Medical Devices: the Big Regulatory Shake-Up - What Now?

    The significant step changes in medical device transparency & traceability requirements, under new European regulations, don’t just affect manufacturers. Notified bodies, competent authorities, importers and distributors will also have to prepare for continuous surveillance and improved rigor around product safety, says Ben Jacoby of Sensus Group.

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    While the new EU Regulations for medical devices (MDR), due to apply from mid-2020 (and, for in vitro diagnostic medical devices, IVDR due two years later), may feel fairly onerous to the medical device industry, few could object to the need for the sector to have greater safety surveillance.

    Although medical technology represents just 7 percent of healthcare spend in Europe, this includes some significant products which, if faulty or wrongly applied, could have catastrophic consequences for patients.

    So it makes sense that devices should be subject to more rigorous checks and controls which in some respects move closer to those that apply to medicinal products.

    Uncharted Territory

    The challenge for the medical device industry is that the sector is going to be forced through more stringent regulatory hoops which, until now, it has largely escaped; and some organizations are ill-prepared for compliance.

    At a manufacturer level, for instance, pre-market clinical investigations in the past have tended to be the exception rather than the rule, compared with the extensive clinical trials required of most human medicines. In earlier years some safety checks and after-market vigilance have tended to be finite events – risk management before delivery, then perhaps a one-off post-market surveillance exercise a few years down the line to ensure that all is as it should be. But now, as outgoing European directives give way to formal and significantly updated regulations, all sorts of formal checks and continuous monitoring will be needed across a medical device’s entire lifecycle.

    Those manufacturers and other parties across the supply chain and regulatory ecosystem without a history of these kinds of measures have a lot of catching up to do. As the typical medical device manufacturer in Europe tends to be fairly small in scale compared to the major pharma players, they may typically lack sufficient infrastructure, IT systems and human resources to conduct the increased monitoring and reporting that now needs to happen.

    Similarly, notified bodies, competent authorities, the European Commission itself, in addition to economic operators and especially importers and distributors of medical devices (who were not previously addressed specifically by medical device directives), must also get their own checks, controls and reporting facilities in order, so that everything joins up and patients are reliably protected.

    Public Confidence Counts on the Industry Getting This Right

    So there is a lot of work to do; and no time to lose if all of these industry stakeholders are to be ready to comply with the new regulations within the next few years--and, more importantly, maintain and raise public confidence.

    After all, the impact of all of this on patients, and those supplying or using higher risk devices (clinicians, hospital operating theaters, nurses and so on), will be that they are able to look up complete, standardized information on a specific device, in a central database (‘Eudamed’, in Europe), and trace that product right back to its source.

    By assigning greater accountability to all of the parties along the supply chain for performing due diligence/risk management checks, this is ultimately what will drive up patient safety – that and the ability to quickly trace and recall products in the event of a problem.

    In the US, which has taken a lead on medical device controls by specifying that high-risk devices carry standardized unique device identifiers, measures to formally improve industry traceability are advancing too. Meanwhile other regions around the world have already pledged to accept and uphold these international standards, even if they add their own nuances and proceed at a different pace toward these shared goals.

    So the pressures on getting this right are growing globally.

    Practical Pointers

    What next, then? With the clock ticking how should device manufacturers and organizations across the wider supply ecosystem proceed, to ensure they are compliant by the time they need to be?

    Although the Commission has yet to publish some of the required delegated and implementing acts, common specifications, and guidance, there is still plenty that the industry could—and should—be doing now.

    A good first step is to seek the right advice. And while a consultant would say that, this could just as well be by joining an appropriate trade association—a regional body like MedTech Europe, perhaps, or a national equivalent. Organizations also need to assess where they are now, and where the main gaps in visibility or capability are, so that they can formulate a plan of attack.

    Whichever path they take, industry stakeholders need to move quickly now because the requirements under MDR (and IVDR) are extensive, and complex. For example, even a small manufacturer could have anything from 10 to 50 distributors, whose contracts may now have to be reviewed­­—all of which will take considerable time.

    From a systems perspective, meanwhile, companies must ask themselves how they will meet criteria including “readily searchable” technical documentation. If such records do not yet exist in a standardized electronic form already, they will need to very soon. With all of the interdependencies between all of a company’s regulated information, it would certainly make sense to apply some kind of intelligence to its management, using appropriate software. (The regulations are very clear about the need for extensive reporting.)

    None of this is going to go away, so the sooner the medical device industry develops and takes action in line with the comprehensive plans it now needs to have in place, the stronger the chance organizations will have of being fully prepared once the deadlines hit. 

    Published on    Last updated on 03/07/2019

    #Globalization, #Life Sciences, #Linguistic Validation, #Clinical Trials, #Medical Devices

    About the author

    • Ben Jacoby Ph.D. is an experienced regulatory consultant at Sensus Group Ltd in the UK. He has worked with clients in the diagnostic, medical device and pharmaceutical industries to help them bring innovative products to market. He provides regulatory and strategic guidance on EU and US issues to clients, with recent regards to the new EU MDR & IVDR ‘gold standards’ and how best to support multi-national and SME companies throughout the transition. These were his reflections on his session at AMPLEXOR’s recent BE THE EXPERT industry forum in France.