As we wait for a new legislation for Europe’s medical devices — whose implementation will be phased in from mid-2016 — Matthew Orman weighs up what the ongoing negotiations mean for safety, innovation and the future of the industry
Following the 2010 PIP scandal , the European Commission embarked in 2012 on a full regulatory overhaul of the medical devices industry . With the aim of guaranteeing high levels of safety and restoring public confidence in Europe, the Commission published two draft Regulations — one for medical devices and one for in vitro diagnostic medical devices,. After nearly four years of painstaking negotiation between the EU institutions, industry and Member States, the end is almost in sight — but what does the new framework mean for the sector — and the broader question of innovative technology in healthcare?
A binding regime
In its 2012 reforms, the Commission aimed to achieve a tightening up of the regulatory framework surrounding medical devices, rather than a complete revision. The major difference however, was that the new legislation will be in the form of regulations — which are directly enforceable in Member States — in contrast to the current regime, which is based on Directives. These, the Commission argued, had been inconsistently implemented in Member States, effecting both patient safety and the internal market.
The new regulations cover a wide range of products, from sticking plasters to hip replacements, pacemakers to laboratory tests for the assessment of medical interventions. They also opened up the policy to a host of other medical technologies — aesthetic devices, weight loss surgery and apps among them.
Four years of political negotiations are expected to reach a conclusion in the coming months. The European Council (Member States) has finalised its position, and last Autumn entered into Trilogue — informal talks with the other EU institutions, i.e. the European Parliament and European Commission — on the basis of which agreement on a final text will eventually be reached.
This is a process that has been beset by delays, but the Dutch Presidency (incumbent from January to June only) has said that the proposed legislation could be published in the middle of the year. After that, the Regulation on medical devices would be applicable three years after its entry into force, while a five-year period is proposed for the Regulation on in vitro diagnostic medical devices.
A line in the sand
As it currently stands (according to the Council text which is the basis for trilogue discussions), the proposed new regime will mean the following:
- Greater transparency for patients — in particular those taking part in clinical trials;
- Manufacturers and importers will have to register themselves and the devices they place on the EU market in a central database — the European databank on medical devices (Eudamed);
- Manufacturers of medical devices will have to fit their products with a unique device identification to ensure traceability;
- Reinforced rules governing clinical evaluation throughout the life of the device, including the introduction of the concept of a ‘sponsor’, as well as a new requirement for manufacturers to have a ‘qualified person’ responsible for regulatory compliance;
- New rules for the reprocessing of single-use medical devices to make them suitable for further use;
- The creation of an EU portal where manufacturers would have to report serious incidents and any corrective actions they have taken to reduce the risk of recurrence;
- A post-market surveillance system detailing manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market. These include annual periodic safety update reports (PSURs) — a step which brings medical devices into line with pharmaceutical reporting requirements;
- A tightening of the rules for the designation of notified bodies, the monitoring of their assessment activities by national competent authorities and cooperation between competent authorities. The new rules would also give notified bodies the right and duty to carry out spot checks in the form of unannounced factory inspections;
- Extension of the scope of medical device regulation to cosmetic/aesthetic devices (eg contact lenses or fat-removal devices), as well as ‘ingested products’;
- The introduction of a new expert group (the Medical Device Coordination Group), which will have the power to review and comment on Notified Body assessments of high-risk medical devices before the device is put on the market.
What happens next?
After the Council adopted its general approach in the July 2015 EPSCO meeting, European Council President Guntis Belēvičs called the move ‘a decisive step forward to improve patient safety and strengthen European competitiveness.’ The general consensus is that many of the Regulations’ critical issues have been resolved. However, some Member States and people in the industry continue to have their concerns, which are still being thrashed out — in particular surrounding:
The newly added ‘scrutiny’ mechanism
Medical devices and in vitro diagnostic medical devices aren’t currently subject to pre-market authorisation but undergo a conformity assessment to establish whether they meet applicable standards. Depending on the risk posed by a product, the assessment may involve a Notified Body.
