It’s hard to believe it’s happened, but here we are. The UK will now extricate itself from the machinery of the EU to an extent that feels absolutely miles off being determined. We might end up with tariffs on exports and imports, hideously increased amounts of paperwork to ship our exhibition goods to France, a currency imbalance that kills imports completely (or indeed exports, but that’s rather more unlikely). We might have lit a firework we can’t now put out, which will either result in the dismantling of the EU or the strengthening in the resolve of its remaining club members. Personally, as a British citizen I’m distraught at the so-called will of the British people, and pretty darned angry that resorting to a referendum, something so important for our stability, prosperity and our place in the world, was tossed in as a gambling chip to keep the Tory right wing happy and the population thinking what a good guy our leader was in the run-up to election day. Mr Cameron will be regretting it now, but his regret will extend to a slightly earlier departure from post than was due to be the case, coupled with what might not look like a great chapter in the history books. It’s a legacy he didn’t want, but by putting the house on the result, and losing, it’s what he’s got. We all, meanwhile have to deal with the consequences which, for the Medical Device industries is a big deal with currently little certainty surrounding it. The decision could cost us dear and leave us with the paradox of more red tape than the pile we were seemingly so keen to leave behind.
Back to the medical device industry then, I recently penned a short update on the latest amendments to the European Medical Devices Directive(MDD), the rule book to which EU member states will demand adherence from 2019 and one that has been in preparation since 2012. It was spawned in the aftermath of several notable device-related catastrophes, ranging from endemic problems with hip prostheses comprising metal-on-metal surfaces, breast implants found to be filled with sofa-stuffing-grade silicone and Implantable Cardioverter Defibrillator leads that had a tendency to escape from their insulating coverings.
Being an industry insider it was almost comical at the time to watch UK parliamentary committees blustering about the extant regulatory slackness, clearly having only just found out that the EU Medical Device Directive (of 1993!) had a few yawning chasms in it that had allowed companies to fill the market with so many “dangerous” devices. And here, perhaps is just one more (too late now) point about our exit from the EU. Yes, it’s bureaucratic, but surely there’s some logic in having one big committee of “non-elected Eurocrats” (for which read Civil Servants by the way), doing the job once for all of us rather than 27 times in 27 countries, all of which have their own “sovereignty” which can so easily translate into barriers to entry. Watching several hours of a UK parliamentary select committee learning on the job from a host of independent experts was illuminating to the extent that one couldn’t help thinking “surely you should have known a bit more about this stuff.”
So my first point is made: A rule book written by one pool of experts in Europe, while it might take 9 years, will work and patently does work, because it reads well and enjoys an ongoing review process that makes it read better and better as they iron out the wrinkles. In what possible way could a UK equivalent have improved on this, and in what world do we think that the other Member States would agree with that assertion?
We are, however, where we are, thank goodness, because the new rules are edging towards the finishing line. If we assume the UK will abide by the new EU Device Regulations, then fortunately the rule book has been written, so all we have to argue about is whether it will apply to us and in what form will compliance be assessed. Job done then? Well, er, no. Not quite. While we’d be insane to diverge from the rule book, the EU might just want a few ounces of flesh before saying well done chaps, carry on. Because what the EU exit might just mean is that we can’t simply pop a CE mark on our products just because we follow the same rule book. Here’s why: By affixing a CE mark to a product a company is saying it complies with the EU Medical Devices Directive. That’s fine so far, because the regulatory burden hasn’t changed. EU rules exist and we’ve complied. Except that we’re not automatically allowed in unless, like other non-EU device companies, we have an appointed Authorised Representative within an EU Member State. Oh dear, I can sense creeping bureaucratic hurdles popping up already.
Notified Bodies
Then there’s the good old Notified Body (or good “new” Notified body as the new regs confer them with significantly more power, greater obligations, greater responsibility and a raft of compliance measures of their own to enjoy). While inside the EU, manufacturers can appoint a Notified Body from the UK to pop up the M1 once a year and do the necessary auditing for a couple of days to tick that Quality Systems compliance box and follow-up any outstanding work on devices that require Notifed Body approval. Here again, to think that the EU will simply accept a UK Notified Body, effectively operating under the flag of the EU, while being in a non-EU state is not a given. After all, nothing’s a given. UK-based Notified Bodies are already issuing comforting statements about business as usual for a couple of years, followed by the expectation that well recognized existing mechanisms in place for non-EU countries to participate as EU Notified Bodies will endure. In a statement on its website BSI cites as examples the “designated organizations in Norway (under EEA recognition), Switzerland and Australia (through Mutual Recognition Agreements), all recognized as Notified Bodies for the purposes of the relevant EU legislation.”
