New European Medical Devices Regulations: Implications for Innovation, Brexit and i4

The Medical Devices Directives are European laws that essentially govern the manufacture and sale of all medical devices - ranging from dental fillings to hip replacements and pacemakers - in the European Economic Area.  These have recently been overhauled for a variety of reasons, including better harmonisation with the regulatory environment for pharmaceuticals as well as in response to a number of disasters I have written about before (such as metal-on-metal hip replacements and the PIP breast implant scandal). No blog could be sufficiently long and detailed to cover the details of the new rules, but some key features of note are:

• The regulations are more comprehensive and demanding in almost every way, meaning more details are recorded (from the supply chain, placement in the patient, and at the point of failure). The level of detail is greater, and the depth and rigour of the quality assurance processes being applied has been increased substantially.
• With resect to traceability, the vast majority of medical devices will now have a unique identifier so that they can be followed on a supply chain "time line" from manufacturer to patient to failure.  Some devices will most likely be exempt, for example dental materials, but for the first time so-called cosmetic devices (such as breast implants) will be captured by the new regulations.
• Patients will benefit from an "implant card" that describes their new device, the risks, and alternatives, all in theory written in lay terms.
• Post-market surveillance will be strengthened substantially, and communication between different European countries will be greatly improved.
• Manufacturers will need to employ and identify a named competent person to oversee and take personal responsibility for the quality assurance of their products and compliance with the Medical Devices regulations.

While many campaigners will see these changes as good and probably long overdue, there will inevitably be some more negative consequences.  Most obviously, tougher regulations will introduce new costs into the manufacturing process and the healthcare system, and these costs will ultimately need to be covered (with the most simple mechanism being a price rise that we will all pay for in one way or another).  There are, however, a number of impacts that are more difficult to predict.  For example, the scale and complexity of the regulations means that smaller companies might struggle to comply - especially with innovative products - and instead it is likely the new regulations will on balance favour the larger multinationals who have the critical mass and expertise to manage these changes internally.  This may not appear as a "negative" to the casual reader, but there is evidence that a proportion of innovation that is destined to be valuable for patients (in terms of reduced pain or enhanced quality of life) takes place in smaller companies (so-called SMEs).  I am therefore concerned that some aspects of the new regulations could work against the product innovations we all need, and patients will suffer and/or have shortened lives as a result. This may though be a price worth paying for more responsible innovation, especially in sectors such as regenerative medicine where there is an emerging narrative suggesting that experimentation on patients without proper informed consent may have occurred.

There are countless examples of unmet clinical needs. Just one increasing challenge is device-associated deep bone infection.  The costs associated with this problem are huge, the pain and misery for the patients is very real, and the consequences for society are serious.  There are many promising solutions that could address this challenge being worked on throughout Europe (including in my laboratories), and the most promising technologies are already being passed to companies for commercial assessment. There is a real risk that, at the time of greatest clinical need, we will raise the regulatory barrier so high that their development ceases to be clinically or commercially viable.

Not all aspects of the new regulations are negative; indeed I agree that the system needed a major overhaul, and the majority of changes are affordable and in the public interest. The possibility of small businesses failing and innovation being curtailed is a risk rather than a certainty, but one we should be aware of.  Of the many positive aspects, the most exciting is arguably the traceability of medical devices throughout the supply chain to the patient. Coupled to "i4"(the 4th industrial revolution where the level of detail and control of the manufacturing processes is being transformed),  there is an opportunity here to gain unparalleled insights into the factors that determine success (or failure) of almost every medical device placed in a person.

There is though one final dark cloud looming ... Brexit!  In my opinion, access to the European market for UK medical devices manufacturers is essential and non-negotiable. My reasoning is based primarily the huge value of this sector to the UK economy, and the specific value of European exports to most of our businesses. This will mean full UK compliance with the new regulations, but without a seat at the table to discuss their modification or improvement during this long but critical implementation phase.  Some Brexit supporters seem unable to grasp the potential social and economic costs of a failure to negotiate a sound departure from the EU, and their first instinct is to be pleased to shake off the shackles of European laws, even laws designed to promote trade while protecting citizens. The changes to the Medical Devices Directives will have a real impact that should include safer materials and technologies for patients, but could include the loss of businesses and jobs in the UK if we do not manage their implementation carefully.