Regulation on medical devices in spotlight again

The countdown has begun

Starting on 26 May 2020, medical devices must be placed on the market in accordance with the new EU legislation. According to the new Regulation, new medical devices may only be approved by notified bodies that are accredited according to the new requirements of the Medical Devices Regulation. A single conformity assessment procedure will thus be implemented throughout Europe, which, in contrast to the previous procedure, tests new products more rigorously and also monitors manufacturers more closely. During the legislative process, the German statutory health insurance funds welcomed these changes made in the interest of patient safety.

German-Irish initiative to extend implementation deadline

The Health Ministers of Germany and Ireland jointly addressed the Commission at the Health Council meeting on 14 June 2019 in order to obtain an extension of the deadline for implementing the new Regulation. Hungary and Bulgaria were in favour of this extension, whereas France considered an extension of the deadline to be a last resort. Many other Member States, such as Belgium, Cyprus and Lithuania, opposed it. However, the Member States agreed that the implementation of the new requirements has been unsatisfactory so far.

 

The Commissioner for Health, Vytenis Andriukaitis, did not support the German-Irish initiative. An extension of the deadline would disadvantage market participants who have made extra effort in recent months to be prepared in time. He also referred to patient safety, which will be improved by the new rules.

Statutory health insurance against longer transition period

The German statutory health insurance is against a longer transition period before the rules of the new Medical Devices Regulation become applicable. The vast majority of notified bodies, whose task it is to assess the processes of placing medical devices on the market, have already applied for designation under the new legislation. The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) is of the opinion that the transition period should now be used by all parties to ensure a smooth transition from the old legislation to the new Medical Devices Regulation. Industry associations in particular are called upon to support this process by providing information to their members. This is in the interest of patient protection and would strengthen Germany’s position as a location for innovation.

  

The latest publications of the ‘Implant Files’ should be incentive enough to quickly implement the new Medical Devices Regulation and adhere to the timeframe. In addition to the German statutory health insurance, the European Social Insurance Platform (ESIP), the association of social insurance institutions in Europe, has also called for the timely implementation of the new rules in a joint statement.

What happens next?

At the moment, it can be safely assumed that there will not be a sufficient number of Notified Bodies to meet the new requirements by 26 May 2020. There are currently two institutions in the EU which are certified according to the new criteria of the Medical Devices Regulation and may therefore approve medical devices according to the new quality criteria. One of these is TÜV SÜD in Munich and the other is BSI in the UK. It is estimated that by the end of the year a total of 20 notified bodies will be ready to operate under the new rules. However, this is also seen more as an optimistic assessment.

 

Certificates issued before 25 May 2020 will remain valid until the date stated in the certificate, albeit no later than May 2024.

 

Information from the European Commission on the status of outstanding and ongoing accreditations would also contribute to a more objective discussion. The website currently only lists the above-mentioned accredited bodies (as of 18 July 2019).

 

Furthermore, it is currently impossible to obtain an overview of all medical devices available on the European market. There is also currently no possibility to view data on the safety and efficacy of individual medical devices at a central location. Under the new Medical Devices Regulation, EUDAMED is to be introduced as a central database for medical devices. It will start operations in March 2020 and part of its content will be publicly accessible.

Brexit

In the event of a hard Brexit, the situation will have to be assessed separately. The notified body (BSI) based in the UK has already put in place a contingency plan for Brexit. The company has informed manufacturers that it will assist them with migrating their certificates to their notified body in the Netherlands.

 

Thus, Brexit per se must not be an argument to soften the deadlines for compliance with the Medical Devices Regulation. Based on an analysis of which product groups are affected by Brexit, pragmatic solutions could be found which take into account the necessary level of safety.

Background

On 25 May 2017, the Regulation on medical devices (2017/745) came into force. The need to revise the medical devices Directives from the 1990s resulted from scandals involving the use of defective medical devices. The articles published on the Implant Files website have again confirmed the shortcomings in the market for medical devices (See our article from January 2019).

 

The new medical devices Regulation addresses the need for action and creates a regulatory framework to improve patient safety, improve the quality of healthcare and coordinate market access for innovative medical devices in the EU. The aim is to ensure high-quality, safe and transparent access to medical devices for patients and service providers in the EU.