June 2016 has seen the publication of a new raft of amendments to the 2015 output, all of which form a proposed new European Medical Device regulations. This may feel like old news, given the fact that changes were first outlined almost four years ago. And it’s still at least three years until the new rules get implemented, giving industry plenty of time to adapt to the changes. At first reading, there are no fundamental surprises, especially given the fact that we were all prepared for a significant toughening up in the aftermath of a number of painful experiences for industry and regulator alike.
We wrote tens of thousands of words on the subject of regulatory changes a few years back, urging lawmakers not to throw out the baby with the bathwater in a knee-jerk post-PIP, post all metal hip, post ICD lead toughening up. And while these things seem to drag on for longer than one would imagine necessary, the new proposal with its raft of language changes, looks like a collection of sensible, unsurprising and workable measures to ensure we as a collective, do things better in the future.
Summarising the 224 pages is rather pointless, but for busy people, let’s try, bearing in mind that some of this has already been in the public domain for a while:
Firstly, the rules stated aim is to link the twin demands of providing a high level of protection of health, while ensuring the continuing functioning of the market (this now extends to the “smooth” functioning, thereby softening a bit compared with the pervious version. This point also drives home the established message that clinical data used in pursuing regulatory approval is “reliable and robust” while protecting the study subjects. Key elements of the pre-existing proposals remain, including the “supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding devices should be introduced, to improve health and safety.”
This means many things, one of which is that the functional relationship between Notified Body and company will change from the slightly too friendly consultant-type relationship, to policeman. Monitoring of Notified Bodies by their respective member State will be beefed up, and they will be given the authority to make unannounced “on-site audits.” All of this will be made more transparent with the introduction of the need for national authorities to publish the results of their assessment, designation and monitoring of Notified Bodies. One interesting addendum is that Member States will be able to make additional demands of their Notified Bodies beyond the requirement of the EU legislation, which one imagines might see countries vying for top spot in the “look how tough we are” stakes.
One thing we’d expressed a hope for early on was that the pragmatic solution to the conflict between the benefit of getting new deices to market quickly, while also ensuring their safety, lay in improving the use of post-marketing surveillance. Reassuringly, this is a key point in the new regulations, which state that “It should be ensured that supervision and control of the manufacture of and the post-market surveillance and vigilance activities of medical devices is are carried out within the manufacturer’s organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.
One interesting new rule relates to software, which now states that when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, then it’s a medical device. Helpfully, software for general purposes, even when used in a healthcare setting, or software intended for well-being application is not a medical device. The qualification of software, either as device or accessory, is independent of its location or type of interconnection between the software and a device. Useful, and indeed essential clarification.
There’s also significant treatment of the need for so-called Unique Device Identification (UDI) labelling in order to ensure traceability in the event of malfunction or recall, all done on a central database.
For those devices classified as higher risk (Class III implantables), conformity assessment will now require clinical expert panel scrutiny of Notified Body assessment. New to the draft is the introduction of the ability for the manufacturer to itself consult the clinical panel prior to undertaking its clinical study, which seems like a wholly acceptable way for companies to ensure they’re barking up the right tree.
And on so-called invasive products, the definition of invasiveness will be clarified by the introduction of more specific classification to include such factors as “the place where the device performs its action in or on the human body or is introduced or applied and cases where a systemic absorption of the substance, or the product(s) of its metabolism, is present.”
So there you have it, at least as far as the headline grabbers go. We’ll do a little more unpicking, but at first read this looks like tweaks to a set of regulations that are highly likely to fulfil the stated aim of heightening public protection against bad device-related clinical consequences, while not stifling the introduction of innovative solutions.
The devil, of course, is in the detail and in the implementation of all of this.
Source: Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009