Medical devices: new isn't always better

The Bill seeks to remove patients' rights to redress if a doctor provides treatment that no other responsible body of doctors would give.

Challengers of the Bill have concerns about the future of patient safety, yet doctors can currently safely and rapidly innovate if necessary, as has been demonstrated by recent efforts to produce a treatment for the Ebola virus currently devastating much of West Africa.

Those opposing the Bill have concerns about the future of patient safety.

In the field of medical devices, similar fears persist concerning the lack of appropriate regulations which stand between manufacturer and patient: manufacturers across Europe are still able to fast-track products to market with scant or non-existent clinical evidence in support of them, on the basis of 'substantially equivalent' or predicate devices. This enables manufacturers to innovate incrementally, making reportedly minor changes to the design and materials while the established heritage of the new product.

The consequences of this regulatory system are writ large in the persistent, and clinically devastating, failures of hip implants which have been subject to international product recalls from 2010 onwards.

In the wake of recent scandals, concerning faulty breast and hip implants, new legislation in the form of the European Medical Device Regulation, is now on its way.

The motivation for this new legislation is that devices cleared for the EU should be subject to greater and more consistent pre-market scrutiny. The existing clearance structure, which relies on a network of delegated notified bodies within each member state, has resulted in a system whereby unscrupulous manufacturers can still go 'clearance shopping' - ie seek clearance for their product through 'soft touch' notified bodies within certain member states.

With deference to anti-federalist sensibilities across the EU, the reform proposals that have emerged stop well short of recommending a US-style, pan-state regulatory model, as per the Food and Drug Administration (FDA).

The FDA has many detractors and yet the US regulator has had some conspicuous success, from Thalidomide to the ASR resurfacing hip device, in protecting US consumers where its EU counterparts have failed. However, the closest that the EU legislators have dared to go in their proposal document is to mandate the creation of a Medical Devices Coordination Group (MDCG), operating at a supra-state level which is intended to monitor applications being handled by the notified bodies on an ad-hoc basis: This group will have the power to request additional information from a manufacturer before a notified body can provide final clearance for a product. In addition, MEPs have insisted on the creation of an Assessment Committee for Medical Devices (ACMD). If implemented, this Committee would be asked to opine exceptionally on products that are identified by the MDCG as 'high risk', further scrutinizing the design files made available by the manufacturer.

Whether these innovations will ensure greater rigour among notified bodies remains to be seen. The fact that this additional level of scrutiny will only routinely apply to devices identified as 'high risk' relies on the ability of the bodies, and the ad hoc powers of the MDCG, to identify as products. This will be particularly challenging in an industry where device development has been self-consciously incremental, with manufacturers down-playing device novelty when seeking clearance and emphasising the established market legacy of novel devices.

Many clinicians and academics had hoped that the final text of the new regulation would include key practical innovations such as the requirement that all class III, or 'high-risk' devices, are subject to 'phased introduction', ie controlled rather than a mass market release. Such phased introduction is recognised by many as the best practical solution to the ethical conundrum of facilitating exceptional early access to innovative products whilst safeguarding the patient community as a whole.

As it stands, the final text of the Medical Device Regulations includes no such innovation.

As we move into a new year, the European Medical Device Regulation remains a working document, and will not come into force until 2017. However, it seems increasingly unlikely that the regulation will have the transformational effect many advocates for patient safety have hoped for, a fact which underscores the reality that,as with the devices themselves, 'new' in the field of medical devices should not always be interpreted as 'better'.

Sarah Moore is a solicitor at Leigh Day

www.leighday.co.uk