Medical device law: Are changes to the Medical Device Regulation imminent?

Calls from politics and industry for further amendments to the MDR are getting louder and louder, which is why we would like to summarize the current discussion below.

A brief overview of current developments

The Medical Device Regulation (MDR), which has been in force since May 2021, continues to pose major implementation problems for the medtech industry. A recent survey shows, among other things, that the increased regulatory requirements are leading to considerable cost and bureaucratic burdens, loss of innovation and extended approval procedures.

Due to the long (re)certification processes, the MDR was last amended by Regulation (EU) 2023/607, which came into force on March 20, 2023, with regard to transition periods, among other things. While the risk of production stoppages and supply bottlenecks seemed to have been partially eliminated at the time, at least in the short term, the tense market situation has now led to renewed discussions about amending the MDR.

On December 12, 2023, the CDU/CSU parliamentary group submitted a motion to the German Bundestag, which will be the subject of a debate in the Bundestag on January 18, 2024 and will then be referred to the Health Committee for further discussion. The motion essentially calls for a reduction in bureaucracy, faster approval procedures, security of supply and strengthening Germany as a location for innovation and business.

However, changes to the MDR cannot be implemented at federal level. This depends on the EU institutions. But there is now also movement at EU level. On January 10, 2024, German MEPs Peter Liese and Angelika Niebel presented the EPP Group with a 10-point list of demands to amend the MDR. The proposal largely overlaps with the Union's proposal in Germany.

Essentially, the list of demands includes the following points:

• Maintaining the current safety and quality standards
• Special rules for niche products (e.g. orphan device regulation analogous)
• Accelerated approval procedures for ground-breaking products ("fast-track" process)
• Systematic revision of MDR and IVDR regulation to reduce bureaucracy
• Abolition of the 5-year recertification for low-risk products
• Early evaluation of the MDR in 2025
• Revision of the qualification criteria for the Responsible Person
• Strengthening the capacities of notified bodies and speeding up procedures
• Promotion of an effective governance system
• Further postponement of the transition period

Outlook

In view of the increasing criticism from the MedTech sector, the current discussion in the German Bundestag and at EU level, a renewed amendment of the MDR cannot be ruled out. Companies operating in this field should therefore keep an eye on current developments in order to be able to react to any legal changes in good time.

Update

The debate on the Union parliamentary group's motion scheduled for January 18, 2024 has been removed from the Bundestag agenda. The reason for this is probably the latest developments at EU level. On January 23, 2024, the EU Commission announced a proposal for the third MDR/IVDR amendment to the European Parliament and the Council. This is intended to improve security of supply and essentially contains the following points:

• Manufacturers of in-vitro diagnostics are to be granted more time under certain conditions to comply with the new requirements of the Regulation on in-vitro diagnostics (IVD Regulation).
• The gradual introduction of the European Database on Medical Devices (EUDAMED) is to be accelerated.

The introduction of an obligation for manufacturers to report possible supply shortages of in-vitro diagnostics or medical devices should lead to better planning and risk assessment by authorities and healthcare facilities.

If you have any questions, please do not hesitate to contact us.