As the political process to finalize and implement the European Medical Device Regulations, it’s worth taking a look at what actually happened. Remember, this reform was triggered by international concerns about safety of higher risk implantables, in the wake of the PIP breast implant scandal, as well as some high profile post market failures of other implants including metal on metal hip joints.
The response has certainly been to strengthen the European device regulation. But a closer look shows that this reform is more about governance and rigour than fundamental changes in approaches.
So what’s actually changed? The widespread debate and public concern about medical device safety really boiled down to two things:
- Is there adequate clinical evaluation of devices, especially newer high risk implantables?
- Are the assessment organisations, Europe’s Notified Bodies consistent and up to the job?
The new regulations address these concerns in two really quite simple ways.
First there’s a real shake up of the arrangements for the oversight of Notified Bodies. The objective requirements for competence, staffing, training and accreditation have been substantially strengthened. The whole process has been centralized. Gone are the days when every member state anointed its own Notified Bodies (with the inevitable variability in rigour and oversight). Now the accreditation process involves participation from at least two Competent Authorities – the national body overseeing the Notified Body plus a Competent Authority form another member state, as well as direct participation from the European Commission. Essentially a more transparent and objective process with some more checks and balances. And there’s no grandfathering provisions. All Notified Bodies are required to be re-certified from the ground up. The result is likely to be a substantial reduction in the number of Notified Bodies, from the peak of more than 8o to perhaps as few as 20. Those that remain will be bigger, better resourced and much more rigorously supervised.
As for clinical evidence, the Europeans have had several attempts at beefing up clinical requirements. The Directives have always required clinical evaluation of all devices. However the original 1993 MDD set these requirements out in a couple of rather ambiguous sentences which weer widely interpreted as not really being important for anything but the highest risk devices. The 2007 revision added several paragraphs of much more specific language and the transposition to the current regulations has gone further still, making it clear that well documented clinical evaluations are required across the board and for the highest risk devices, direct clinical trials will be the norm, unless there’s strong justification otherwise.
And that’s it.
There are a number of smaller adjustments (most notably classification rules have been tweaked to reflect some new technologies and refinements in knowledge of of risks). But the basic structure of regulation is otherwise unchanged. Conformity Assessment by third parties, Standards based technical requirements, a core application of of risk management to design and production, all of this is essentially the same.
The big changes are all about governance – about ensuring integrity of the assessment system and oversight of the assessors. Apart form the clear direction on expectations for clinical evaluation, everything else is pretty much business as usual.
PS: IVDs are different…
Of course this applies to Medical Devices only (the old MDD and AIMD have been merged into a single Medical Device Regulation). Things are somewhat different for In Vitro Diagnostics, where there are some truly seismic changes planned. Europe has considerably more liberal in regulation of IVDs compared to all the other major jurisdictions. The new IVD regulations make one fundamental, but far reaching change, by adopting a new classification system based on the GHTF rules. Such systems have been in palace in Canada and Australia for many years. Other markets such as Japan, US and China also have far more conservative classification systems than Europe, leading to far more IVDs requiring detailed regulatory oversight. The new regulations in Europe will see a situation where most IVDs will be regulated at Class B or higher in the 4-tier ABCD classification system. This reverses the current situation where most IVDs are unclassified and marketed based on self declaration. Expect a shake out in the market as the substantially stiffer regulations drive out the more marginal products.
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