside Switzerland need a Swiss Authorised Representative, which is a new economic operator role instated since 26 May 2021 for non-IVDs and 26 May 2022 for IVDs. In addition, any Swiss entity bringing devices from abroad into Switzerland and further supplying them within the country becomes de facto Swiss importers and endorse new duties under the MedDO and IvDO. These requirements apply regardless of the legacy status or transitional stage of the device.

Swissmedic published in January 2023 an Info Sheet regarding the application of MDCG 2022-18 for expired certificates in Switzerland, where they indicate that the  written communication issued by a competent authority under Article 97 is accepted as evidence that an evaluation according to MDCG_2022-18 has been conducted and that a period to re-establish conformity has been officially granted, and a similar/further evaluation is not necessary in Switzerland. For foreign manufacturers, Swissmedic places the onus of verification that the communication has been issued on the Swiss Authorized Representative. Where no written communication has been issued by a competent authority and unless extended transitional provisions for expired certificates are already implemented in the EU, the Swiss Authorized Representative would have to notify the “certification gap” to Swissmedic, who would evaluate the request under MDCG_2022-18 and issue a related communication.

For more details on the economic operator roles in Switzerland, read these blog articles: Swiss authorised representatives for medical device manufacturers and Swiss medical device importers – regulatory requirements.

How Decomplix can help

Decomplix offers consultancy services in all regulatory and quality assurance matters relative to medical devices, with particular focus on the Swiss market and CE marking. We have in-house experts and a network of first-in-class partners. We can support your company in fulfilling all the requirements of under the EU MDR or IVDR and ensure compliance in the most efficient manner. If you wish to discuss your needs with us, please contact us for a non-binding CE marking quote.

In addition, we offer Swiss Authorised Representative services under both the MedDO and the IvDO, and already represent numerous foreign manufacturers. Our services include instructions and checklists for your understanding of the applicable requirements. If you are interested in Decomplix’ Swiss Authorised Representative services, please contact us via this form and send us the relevant data mentioned there.

Further reading

• Is my product a medical device in Europe? How to determine if your product requires medical device CE marking
• How to obtain a CE mark for a medical device
• Class I medical device requirements for manufacturers under the EU MDR
• Guidance on medical device significant changes
• Swiss authorised representatives for medical device manufacturers