German industry not impressed by MDR progress

Although the proposals for easing the current regulatory burden on medical device manufacturers as a result of delayed implementation of the MDR announced on 9 December may go some way to avoiding the disappearance of many medical devices from the European market, German associations from various groups have expressed their concern in recent weeks.

Spectaris, the German medtech industry association for optics, photonics, analytical and medical technologies, representing around 400 member companies, has commented on progress with implementation of the MDR that it will “mean fewer companies and fewer innovations”, so the EU Commission must make changes. In an open letter to the Commission, Spectaris called for:

• Extending the validity of the Medical Devices Directive and Active Implantable Medical Devices Directive Certificates;
• Allowing conditional/temporary MDR certification for substantially changed and new devices in order that sponsors can finish compiling MDR-compliant evidence; and
• Abolishing the MDR’s warehousing deadline, thereby allowing the continued sale of existing devices beyond the May 2025 end-date – and avoiding the needless disposal of usable devices.

At least the first and third of Spectaris’s wish list appear to be in play after the 9 December EPSCO meeting.

In addition, new report from Germany’s H&Z Management Consulting group, issued during Medica 2022, reporting results from 400 medtech companies in Germany, Austria and Switzerland, concluded that “the fuse is burning at both ends”, with operational issues and higher costs causing delayed innovation, while increased regulation is affecting product sustainability.

The report’s key findings regarding increased regulation via the MDR include:

• Discontinuation of current products
• Innovation being jeopardized
• 19% increase in product launch costs
• 32% increase in time to reach development milestones

Independently, the German Hospital Federation (DKG) has also been making requests to the German government, citing an April survey that showed that many hundreds of important device were already not available on the German market. Representatives of 18 EU member states had already apparently reported device availability issues.

While patient safety remains the highest priority for all healthcare stakeholders, the patient safety benefits of the MDR, rather like the so-called Brexit benefits in the UK, are very difficult to pin down.