Medtech regulatory service providers cannot afford to "wait and see" on the final outcome of Brexit. Questions such as the appropriate base of operations to serve device companies looking to sell into the UK and the EU are swirling. So how should the sector be covering its back? Medtech Insight spoke to John Adcock of Advena, a consultancy that serves as an authorized representative, to find out his views.
What regulations will medical device businesses have to follow after the UK exits the EU – the existing EU Medical Device Directives, next year’s new EU Medical Device Regulation and the MEDDEV associated guidance, or something new? And what avenues will there be to trade with the EU, and for the EU to trade with the UK? These are among the questions that are facing all device manufacturers and distributors that are either based in the UK, or are selling into the UK and EU.
John Adcock is managing director at Advena, a UK-based consultancy specializing in authorized representative services. Firms like his need to support not only UK-based industries as a result of Brexit, but they also must consider the future situation for firms exporting into the UK and the EU.
Provided that effective government pressure can be applied to assure some form of reciprocal medical device trade with EU countries, it could work out satisfactorily, Adcock said. But that does not lessen the current uncertainty surrounding the role and status of some of the key economic operators with whom manufacturers must interact, such as notified bodies, authorized representatives, and even their EU importers and distributors, he noted.
Medtech Insight invited Adcock to explain his views and why his UK-based consultancy has recently set up an office in Malta – a critical choice in the light of the pending Brexit.
Q: Medtech Insight: What will the UK’s role be in shaping device regulation in the post-Brexit future?
A: John Adcock: If we leave the EU, the good news is that it may be possible for the UK’s Medicines and Healthcare products Regulatory Agency to still have some global influence to support device regulation internationally. But there is concern about how the UK could assure that its own medical device industry is able to compete in the EU if they have no say-so on inherited EU regulation. The MHRA is certainly making the point that it is a key EU medical device player with respect of the up-and-coming regulatory changes, but the political climate in the EU could still push them to one side. There may be no appetite in Brussels to have the UK try to tweak regulations to suit themselves if they are not members of the “club.”
Q: What will happen to notified bodies in the future, in your view?
A: Adcock: That is a good question. We don’t know at this point because it depends on the agreement that the UK reaches with the EU. But if there is no straightforward recognition in the EU of UK notified bodies, issues that will arise will include whether the notified bodies will all need dual – or alternative – EU addresses, and need to be accredited from new EU addresses. Otherwise, it seems likely that companies will have to change notified bodies. We know that BSI and other major UK notified bodies, are not, apparently, concerned as they have bases in other EU counties and could operate their certification business from these alternative sites, but how much influence they will have in standards-making for any new state-of-the art medical devices is a big unknown. Indeed, when it comes to standards, there is a question over what standards the UK insist on for products to be sold in the UK? And will European standards still be used even though BSI may have no further influence on amendments?
Q: What about the future for authorized representatives?
A: Adcock: Authorized representatives, and indeed all consultants, must be ready to lead and work with both the national and international medical device industry now to assure they support their clients, whatever the UK and EU politicians throw at them. Certainly we have found that the Brexit news is now out internationally and many new clients are showing concern about locking into using authorized representatives who have their “registered place of business” in the UK and depend on UK MHRA registration processes. Other questions include whether medical device manufacturers from the UK will need authorized representatives to sell in the remaining EU countries. Also, whether the UK will set up its own requirements for authorized representatives so manufacturers from outside the EU may need two authorized representative names and addresses, one for the UK and the other for the EU. Whatever happens, the UK-located consultants will have to compete with the major EU consultants who offer EU-based authorised representative services and EU local registrations.
Q: What about the need to have a base in an English-speaking country for North American clients, for example?
A: Adcock: Authorized representatives, and other consultants, particularly those working with North American manufacturers and in other major English-speaking international locations, may need to still be based in prominently English-speaking countries so as to offer an assured service. Non-EU manufacturers will certainly feel more comfortable with that scenario, especially if they have been working with UK consultants for many years. This is another reason why they may need to offer authorized representative services from two locations, the UK and the EU if they are to ensure continuity of service. All these factors could lead to there being more consultancy companies with two or more registered places of business.
Q: What has the response been at your company in terms of its role as an authorized representative, and would you recommend this to other authorized representatives?
A: Adcock: After extensive research, Advena has set up a subsidiary office in Malta for EU registrations. In Malta the company is still “Advena Ltd.,” and only the address is different. This could be particularly comforting for clients who may need to change their labeling in the future. Others may follow, but there are not too many English-speaking EU countries like Malta with cost-effective registration systems [and] few bureaucratic hurdles.
Q: So, in light of these uncertainties, what would you advice industry to do?
A: Adcock: Medical device manufacturers and their contracted authorized representatives must practically and efficiently work through any political eventuality that Brexit is throwing at them. It is no good despairing – although very tempting for some – but there are opportunities that could start to be worked on now that we have some form of timetable. Of course, we still don’t know how the regulations will pan out and what regulations the UK will adopt, so the unknown will be there for some time – it may take months or even years to get the full facts. However, the option to do nothing, and not to plan ahead for all eventualities, would not be a wise business decision.
From the editors of Clinica