Channel 4’s Dispatches programme on medical implants did not show how European medical device regulation is changing. Trevor Lewis argues that the medical devices directives are a work in progress, and that following the recent revision of directives, industry needs to be aware of their impending recast – which will have long-lasting and potentially fundamental effects.
If the regulatory system in Europe is to improve, a number of factors are needed. There has to be a mindset among all manufacturers to fully comply with or exceed the essential requirements of the directives. There is a need for more clinical investigations (both pre- and post-market), especially for higher-risk devices; and for greater transparency about the classification and presence on the market of all devices, especially higher-risk ones. The regulations should be enforced in an appropriate and proportionate way, with due regard to economic cost and the public health interest. Finally, all medtech industry representatives and other stakeholders need to work at improving the medical device directives, including the In Vitro Diagnostics Directive (IVDD).
Not the whole story
So there is work to do to make the medical directives fulfil their intended purpose – but Channel 4’s emotive The Truth About Going Under the Knife missed out the numerous actions currently in train to improve this situation, both in Europe and beyond. The programme’s major omissions are worth noting.
There was no significant discussion of the extensive pre-clinical tests undertaken by responsible implant manufacturers, such as finite element analysis, tribology testing, accelerated life testing, destructive testing, non-destructive testing, precision measurements, biocompatibility, toxicology and animal work.
It was not mentioned that the products cited in the programme were all placed on the market before the mandatory implementation of Directive 2007/47/EC on 21 March 2010 that revised the main device directives. There was no substantive mention or discussion of this recent revision, which:
• demands better compliance with the essential requirements (ERs)
• demands more clinical investigations for all products, except where their omission can be scientifically justified
• demands more transparency for higher-risk products, especially with regulators and in regard to product vigilance measures including recalls
• demands more scrutiny by competent authorities when biologics, medicines or human or animal tissues are incorporated into medical devices
• has generally increased the expectations that competent authorities (CAs) and notified bodies (NBs) have of manufacturers, especially in design and post-market surveillance activities
• has led CAs to demand improved performance and standards from NBs.
There was also no substantive mention or discussion of the current fundamental review of the directives known as the Recast. The Recast reinforces all the above points, and is encouraging a very wide consultation process. Suggestions made include using the Central Management Committee to provide better co-ordination and consistency across all EU regulators, both CAs and NBs.
Nor was there any substantive mention of the UK Bribery Act 2010 (though the programme questions ethical behaviour in the industry) or its international equivalents, or of industry codes of business practice such as the one long established by ABHI and Eucomed.
Dispatches did not refer to the Global Harmonisation Task Force (GHTF) move to become a regulator-only group in preparation to ensure its greater influence in the drafting of appropriate, proportionate and cost-effective medical regulations all around the world (many of which are based on the EU model).
The programme also did not acknowledge that other countries, such as those in MEDA (including Algeria, Egypt, Israel, Jordan, Lebanon, Morocco, Palestine, Syria, Saudi Arabia and Tunisia), have closely examined the directives for adoption. Turkey has already done so in preparing to enter the EU. These countries have all opted to adopt the EU system or a close equivalent.
Finally, there was no clear graphical representation to put the relatively small number of non-conforming products into the perspective of the huge number of devices that save lives and extend life in years, all over the world, without fault or concern.
Keeping a balance
Industry should not just believe that it will all come right in the end. ABHI and Eucomed have been telling their members for some time that there could be significant opposition to the Recast from a minority who think it does not go far enough. However, few predicted such a depth of interest in, and attack on the fundamentals of, the ‘New Approach’ directives from various quarters – including the recent articles in the British Medical Journal (BMJ) related to the Dispatches programme, the withdrawal of ISO 13485 for quality management by Sweden, and the objection by the European Commission to the use of ISO 14971 for risk management of medical devices as a harmonised standard.
All medical technology companies, especially SMEs, need to get involved in regulation and look after their own and their patients’ best interests. Some past directives, especially environmental ones, have changed in the last stages of their tortuous route through the European legislative process at the European Parliament and Council of Ministers. Companies must take nothing for granted and keep lobbying and putting their case forward until the final ink of the acceptable transposition document is very dry indeed.
