Read this month’s EU Affairs update on the EU’s new regulation on medical devices and the ESR’s paper on the General Data Protection Regulation.
Medical Devices Regulation
The April 5 plenary vote in the European Parliament on the regulations for medical devices and in-vitro medical devices was the final step in a major overhaul of the regulatory environment for medical devices in Europe. Replacing the 1990 directive on active implantable medical devices and the 1993 directive on medical devices, the medical devices regulation (MDR) is intended to enhance the safety of medical devices for patients in Europe while retaining the competitiveness of the European medical device market. The revisions affect all types of devices, from home-use items like sticking plasters or pregnancy tests to diagnostic imaging equipment or pacemakers.
The legislative process started with a public consultation in 2008, followed by the publication of the European Commission’s legislative proposals in 2012. During protracted negotiations within and between the EU institutions, the final consensus eventually emerged: retaining the decentralised character market authorisation while enhancing patient safety by strengthening oversight of notified bodies, stricter requirements especially for high-risk devices, or new rules for traceability of devices and incident reporting.
The technical documentation required for market authorisation is more detailed in the new MDR, and it includes a new requirement of periodic updates that must take post-market surveillance data into account. Each device must have a unique device identification number for traceability, new classification rules are introduced, and the requirements for re-using single use devices were strengthened. The new regulation also includes specific rules for software as a medical device, accounting for the significant developments in this area in the past 20 years. Notified bodies were empowered to conduct unannounced factory inspections, and for high risk devices notified bodies are to seek advice from an expert panel designated by the European Commission. In addition, a pre-market scrutiny procedure is introduced for certain types of high-risk devices through which national competent authorities can review checks carried out by notified bodies and verify technical documentation. This move was criticised by some industry groups for the potential duplication of work for manufacturers.
Throughout the legislative process, the ESR advocated for a balanced approach centred on patient safety, while safeguarding an efficient regulatory system that ensures timely access to new and innovative technologies.
The MDR will apply after a transition period of three years, while new rules for in-vitro medical devices apply five years after publication in the Official Journal of the European Union. Both regulations were published in May 2017.
ESR GDPR paper
The new EU General Data Protection Regulation (GDPR) applies from May 2018 and represents a significant overhaul of European data protection legislation. The GDPR considerably expands the scope of EU privacy legislation and introduces new rules for consent requirements to collect and process data, rights to erasure, data portability, and the use of health and research data. The GDPR is also a central part of the European Commission’s digital single market strategy, designed to boost digital innovation.
The regulation affects the area of healthcare and radiology in many ways and includes specific rules and exemptions for medical professionals and researchers.
The ESR paper The EU General Data Protection Regulation: what the radiologist should know includes an overview of the parts of the legislation most relevant to radiologists, clarifies key rules and terms, and provides insights into what impact the GDPR will have on clinical practice.
The paper, published in Insights into Imaging in April 2017, is available here: