Measured implementation in the interest of patient safety.

RB – 10/2019

Following long and intense political debate, the European Medical Device Regulation came into force at the end of May 2017. The core aim of this Regulation is to make the placing on the market of medical devices safer, to increase the requirements for the clinical assessment of high-risk products, to create transparency through a central database and to harmonise the quality of Notified Bodies throughout Europe.

In addition, the new Regulation now assigns certain medical devices to a higher risk class. This revision was necessary because the classification rules of the previous directives dating from the beginning of the 1990s had to be updated to the current state of the art of medical devices. This especially applies to software, for example certain apps, which can have a significant influence on therapeutic decisions in the event of heart failure or depression. Wrong decisions can lead to the death of those patients affected. According to the rules of the new Regulation, this type of software is now placed in Class IIb, whereas previously it was in Class I.

An important and long-overdue step towards improving patient safety and quality of healthcare

The German National Association of Statutory Health Insurance Funds (GKV Spitzenverband) views the new Regulation as an important and long-overdue step towards improving patient safety and the quality of healthcare using medical devices.

In order to ensure a smooth transition from the current EU legislation on medical devices to the new EU Regulation, the rules for active implantable medical devices and in vitro diagnostics will be phased in from a later date. The Regulation has several deadlines. One deadline stipulates that medical devices must be placed on the market in accordance with the new Regulation from 26 May 2020. Notified bodies must be designated by the Member States in a timely manner in accordance with the new EU Regulation in order to enable them to issue new certificates for placing medical devices on the market.

However, there is a transitional period for certificates issued under the old EU legislation, the validity of which extends beyond 26 May 2020. Medical devices with certificates issued under the old legislation may remain on the market until this certificate expires or until May 2025, whichever comes first.

Manufacturers of Class I medical devices, whose products are now classified in a higher risk class by the new classification rules, must place these on the market according to the provisions of the new EU Regulation as of 26 May 2020.

Criticism from industry and politics

Representatives of industry and government have criticised the Regulation for several months, claiming that the demands placed on medium-sized companies are too high and jeopardise the supply of medical products. They have highlighted problems with the implementation of the Medical Devices Regulation in terms of timing and content.

Position of the GKV Spitzenverband

The main aims of the new Medical Devices Regulation are to improve the safety of medical devices, to ensure uniform quality of notified bodies throughout Europe and to improve transparency. Since the Regulation came into force, both the Member States and the EU Commission have been working on its implementation and are currently creating the necessary structural framework conditions.

Harmonising and improving the standard of quality of notified bodies also means that certain notified bodies, which do not meet the new quality standards, will no longer be able to continue operating as they currently do. It has therefore always been assumed that fulfilling the new quality standards will require a lot of effort on the part of many notified bodies in terms of infrastructure and personnel, and that there will probably be fewer notified bodies in the foreseeable future than under the old medical devices directives.

Of the 59 current notified bodies, 47 had applied for new designation by the end of May 2019. 26 have already been through a joint assessment, and seven further assessments were agreed at the end of May[1]. The EU Commission has stated several times that it expects that by the end of the year around 20 notified bodies will have been approved and be able to commence operations.

Persons with statutory health insurance in Germany are entitled to a supply of marketable medical devices which meet quality and efficiency requirements. The secure supply of medical devices to persons with statutory health insurance must not be jeopardised at any time.

In the event that reliable figures on directly affected manufacturers and products indicate that a specific problem exists with regard to the transitional periods, targeted measures must be put in place to solve the problem identified.

In a ministerial letter to the EU Commission dated July 2019, German Federal Health Minister Jens Spahn referred to a survey of Member State authorities which indicated that about 150,000 products from 4,000 manufacturers require certification by a notified body for the first time due to new classification rules. The GKV Spitzenverband is not aware of any specific details about the products affected. Nevertheless, given the pure size of this estimate, it seems appropriate to create an exception which would allow these products to remain temporarily marketable according to the old EU directives. This period should enable manufacturers and notified bodies to implement the quality standards required by the new legislation and avoid possible supply shortages.

However, the GKV Spitzenverband strongly warns against calling into question or postponing the Regulation’s date of application in its entirety. Manufacturers, authorities and notified bodies have had enough time to prepare for the Regulation’s date of application, which has been known for years.

[1] Dr Martin Renhardt, Austrian Federal Ministry for Labour and Social Affairs; EUNetHTA Workshop, Vienna, 28 May 2019., Page 14. Accessed on 08 Aug 2019.