What if I have concerns over clinical evidence requirements?
A degree of concern over the quantity and quality of available clinical evidence is almost universal. Notified Bodies will expect to see:
- Evidence of suitability for use across full scope of the Intended Purpose
- Clinical evidence of safety and performance specific to any special interest populations (children, neonates, pregnant women, etc)
- A demonstration of non-inferiority of subject device vs similar devices, according to a range of clinical outcome parameters.
From this, it can be seen that requirements for clinical evidence are both broad and specific, calling for a collaborative and problem-led approach during technical file development. The Clinical Evaluation requires particular care, with our highly specialised and experienced team being ideally positioned to navigate challenges around clinical evidence sufficiency.
On a majority of occasions, skillful handling enables Class IIa submissions to be progressed to approval on the basis of available evidence. With Class IIb submissions the Notified Bodies impose even greater scrutiny; despite this, our team has a superb record of maximising the return on available evidence and minimising delays to the eventual submission process should supplemental evidence be required.
The key to success is complete transparency and clear communication, features that are baked into the conduct of every project run through our Class IIa/IIb service.
If you have concerns over the sufficiency of existing clinical evidence for your devices and are looking for a genuine opinion, contact us for a free, friendly and no obligation discussion.
Can I claim equivalence under EU MDR?
The short answer is “yes”. While more burdensome than under MDD, equivalence is still a viable (and common) route under MDR.
Unlike the case of Class III devices, Class IIa/IIb device manufacturers do not need to establish a contract with the equivalent device manufacturer. However, it will be necessary to meet the test for “sufficient access to information relating to the equivalent device”.
A further change is the prevention of “Frankensteining”. Possible to an extent under MDD, this was the practice of borrowing partial elements of multiple equivalent devices, with the combined total of the borrowed elements forming the ‘equivalent device’. For Class IIa/IIb devices under MDR this practice will be entirely unsuccessful, meaning that legacy device manufacturers may need to re-think formerly successful conformity routes.
Our expert team will guide you through an equivalence claim every step of the way. For advice on the likelihood that equivalence will succeed, contact Shen or Will today for a free, professional opinion.
How do you approach legacy devices?
A common challenge relates to legacy devices that are highly established on the market but that have little to no published clinical data. In these cases, the regulations don’t offer the flexibility that might be preferred, posing difficulties that may initially seem to correlate with the length of time on the market.
An intelligent approach is required to ensure that approval of Class IIa/IIb legacy devices remains uninterrupted. During consulting project planning, the needs of each device are considered in detail during collaborative discussions between client, project team and service leaders. With potential problems highlighted from the beginning, solutions are developed proactively and in plentiful time, rather than reactively. It’s an approach that leverages the Class-specific experience of each project team.
Are there any specific considerations for software (SaMD) devices?
Although Software-as-a-medical-device (SaMD) can fall into any of the four risk classes under MDR Rule 11, the majority of such products will be Class IIa. As a result, challenges relating to Class IIa submissions in general also apply to SaMD, with additional specific considerations resulting from the transformability and malleability inherent in a software device.
Can a legacy device be a “Well-Established Technology” (WET)?
The term ‘well-established technology’ is a source of much confusion and is often mistakenly taken to mean “legacy device of long tenure”. This is tempting, since MDR Article 61 allows WET devices to be exempted from requirements for conformity to be supported by clinical evidence.
In fact, MDR Article 61(6b) contains a specific list of devices currently held to be WET, which includes:
“sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors”.
MDCG 2020-6 correctly adds that the term is not restricted to the devices listed in Article 61(6b), and that Article 61(8) explicitly states that the definition of WET may extend to devices “similar to [those] listed in Article 61(6b)”. However, in practical terms current practice limits successful WET claims to those listed in Article 61(6b), with devices not on the list almost certainly requiring a different route to conformity.
Class IIa/IIb consulting – summary
Overall, it can be seen that successful Class IIa and IIb submissions require dedicated expertise. The Mantra Systems Class IIa/IIb consulting service offers access to highly-specialised project teams combining cross-sector experience, regulatory expertise and clinically-trained professional medical writers. Under the leadership of Shen and Will and coupled with a 100% money back guarantee, your submission is in the very safest of hands.
