GKV-Spitzenverband puts forward recommendations for Regulation.

RB – 03/2020

In recent weeks and months there have been many proposals to temporarily repeal the EU Medical Devices Directive (MDR) or to put a moratorium in place. The reason behind many of these initiatives is the fear that due to real or alleged difficulties transitioning from the old EU legislation to the new one, a large number of medical devices could suddenly be no longer available because they will lose their market authorisation. Representatives from the medical technology industry are again using the current supply shortages as an opportunity to pressure the EU Commission to delay the MDR entering into force, seemingly with success.

EU Commission wants to postpone MDR date of application for one year

As the corona virus began to spread, the European Commission took measures to provide targeted support for the growing need for medical devices in medical care. In addition to establishing the ‘rescEU stockpile’ for selected products and a joint procurement system, the European Commission has also taken targeted steps to ensure adequate supply of medical devices during the corona crisis.

Despite these various measures to improve supply, the EU Commission announced on 25 May 2020 that it is working on a proposal to postpone the date of application for the MDR by one year. The aim is to give manufacturers the freedom they currently need to produce enough equipment to meet demand in the current corona crisis.

Ensuring supply of medical devices without postponing MDR

Dealing with the current corona crisis must take priority at EU level. However, at the same time, the safe supply of high quality medical devices in Europe must be guaranteed even during the COVID-19 pandemic. Against this background, Germany’s statutory health and long-term care insurance funds are concerned about the Commission’s intention to postpone the date of application for the EU Medical Device Regulation (MDR). In their statement, they point out that the widespread problems with procuring and distributing equipment such as respiratory masks, protective clothing, disinfectants or ventilators are due to sudden and exceptionally high demand. However, this is not related to the implementation of the Medical Device Regulation.

The citizens of every European Member State have a right to high-quality healthcare with safe medical devices – even during the corona crisis. National solutions are just as ineffective as a sudden suspension of the new EU regulation. Postponing the new regulation would exacerbate existing planning concerns among companies, notified bodies and authorities, because the transition process from the old to the new legislation is in full swing. Many manufacturers have been preparing for the new requirements for years. The same applies to the notified bodies. All major notified bodies have already successfully received their new designation or are in the middle of the designation process. National legislative processes are also already in advanced stages and will have to be withdrawn, while the authorities are preparing themselves for new tasks in terms of staffing and structures.

Any short-term, exceptionally high demand for medical devices due to COVID-19 should be looked at separately from the planned implementation period of the Medical Device Regulation. The statutory health and long-term care insurance funds have proposed a solution that will further ease supply shortages, but at the same time will not jeopardise the Medical Device Regulation’s date of application on 26 May 2020.

The statement and its proposal can be read here (German only).

What happens now?

The European Commission is still working on its proposal to postpone the date of application for the Medical Device Regulation. The aim is to present a text to the European Parliament and the Council at the beginning of April, which could be adopted by the end of May.

Background information

The date of application for the Medical Device Regulation (EU) 2017/745 is 26 May 2020. The aim of the EU Medical Device Regulation is to ensure that patients in Europe are provided with safe, effective and efficient medical devices and that significant medical device ‘scandals’ no longer occur. The Regulation sets new standards for patient safety. We last reported in October 2019.