This blog article was originally published as an expert article by MedTech Finland.
The European legislation on health tech is changing strongly.
New regulations for medical devices enforce and unify the practices that have been proven most efficient throughout the decades. The regulations also contain responsibilities for importers and distributors to ensure patient safety and the flow of information. From the perspective of the device user and the healthcare consumer, this direction seems right.
However, the EU Member State authorities, and groups responsible for crafting the important guidance documents, face an amount of work that is not particularly well matched with the available resources. Many guidance documents will be a long time in coming, even though the new Medical Device Regulation shall apply in its essential parts in two years, on 26 May 2020. The manufacturers are preparing for the change as we speak, but they are not certain of the ability of the European notified bodies to certify them during the transition time.
The In Vitro Diagnostic Medical Device Regulation shall apply two years later, from 26 May 2022, which appears to provide some realistic leeway.
Companies who are familiar with the current requirements, and have implemented their processes accordingly, have good or fair chances to survive the transition. New companies, especially startups, have a lot to investigate both from current and new legislation. In September 2017, I wrote in MedTech Views on the legislative challenges of health tech startups. Since then, I have gotten to know a much wider spectrum of companies, to whom the medical device legislation is new. Among them there are pharmaceutical manufacturers and software houses that already work according to high quality standards, so they are not quite startups; but the device legislation requires a moderate investment from them all the same.
It is essential for every operator in the supply chain to avoid functional and business-related risks by examining the requirements on, for example, the quality system, the technical file of a device, vendorships and distribution. I am delighted to notice that a startup which has been around for a while can be more open to the requirements and have used more agile means to implement them than the larger newcomer. But I still think the pressure created by the new regulations will slow innovation, and will need new solutions on the EU and national level.
The new regulations contain a lot of challenges, and technology evolves at a pace that guarantees the legislation and its supervision must keep up and must become more interactive. Meanwhile, the manufacturers shall invest in clinical evaluation and risk management practices, which are underlined by the regulations. This is to create justified positions to challenge the authorities and other stakeholders into an intelligent debate instead of getting stuck with legislative meanderings. This will give the technology its shot to end up in the hands of healthcare professionals and consumers as safe and efficient devices.
Today, the line between pharma and health tech gets thinner and thinner. Many manufacturers of pharmaceuticals work on software and equipment intended to enhance the benefits of the medicine or to make the patient’s life with the medicine easier. Some health tech manufacturers advance toward biology, working in the borderline of devices, medicine and tissue engineering, not to forget companies developing artificial intelligence, which is a substantially growing part of health tech.
Health is one of the basic needs of humanity. This guarantees that, despite the challenges, medicine will evolve and the related industry will keep on growing. This industry requires patience from scientists, product developers, investors and decision makers. It is for the benefit of each EU Member State if the local authority holds sufficient networks, resources and knowledge to work proactively with the exporting industry and other stakeholders.
The most significant changes brought by the new regulations:
- Reclassification of some devices into a higher class, resulting in an increase in requirements and oversight: especially software as a medical device and devices containing software, as well as in vitrodiagnostic devices.
- Emphasis on clinical evaluation, risk management and benefit-risk analysis throughout the product life cycle.
- Stricter control of the entire supply chain, starting from vendors and ending at increased requirements for importers and distributors all the way to post market activities.
- More stringent requirements on clinical evaluation and oversight for the highest device class.
- More stringent quality system requirements for the lowest risk class devices.
- Bringing specific products, that do not have a medical purpose but which are similar to medical devices, under medical device regulations.
- Establishing the European database on medical devices (Eudamed) and defining responsibilities related to the database for the economic operators in the supply chain.
- Deployment of the Unique Device Identifier (UDI) for medical devices and connecting the identifiers with the Eudamed to enhance the follow-up on vigilance activities.
- More stringent requirements on the notified bodies (e.g. regarding their clinical know-how).
- More defined and increased responsibilities of European authorities across the board.
- Substantially more requirements and contents to become familiar with.
The political pressures and Brexit bring uncertainty to the transition. The British have a substantial role in the European health tech industry and in related law enforcement and certification work. If the British notified bodies cannot renew their mandate, the bottleneck that is already experienced in certification will get worse. Especially the manufacturers that are entering the market for the first time, and the products that are the most innovative, will more likely end up in the back of the line.