There are some who are claiming that the EU Commission’s formal objection to eleven standards raised at the end of last year shows that the ‘New Approach’ has shortcomings and that the whole system is ripe for overhaul. I would argue far from it. The New Approach is a very clever system of product regulation, directing resources to where they are most needed while allowing manufacturers to innovate and permitting innovative medical devices to get to patients sooner and with no decrease in safety. The New Approach has shown itself to be a very flexible and efficient method of ensuring safe products reach the patient. What the EU Commission ‘formal objection’ does illustrate is a system that is ‘growing up’ and having to work with more globalised and integrated world economies.
The concept of the ‘New Approach’ was, and still is, revolutionary. All medical devices, from the lowly Class 1 tongue depressor, to the most sophisticated Class III heart valve, and everything in between, has to be safe and meet the ‘Essential Requirements’ of the Medical Device Directive. Mapped on top of this is a risk-based oversight from the authorities, thus ensuring safety and the most efficient use of government resources. Standards currently form the backbone of the system and although voluntary, provide a foundation on which manufacturers can design and manufacture their devices. Harmonised standards provide a convenient route to demonstrating compliance with the regulations.
But we shouldn’t let convenience slip into complacence. One of the interesting things to come out of the formal objection is the almost complete indifference by some manufacturers to whether standards are harmonised or not. The rationale is interesting. ‘Regulatorily sophisticated’ manufacturers use standards as a road-map to generating the safety data necessary to meet the Essential Requirements. They understand that the target is the Essential Requirements and not standards. They point out that standards can promote a ‘tick box’ approach to device safety and in fact divert manufacturers away from actually thinking properly about the safety and performance of their devices. Standards become the target rather than the way.
Paradoxically therefore, following standards alone, without any regard to the Essential Requirements, may actually mean that a manufacturer risks not completely addressing all elements of a particular safety requirement in the Essential Requirements. Consequently, as far as these ‘Regulatorily sophisticated’ manufacturers are concerned, if the standards in question are deharmonised they would not necessarily see it as a totally negative outcome, some, ironically, may even welcome it as a way of refocusing everyone on the requirements themselves.
With greater globalisation, standards are increasingly being drafted at the global level and are therefore a consensus of a large number of global players. This in itself represents challenges to the ‘New Approach’ system. If standards were written at European level it would be easy to ensure they match the requirements of EU legislation. However if standards are taken from the global arena, they will not have been written with European legislation as the primary consideration. Notwithstanding the efforts of the Global Harmonization Task Force (GHTF), with the rise of the ‘BRIC’ countries this will almost certainly become the case, at least in the short/medium term.
This could therefore mean there will be increasing discrepancies between what European legislation requires and what (global) standards actually provide. Perhaps, therefore, the time has come to redraft and redefine the interlinkages between standards and EU legislation.
The Medical Device Directive has shown itself to be an efficient and effective method of providing safe medical devices and I know of few, if any, manufacturers who disagree with its basic methodology. Standards form an essential basis from which manufacturers can demonstrate compliance with legislation. Standards should not be the end, but merely the means to an end. Re-evaluating exactly how standards are used in support of European safety requirements would therefore seem necessary if the New Approach is to develop and grow further in an increasingly globalised world. A less rigid reliance on standards could be an antidote to the overzealous reliance on standards by some Notified Bodies. A more pragmatic approach to the ‘harmonisation’ process, with clear, simple technical and legal checks, could just mean more innovation and that safety is actually increased.
– Andy Vaughan, Association of British Healthcare Industries (ABHI) Standards Consultant
