New regulations for medical devices, in vitro diagnostics approved

April 6, 2017
The new Regulations on medical and in-vitro diagnostic medical devices proposed by the Commission in 2012 will help to ensure that all medical devices - from heart valves to sticking plasters to artificial hips – are safe and perform well.  The Medical Device Regulation (MDR) and the In-vitro Diagnostic Regulation (IVDR) replace three directives dating from the 1990’s.
To address the many technological and other developments since then, the new rules will improve market surveillance and traceability (through a UDI-system like the one already in place in the US),  as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.

El?bieta Bie?kowska, Commissioner for Internal Market, Industry, Entrepreneurship and SMEs, said: "I'm extremely happy that our push for stricter controls of medical devices on the EU market will now become a reality. Whether for medical devices, cars or other products, we must ensure stronger supervision in the interest of our citizens. We should not wait for another scandal instead we should start a discussion how to strengthen European oversight over Member States' market surveillance activities."

Number of improvements

The two new Regulations bring a number of improvements for medical and in-vitro devices:

  • Improve the quality, safety and reliability of medical devices: The new rules will impose tighter controls on high-risk devices such as implants, requiring a pool of experts at the EU level to be consulted before placing the device on the market. Controls will also be tightened on clinical trials as well as on the bodies that can approve the marketing of medical devices. The new rules will also cover certain, previously unregulated aesthetic products (e.g. coloured contact lenses that do not correct vision). In addition, a new system for risk classification in line with international guidelines will apply to in vitro diagnostic medical devices.

  • Strengthen transparency of information for consumers: The new regulations will make sure that vital information is easy to find. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product so that it can be found in the new European database of medical devices (EUDAMED).

  • Enhance vigilance and market surveillance: Once devices are available for use on the market, manufacturers will be obliged to collect data about their performance and EU countries will coordinate more closely in the field of market surveillance.  

Half a million medical devices in EU

There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Examples of medical devices are contact lenses, x-ray machines, pacemakers, breast implants and hip replacements and sticking plasters. In vitro diagnostic medical devices, which are used to perform tests on samples, include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.

The existing regulatory framework dates back to the 1990s and consists of three Directives. However, problems with divergences in the interpretation and application of the rules, technological progress as well as incidents involving malfunctions of medical devices–i.e. the PIP breast implant scandal- highlighted the need for revision of current legislation. The Commission is also currently working on more structural and horizontal solutions for better market surveillance within the broader frame of a goods package reform.

To address this, the European Commission presented two legislative proposals on medical and in-vitro diagnostic on 26 September 2012. This was followed by extensive expert consultations that resulted in an agreement on the general approach to the medical devices package among Member States' health ministers on 5 October 2015. The adoption of the package by Parliament, following today's vote in plenary, fully reflects the position of the Council reached in its first reading and in turn the agreement of the co-legislators from June 2016, therefore allowing to conclude the legislative process.

To allow manufacturers and authorities to adapt, the new rules will only apply after a transitional period, namely 3 years after publication for the Regulation on medical devices and 5 years after publication for in the Regulation on vitro diagnostic medical devices.

Safer, more innovative devices

The final Regulations contain very important changes to the current system to enable the sector to produce safer and more innovative devices and help address future challenges. The new Regulations contain many provisions to increase security and regulatory certainty (harmonised rules on drug-device combination products, tissue engineering, nanoscience, personalised medicine, substance based devices and genetic tests) and take into account the latest developments in the sector (medical software, apps, cybersecurity).

To help boost innovation in the sector, the EU-wide database on medical devices (EUDAMED), supported by a new device identification system based on a unique device identifier (UDI), will make big sets of data in the field of medical devices available within the EU. By producing more innovative devices, medical device manufacturers will also be able to offer solutions for disease prevention or early diagnosis that will in turn make the healthcare sector more affordable, by for example helping to prevent or reduce hospitalisation.

Specific rules for nanomaterials

The new Regulation on medical devices lays down a dedicated classification rule for devices incorporating or consisting of nanomaterials. The critical factor is the potential for nanomaterials to be in contact with membranes inside the body. Those devices presenting a high or medium potential for such contact will fall under the highest risk class and thus be subject to the most stringent conformity assessment procedures.

The medical devices sector is a global leader and a major employer in Europe: it employs more than 500,000 people in over 25,000companies. The sector is driven by small and medium-sized companies (SMEs) and the new Regulations will help the EU industry to maintain and further expand its leadership role on the global scale, by making it more competitive and more solid in a complex global environment.