The draft text proposes a secondary scrutiny process as an additional control mechanism to improve the overall quality of Notified Bodies — something the Devices industry considers to be an unnecessary duplication given that the text already contains other — arguably more robust — safety controls that will strengthen the patient safety net, ie by enhancing the quality and expertise of Notified Bodies.
The proposed regime, they argue, creates burdensome procedures leading to unnecessary delay in the availability of devices to patients, as well as legal uncertainty in what will only serve to adversely impact the innovation and growth of the medical device industry. Moreover, the proposed ‘scrutiny’ procedure comes too late in the process and is based on a random selection of products.
In vivo and in vitro testing
While most Member States agree that there is a need for laboratories to test the predictive powers of in vivo diagnostic medical devices, few consider the same need in the case of in vitro medical devices. Instead, they favour the establishment of expert panels with competence for certain groups of devices. MedTech Europe declared that the additional clinical evidence requirements put on IVDs had ‘unclear benefits for patients’.
The repurposing of medical devices
To reflect differences between Member States, the Council has amended the Commission proposal to enable countries that wish to allow the repurposing of medical devices to do so. In this instance (unsurprisingly), the industry opposes Council’s position, saying it will lead to a non-harmonised approach and a disparity in safety standards from one member state to the next. In addition, the Council has introduced three levels of patient safety depending on the entity who reprocesses the device (original manufacturer, commercial reprocessor or hospital reprocessor) — the industry is calling for a level playing field to ensure equal levels of safety for all products, regardless of who is the reprocessing entity.
The issues raised above might not be the only sticking points, however. Under the terms of the Trilogue, amendments made to the text by the European Parliament that were subsequently deleted by Member States can be re-introduced. For example, campaigners interested in European genetics research worry that the Parliament might want to beef up rules for in vitro diagnostic devices by inserting the need for mandatory genetic counselling to accompany every genetic test and insisting that tests can only be carried out by medical professionals.
As is so often the case with such policies, the challenge before legislators has been to balance device safety with the need to ensure prompt access to innovative new devices and to promote European economic competitiveness. Put bluntly, it is generally the European Parliament that favours a more interventionist, safety-first approach, while the European Council (Member States) prioritise economic arguments, light-touch regulation and the interests of manufacturers in their territories.
Even after the legislation has been adopted, the challenge of regulating this industry at a time of rapid medical and technological — as well as social change — goes on.
A case in point is the estimated 97,000 mhealth apps that are currently available on the market. As the EU’s eHealth Action Plan 2012–2020 acknowledged, mHealth blurs the distinction between traditional clinical care and self-administration of care and wellbeing.
The Council has tried to address this possible confusion by delineating between lifestyle and well-being apps. Specifically software for general purposes — even when used in a healthcare setting — or software intended for well-being application is not a medical device. However with more and more medical devices being implanted, controlled and monitored remotely by software in the hands of doctors and patients, this distinction may not stand the test of time — which raises a new challenge for the device industry.
Since this software — whether it is linked to a medical or ‘lifestyle’ device — is gathering data that has considerable economic value to those that have the licence to own and interpret it, it too must be regulated. The Commission has just published its proposals for a comprehensive reform of the data protection rules. The upshot is the introduction of a single pan-European to replace 1995’s data protection rules, which have been interpreted differently by different member states. ‘A single law will do away with the current fragmentation and costly administrative burdens, leading to savings for businesses of around €2.3 billion a year. The initiative will help reinforce consumer confidence in online services, providing a much-needed boost to growth, jobs and innovation in Europe,’ says the Commission.
Whatever the outcome of what has been a protracted, complex and occasionally frustrating adoption process, the new legislation will provide a host of new challenges for businesses as they look to undertake long-term strategic planning and make the necessary changes to their policies and procedures.
The question is, will the European Commission get the message, listen to industry and ensure a smooth regulatory transition. There’s no doubt the vision is there. In the words of Commission Vice President, Andrus Ansip: ‘To me, it seems obvious that we could make more and better use of information technology so that Europeans of every age can improve how they manage their health and quality of life… Healthcare in Europe lags a long way behind virtually every other sector in implementing IT. But it is also clear that IT applications can revolutionise and improve how we take care of ourselves.’
Originally published at medtechengine.com.