What are the requirements for a successful conversion from MDD to MDR?
Gaining legacy device approval under EU MDR needs careful planning and meticulous implementation. At a minimum, successful progression to MDR compliance requires:
- Comprehensive Gap Analysis of existing technical files vs MDR requirements
- Confirmation of device Risk Class against MDR Annex VIII Classification Rules
- Updated SOTA review to confirm safety & performance benchmarks against which device will be assessed
- A relevancy analysis of the GSPRs and appropriate evidence of conformity
- Review of Risk Management File to ensure alignment with MDR
- Re-formulation of and updates to Clinical Evaluation Plan and Report according to MDR Article 61 & Annex XIV Part A
- Allocation of a Basic UDI-DI
- Production of a PMCF Plan in alignment with MDR Annex XIV Part B.
An established presence on the market is not enough, in itself, to secure approval under MDR. Rather, legacy devices will be reviewed in line with new-to-market devices, including the need for clinical evidence to support safety and performance.
What are the MDD to MDR transition timelines?
Deadlines for gaining approval under MDR for legacy devices were extended by Regulation 2024/1860 to ensure continued availability of devices. This extension offered some respite for manufacturers but still imposes time pressure on ensuring full conformity with the MDR.
Different transition deadlines apply to different medical device classes:
- Class III custom-made implantable devices – 26th May 2026
- Class III devices and Class IIb implantables (non-WET) - 31st December 2027
- Non-implantable Class IIb, all Class IIa, Class Is and Class Im – 31st December 2028
During the transition period, legacy devices must continue to comply with the MDD 93/42/EC. In addition, they must now comply with the MDR’s market surveillance, post-market surveillance, vigilance, and device registration requirements.
Some key deadlines imposed by the amending Regulation have already passed. These are:
- Requirement to application for MDR certification and comply with MDR Quality Management System requirements (26th May 2024)
- Obligation to enter into a contract with a Notified Body (26th September 2024).
Our expert team can advise on the most appropriate next steps if you have missed any of the above deadlines. Contact us for a free and confidential discussion.
What are the common challenges faced by legacy device manufacturers?
A common challenge relates to understanding that a history on the market is not itself sufficient to meet MDR requirements. This can understandably be a source of frustration for manufacturers who, with some justification, may point to a long commercial history as evidence that healthcare professionals view the product as safe and effective. However, the MDR introduced more stringent requirements for clinical evidence across all devices, including those previously certified under MDD 93/42/EC. Because a strategic approach may be required to overcome this barrier, working with a transition consultant can help alleviate difficulties relating to available data without requiring a clinical study.
A compounding difficulty can arise directly from longevity on the market. Many legacy devices have become so highly established that there is no incentive to publish research on their safety and performance. This poses difficulties in the light of MDR requirements calling for direct evidence of suitability for intended purpose and alignment with safety and performance objectives. Again, a strategic approach making best use of available data and possible conformity routes is often required to ensure a smooth transition to MDR approval.
Meeting resource requirements needed to move through MDR approval processes is a further significant challenge. This is such an issue that some manufacturers have chosen to decommission some of their portfolio, where cost-benefit calculations don’t support the navigation of MDR approval.
Can I still claim equivalence under MDR?
Yes, equivalence remains a valid route to conformity for many devices under MDR. However, there are some key differences between MDD and MDR equivalence that must be understood to avoid transition challenges.
- Claiming equivalence to more than one device is far less likely to succeed under MDR
- ‘Frankensteining’ - the practice of borrowing aspects of multiple devices and pointing to the assembled ‘whole’ as an equivalent device – is not permitted under MDR
- For Class III devices, if the equivalent device is made by a body other than the subject device manufacturer, a contract must be in place granting full access to the equivalent device technical files. This usually excludes equivalence on a practical level.
MDCG 2020-5 sets out a detailed interpretation of MDR equivalence rules. This, alongside the MDR as a primary source, should be understood in detail by all legacy device manufacturers seeking to utilise this conformity route.
Remember also that merely evidencing equivalence is not sufficient to ensure approval. The subject and equivalent device together must have enough clinical evidence to support safety, performance, suitability for intended purpose and a favourable benefit-risk profile.
- MDCG 2020-6 is a detailed guideline published by the Medical Device Commissioning Group with a specific focus on legacy devices under MDR. It is essential reading for all manufacturers overseeing MDD to MDR transition for their devices.
- MDCG 2021-25 rev. 1 provides specific guidance on transitional arrangements for legacy devices approved under the Medical Device Directive before 26th May 2021.
- Management of Legacy Devices – MDR EUDAMED is a European Commission Publication that sets out how Legacy Devices will be identified in EUDAMED, along with methods by which different Unique Device Identifiers for Legacy Devices will be generated/assigned.