Studies have shown the European system to be just as effective as the US Food and Drug Administration (FDA) approach. Indeed, the FDA recently mooted a ‘Class IIb’ approach with more emphasis on design scrutiny and use of clinical investigation as part of the pre-market clearance approach, mimicking the Class IIb approach in Europe. A recent US research study by Dr Josh Makower indicates that the EU system helps to deliver innovation to the market more efficiently than the US system – without compromising patient safety. Indeed, a substantial majority of companies surveyed in the US considered the EU regulatory experience much better than the US one.
Over-regulation denies patients the benefits of innovation – a situation much reported during the 1990s, when FDA Commissioner Dr David Kessler adopted a very tough stance. The Wilkerson Group report of June 1995, Forces Reshaping the Performance and Contribution of the US Medical Device Industry, is useful in this context. During the Kessler years, more than 100 products were denied to US citizens while being used safely in the EU and in other jurisdictions. The report provided useful statistics on the benefits of medical devices that we should keep in mind and promote to the general public.
The need for evolution
While claims that the Dispatches programme was unnecessarily alarmist are justified, it is still true that all stakeholders can do better – and indeed, the process of improving the system through the revision and Recast of the directives is well under way. The need is not for undue attention to Dispatches, but for focus on the vitally important Recast currently being discussed. We are clearly at an important time in the history of EU medical device legislation: the Recast will affect all devices and all patients for a long time to come – probably for 15 years, maybe for 20. It is not something the Commission will want to repeat in a hurry either – as was indicated by the Commission’s Director of Consumer Affairs, Jacqueline Minor, when she said “We don’t want to do it again” at a conference in Brussels earlier this year.
Some protagonists, including those writing for the BMJ, appear to be comfortable suggesting a pharmaceutical approach to medical device regulation – including the much vaunted (but often inappropriate) use of extensive double-blind randomised clinical trials as the central requirement for regulatory clearance. But a more measured and cautious approach is required in the best interests of patients, so they can receive cost-effective innovations in a timely manner. The highest-risk products must be subject to the most rigorous requirements and extensive clinical investigations – but this is actually a minority of devices, probably fewer than 10%. Most medical devices can be adequately tested with small-scale comparative clinical investigations and extensive pre-clinical testing and simulation. An extensive, comprehensive scientific literature search and report by an appropriately qualified person is always required.
The current position that the medical device regulatory world finds itself in causes me much concern. The focus should be on making the current system more productive and more rigorously used and enforced, not reinventing it. In Europe, while our medical device regulation is long-established, it can be improved. If we do not collectively evolve it further we risk losing a really good system – and doing so mainly because too many stakeholders (CAs, NBs and manufacturers alike) have not rigorously implemented them. We need a mix of sticks and carrots to improve the unfortunate perception that programmes like Despatches create in the minds of consumers.
Most important of all, if industry and regulators do not make good progress in the next few years then a worse alternative is very likely: that those currently demanding a prescriptive and draconian style of regulation, with excessive demands and requirements, will prevail.
Trevor Lewis is a medical device regulatory expert and Principal Consultant at Medical Device Consultancy (MDC).
Peter Ellingworth, Chief Executive of the Association of British Healthcare Industries (ABHI), commented:
“All patients should be able to feel confident that the medical devices used in their treatment are of the highest quality and safety. At the same time, patients need to be assured of timely access to medical technologies that can allow them to live healthy, productive lives.
“Europe is approaching almost 20 years of proven effectiveness of the Medical Devices Directive in regulating the safe introduction of new medical technology. ABHI has consistently supported the need for regulation of medical technology, and we argued in favour of the reforms currently proposed by the Commission and some Member States.
“The anticipated reforms address most of the criticisms raised by the BMJ and the TV programme Dispatches with regards to the regulatory framework: overall management and co-ordination of the system by Member States’ Competent Authorities, designation and control of Notified Bodies, availability of information and requirements for pre-market testing and post-market surveillance.”