We usually think of regulations in two ways: they’re either that boring, alien subject that you want nothing to do with, or a framework that puts your work into context, giving you some indication about the best path to take.
I prefer the roadmap approach, and even if the vagueness of the map and my own inability to read it sometimes takes me to an unknown place, it’s comforting to have a sense of direction.
Last week I gave you an overview of two EU regulations that impact the medical industry: GDPR and Medical Devices. This week I’ll take you through the ins and outs of some other regulations.
IN VITRO DIAGNOSTIC MEDICAL DEVICES
The in vitro diagnostic medical devices regulation (IVDR) is the second-born twin of the medical devices regulation (MDR). No one is talking about it that much because the first twin is getting all the attention, but that might change in the second half of this year.
Both regulations have two main concerns at their core: patient safety and transparency. These are addressed by several common aspects of the regulations:
– Increased expectations of clinical evidence
– Required performance evaluation and traceability
– Bigger scrutiny of manufacturers’ data
– Greater expectations of competent authorities and notified bodies
While the scope for IVDR is the same, with these regulations, the theme is “more”: more data, more safety, more documents.
There’s a problem about notified bodies: as their responsibilities increase, the number of existing notified bodies decrease, and there’s the concern that they won’t be able to keep up with the required amount of work. As I write this, there are three notified bodies for IVD, which seems hardly enough.
The new IVDR and MDR will be challenging because they require more technical documentation and an ongoing quality management system. Some people are afraid that this causes manufacturers to avoid the EU market thus restricting the availability of these products.
I can’t say what will happen, but I’m sure that having an agile system will at least minimise the impact of the EU regulations for manufacturers. The key aspects to achieve this are to have prepared professionals and enough notified bodies.
CLINICAL TRIALS
I studied the EU Clinical Trials regulation 536/2014 quite a lot in late 2015, while doing a clinical research associate course. Back then, the instructors introduced me to the Clinical Trials Information System (CTIS), a centralised database that should be up and running soon.
Unfortunately, “soon” has not yet arrived, and in the words of the European Commission: “Although the Regulation entered into force on 16 June 2014 the timing of its application depends on the development of a fully functional EU clinical trials portal and database, which will be confirmed by an independent audit.”
The latest update, given by the European Medicines Agency (EMA) in their official website is “In December 2019, EMA’s Management Board endorsed to commence the audit of the system in December 2020, following an audit readiness assessment carried out by the nominated product owners, EMA and the IT supplier.” We hope so.
But what changes with the new clinical trials regulation? And why is the Clinical Trials Information System so important?
According to EMA, the core values are the “highest standards of safety for participants and increased transparency of trial information.” We can definitely see a pattern in the EU regulations that are rolling out.
The CTIS will play a central role in reaching these goals, and in encouraging growth in the European clinical trials landscape. It will be the cybersafe beehive where regulators and trial sponsors can collaborate in the preparation and sharing of data and documents, while allowing the general public to access non-confidential information on clinical trials once the system is launched.
Having a centralised system for clinical trials submission streamlines the process and makes it faster, because now sponsors don’t have to submit the same trial to the national authorities of each country where it will take place. To further accelerate the submission process, the new regulation also reduces clinical trial authorisation from 60 to 45 days (for most cases).
So far, we have: more demanding requirements and less time to meet them. To cope, the medical industry professionals working in clinical trials must sharpen up their collaborative and project management skills.
The clinical trials regulation will be enforced six months after the CTIS is fully functional, and there will be a transition period of three years.
SUMMARY
The new regulations about medical and in vitro devices are upon us, and I feel there’s still some rough edges to smooth out with regulatory guidance.
The common thread that links these regulations is a move towards patient safety and transparency, which I believe are what should move our healthcare efforts.
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