MDD to MDR transition - a guide for legacy device manufacturers

While working on MDR submissions for new-to-market devices certainly brings challenges, MDD to MDR transition submissions are in many ways just as complex. It's easy to assume that gaining approval for a legacy device - the correct term for a device previously approved under MDD - will be straightforward, especially if it has been on the market for many years. However, this may not necessarily be the case.

Working with legacy device manufacturers from across the industry has enabled Mantra Systems to gain enormous experience in this key sector. In this article, we outline some key considerations when planning a transition from MDD to MDR.

1) 'Time on market' is not clinical evidence. It's well known that MDR has 'raised the bar' for clinical evidence requirements and legacy devices are not exempt. It may seem counterintuitive but while available evidence may have been sufficient under MDD, a reviewer may identify gaps under MDR. Specific examples include:

• Insufficient data on key patient populations. If a device is intended to be used on adults, children and neonates, evidence in all groups would be expected.
• Excessive granularity of indications. If the IFU, for example, identifies a range of specific target conditions, evidence of efficacy and safety in each condition will be required.

2) Your device is probably not 'Well Established Technology'. This concept - 'WET' for short - is widely misunderstood and a common reason for failed transition submissions. Intuitively, WET could reasonably be held to apply to any device that has been in market, unchanged, for a long time.

As stated in MDCG 2020-6 (an essential guide for all legacy device manufacturers), Article 61(6a and b) distinguishes between legacy devices (Article 61(6a)) which have been previously marketed under 93/42/EEC or 90/385/EEC and a specific subset of well-established technologies (WET) (Article 61(6b)).

Essentially, WET is relevant only to a subset of Class IIb or III devices that would otherwise need to be subject to a clinical investigation. WET offers an extension to the exemption to this need, as if a device is WET it doesn't necessarily need to be a legacy device to avoid a clinical investigation.

Article 61(6b) lists specific examples of devices likely to be WET, including "sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors". While there's no indication that this list is definitive or unchanging, if you aren't on the list then a WET claim is unlikely to be a successful route.

3) Claims of equivalence to multiple devices are likely to fail. We work with a large number of submissions where manufacturers have previously (successfully) claimed equivalence to multiple devices under MDD in order to 'frankenstein' an equivalence claim. In other words, they have 'borrowed' one feature from device A, another from device B and a further feature from device C and assembled them together to form an equivalence claim.

Unfortunately, this would not be acceptable under MDR. While it may be acceptable to claim equivalence to more than one device under MDR, it's a requirement that full equivalence is demonstrated to each equivalent device. 'Frankensteining' is specifically forbidden.

Accordingly, a successful transition is best served by finding a single equivalent device that is sufficiently similar in all technical, biological and clinical characteristics. If your MDD clinical evaluation was based on equivalence, seeking professional advice is highly recommended.

4) Your device may have been reclassified. Some devices may have been up-classified in MDR compared with MDD, which may have a significant impact on requirements for approval. For example, many software-as-a-medical-device products that were Class I under MDD will now be Class IIa under MDR.

This means that many manufacturers that were previously able to self-certify are now faced with the need to involve a Notified Body, increasing costs and timelines to approval.

Technical file considerations

Specific components of the technical file (and corresponding regulatory processes) will almost certainly need particular attention during MDD to MDR transition. These include:

• Clinical Evaluation. The principal reason for an unsuccessful transition application is an inadequate Clinical Evaluation. Our team has a 100% acceptance rate for CERs completed under MDR, including for transition submissions.
• Post-Market Surveillance. Pay careful attention to the requirements for PMS under MDR and examine existing systems and documentation in detail.
• Post-Market Clinical Follow-Up (PMCF). PMCF has gained prominence under MDR and will be in sharp focus. However, handled correctly, PMCF is a legitimate method for addressing gaps in clinical data, assuming that overall suitability for intended purpose can still be demonstrated.

Transitioning from MDD to MDR approval is something that all legacy manufacturers now need to be engaged in. As with everything, preparation is key. An honest assessment of likely barriers and deficiencies is a key part of this preparation.

If you are currently undergoing a transition from MDD to MDR and are seeking support or advice, contact our team at any time for a free and informal discussion.