EU Medical Device Regulation: What’s the impact? EU Medical Device Regulation: What’s the impact?

Following various incidents in recent years, the control mechanisms for medical devices are being tightened throughout Europe with the new EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). What is the impact of these EU regulations for Switzerland and how do you ensure compliance on your end by the time the transition period ends?

The new regulations came into effect on 5 May 2017. They are replacing the EU’s Medical Device Directive (93/42/EEC), Active Implantable Medical Devices Directive (90/385/EEC) and In Vitro Diagnostic Device Directive (98/79/EC), and have a transitional period of 3 years for MDR and 5 years for IVDR. Switzerland plans to adopt these changes as well to make sure that Swiss companies remain competitive in the European market and elsewhere.

One of the key goals of the initiative is to increase patient safety by improving the quality and safety of the medical devices and harmonizing the legislation within the EU. Overall, the requirements to get a medical device approved will be tightened and the process will become more standardized. This affects clinical trials, performance tests but even such basic aspects as the identification and traceability of products.

Today, the medtech industry and regulators are facing significant challenges. Companies are busy changing their processes in order to comply with the new regulations. In the meantime, the EU is struggling to get a pan-European registration platform ready and to staff its departments adequately so they can respond to the myriad of expected filings.

In a worst case scenario, some crucial products could be taken off the market because they were not registered or approved in time. Other products might disappear due to a consolidation of market players and/or portfolios.

The pharma industry has been operating in such a rigid regulatory environment for years and is used to the pressure. Traceability, standardized registration and approval processes fosters high quality. In the long run this is to the benefit of the patient’s security but it also reinforces the reputation of the product.

The changes are significant for companies dealing with products subject to the EU-MDR. Although the two new regulations are driven by the EU and apply to EU parties, their scope extends far beyond European territory. Any medical devices manufacturer based outside the EU exporting to EU member-states is subject to the legislation in the sense that its importer and distributor is liable for their compliance.

Right now, Switzerland covers these aspects with the help of the following:

• The Swiss Agency for Therapeutic Products (the Institute), based in Bern issues the technical standards and the common technical specifications that medical devices have to meet. A European Commission representative may participate in the evaluation of the conformity assessments carried out by the Institute. This interaction with the EU includes on-site assessments.
• Market surveillance (post-control) checks ensure that medical devices entering the market, their distribution, product monitoring and handling of medical devices comply with regulatory requirements.
• During the specified period of product usage, Switzerland must be in position to recognize the dangers that a product may present, prevent possible endangerments and make products traceable. For this purpose, the company placing the product on the European market is asked to implement a product monitoring system that records product-specific complaints, relevant experience of application, reports of the trade press and own examination results. Also, corrective actions need to be taken as soon as a complaint is lodged against a product.

Compliance with the new MDR/IVDR regulation might cause affected companies additional work. It is crucial to evaluate your product portfolio based on the new regulations and conduct a risk and priority assessment. You will also need to look into the process for device registration and approval, the coordination and communication with the regulatory bodies.

Given the three and five-year transitional periods and the technical as well as organizational efforts, it is crucial to start this journey to compliance as early as possible. It is best to start the process with a sparring partner that is knowledgeable and who has already registered products with various authorities in order not to leave out any important detail.

Regulatory improvements always come with a price tag. In the case of the new MDR/IVDR regulations it is quite hefty as it brings fundamental changes. It will most certainly also increase the already high healthcare costs. It is difficult to predict how this will affect Switzerland’s medtech industry. What is quite sure already now is that it will inflict additional pressure on budgets, margins and the entire business planning in life sciences.

Factsheet: Are you ready for EU MDR? (PDF)