Medical devices are an essential part of the delivery of high quality healthcare and their procurement and management in the European hospital setting is often under the authority of hospital pharmacists.

EAHP opinion on the revision of the Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation

Shortages of medical devices continues to be a reality for many hospital pharmacists. In the 2025 EAHP shortage survey, 53% of hospital pharmacists reported that it was a problem in delivering the best care to patients within their hospitals. To address these challenges, the proposal for the revision of the MDR and IVDR introduces changes with the aim to make the legislative framework easier, faster and more effective. EAHP welcomes the proposal’s intent to simplify the rules without reducing the safety of medical devices.

EAHP especially welcomes the measures of the proposal on:

• The inclusion of the definition for well-established technologies, breakthrough devices, and orphan devices within the legislation and their respective measures to improve access.
• The amendments to in-house devices allowing their transfer between health institutions in specific cases and reduction of administrative burden.
• The extended role of the EMA and increased responsibilities of the expert panels.

• Ensuring that hospital pharmacists are notified sufficiently in advance in case of interruption or discontinuation of supply.
• Improving the access and use of the summary of safety and clinical performance.
• Ensuring that the removal of the 5-year limitation to the medical device certification does not lead to reduced safety of the devices available on the market.
• High-risk AI medical devices should not be exempted from the requirements under the AI Act due to their specificities not being covered under sectoral legislation.

• EAHP statement on the implementation of the medical device regulations outlining key short term measures to address pressing issues, ensuring continued and timely access. The statement published in 2025 is accessible here. 
• EAHP together with the BioMed Alliance, EPF and HOPE published a joint open letter to address the shortcoming in the revision of the MDR. While the group welcomes the intended purpose of the Regulation to enhance safety of devices in Europe, there are certain issues that must be addressed including a lack of pathways for orphan and breakthrough devices, limited transparency, and limited coordination and oversight. The letter published in 2025 is accessible here.
• EAHP published its opinion following the adoption and implementation of the MDR in 2019 accessible here.
• EAHP published its statement on the original MDR proposal in 2013 accessible here.

Medical device resources for hospital pharmacists

In many European countries, hospital pharmacists are responsible for the handling of medical devices. To support their work, EAHP has joined forces with EURO-PHARMAT, one of the Association’s members based in France whose work focuses on medical devices. Together with EURO-PHARMAT, a list of medical device resources was created to assist hospital pharmacists dealing with medical devices across Europe.