In September 2019, KPMG issued a report exploring the race to EU MDR compliance amongst medical device manufacturers. Elizma Parry, Director, Global Clinical Practice at Maetrics takes a closer look
One of the findings was that only 27% of companies said they would be fully compliant with the new regulations set to go into effect, whereas almost half of the respondents said they would likely withdraw medical devices from the market owing to the new regulations.1
If medical device manufacturers are struggling to get their ducks in a row, pharmaceutical manufacturers will most likely have an even harder time preparing for the imminent deadline. This is a wake-up call for those companies that manufacture combination products and/or companion diagnostic devices.
Although their involvement may be less obvious, they will in fact be equally impacted by the EU Medical Device Regulation (MDR) and EU In Vitro Device Regulation (IVDR). The transition period ends on 26 May 2020 (May 2024 for those already CE marked under MDD93/42/EEC) and May 2022, respectively.
Non-compliance may result in restricted market access and product withdrawal, so it’s fundamental that these businesses act now to avoid such unwanted outcomes.
Combination products are made up of at least one-part medical device and one-part medicinal substance, with one playing a central role and the other a more ancillary one. A few examples of combination products with ancillary device components are insulin injector pens and metered-dose inhalers, in which the device serves as the delivery system of the integral drug component.
Under current regulation, such combination products in which the medical device has an ancillary function are regulated as medicinal products. Come May 2020, however, they will be regulated with the same scrutiny as standalone medical devices under Article 117 of the EU MDR. This move stems from the increasing complexity of combination products and the subsequent need to regulate ancillary device components with greater intensity.
By contrast, companion diagnostic devices help to strengthen the safety and efficacy of a medicinal product by assessing which patients would most benefit from treatment ... and which may experience adverse effects from it.
Companion diagnostics, in turn, will now fall under the remit of the EU IVDR. Under the IVDR, companion diagnostics fall under a medium-high-risk category (Class C, with D being the highest risk class) and will, accordingly, be subject to a high level of clinical scrutiny.
Clinical data collection is a key part of achieving EU MDR compliance. Given their unfamiliarity with this process, it is crucial that pharmaceutical manufacturers begin to assess which data they are missing early on. Once these initial assessments are complete, manufacturers can begin gathering additional clinical data to submit their clinical evaluation reports.
Doing new studies will be time-consuming and costly … but investing resources at this stage of the process will help to guarantee a smooth transition and make maintaining up-to-date data much easier in the future.
Following this same rationale, pharmaceutical manufacturers may be reaching out to a notified body for the first time. In this case, they should be made aware of the current shortage of designated organisations in Europe. Today, there are only six notified bodies available to review technical documentation under the EU MDR.
The IVDR sphere is worst affected by the notified body shortage, as there are currently only two (BSI Group and DEKRA) designated notified bodies to review documentation.
With so few organisations at the disposal of manufacturers, it is estimated that designated notified bodies will find themselves beyond capacity and delays will most likely ensue. Manufacturers are therefore encouraged to begin investigating and approach notified bodies while awaiting designation from their national competent authority for their specific product area to get a good spot in line.
Dealing with this regulatory minefield is an important task on its own, but this is exacerbated by the limited availability of notified bodies on which pharmaceutical manufacturers depend to achieve compliance. Such circumstances should further prompt manufacturers to submit their documentation as early as possible to make sure they receive their approval under the EU MDR and EU IVDR before the applicable cut-off dates.
A good start is for manufacturers to gain full awareness of how these new regulations will affect their product range and then evaluate whether they have in-house competence and resources at hand to work effectively through the compliance process or whether they need to reach out to third-party qualified expert professionals.