Indeed LRQA has issued similarly comforting words.
Let’s hope they’re right to feel so relaxed, but I suspect there’s a bit of panic under the veneer of fine words. There may be hoops to jump through that don’t exist today. This isn’t a simple matter and it will all end up adding to the financial burden of regulatory compliance that was accelerating long before we sleepwalked to the Brexit last Thursday.
And there’s more
More thorns exist in the side of the idea that cross-border collaboration is a given. For Class III devices the new regulations require “expert panel” involvement. Does this mean an expert panel comprised of EU Member state experts or could UK participants be involved? Then there’s the whole matter of how to manage and control clinical trials performed in Europe under the auspices of companies based outside the EU which require data protection reps to be appointed in each Member state in which the trial is occurring. That’s the rule now, so it’s tough to imagine it softening up for the UK.
And what about the new requirement for Unique Device Identification and entry onto a European device database? How will that work? The notion that UK companies will be plugging data into an EU database and benefitting from the useful, nay vital output from that very database, is only that… a notion. I’ll admit I haven’t the first clue about how such a database will work even within the EU, but I can see even less how it works for those of us who were so keen to go it alone.
It’ll all be fine… unless we mess it up
What might of course happen is that our 2 year, post-Article 50 period sees both sides meeting over a mutually agreed, suitably advantageous two-way street with a harmonised directive and free movement of Notified Bodies as at present. But while that remains a possibility, even if it does happen, the bureaucratic workload simply has to increase if UK based manufacturers are to be given access to the EU market. That’s without all the arguments about what constitutes compliance, and even if we do end up as signatory members of the European Economic Area(EEA). And by the way, if we did that, and if the EU decided to rewrite the MDD again, we’d have no input and little choice but to comply… so much for sovereignty. Already the rent-a-controversy UKIPpers are saying we’d be better off without the Medical Devices Directive, citing its demands for wasteful and expensive packaging measures, which is of course rubbish(pardon the pun). And I think this is where one of our fundamental problems lies. Making up our own rules and sticking by them is great if we want to supply to ourselves, but the moment we want to export our goods we simply have to bow to our customers’ demands. We do it to get FDA clearance or approval, so why not EU? Or are we going to have UK compliance, EU compliance AND UK compliance activities? Stopping this Little Englander behaviour seems to be a pre-requisite to starting a trading relationship with a post-Brexit Union of European States.
Awaiting official view
What then of the MHRA (Medicines and Healthcare Products Regulatory Agency) that is our de facto UK regulatory authority? The pre-referendum mood music was strongly in support of remaining, for a host of reasons, some of which I’ve gone into here. The agency’s warnings sounded rather like my words, with delays to market, difficulties and delays sharing clinical data about device-related problems to name a few. Read the Telegraph article here.
I picked up another piece, this time written post-referendum by Zachary Brennan of the Regulatory Affairs Professionals Society (RAPS), which you can find here. He’s suggesting that the MHRA is taking its time to “mull over” the implications of Brexit. And indeed why wouldn’t they because it’s a hugely serious business? Specifically referencing the medical device industry he echoes my view that sorting out the Notified Body confusion will be fundamental. Zachary quotes Sir Kent Woods, UK’s former chairman of the European Medicines Agency (EMA) board, and a prominent participant in those aforementioned medical device adverse event situations, who warned in May: “The UK on its own, representing 2.5% of the world pharmaceutical market, could not build an equivalent regulatory structure for an industry which is now truly global.” Pretty sure he’d include Medical Devices in that statement if asked.
So fingers crossed everybody. Everything will be fine, not least because the NHS is to be given £350 million a week to staff its hospitals and buy drugs and devices… isn’t it?
Written by: Nick Woods, editor of MedLatest and former medtech company director with over 30 years in the industry
published: June 28, 2016 in: medlatest Editorial, Regulatory