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 Statement on the ongoing implementation of the Medical Device Regulations

When asked about medical devices shortages in the 2023 EAHP shortage survey, 61% of respondent hospital pharmacists reported challenges accessing medical devices in their hospitals. The most common causes given were; supply chain problems, shortages or discontinuance of component, part or accessory of medical devices, and price of a medical devices, while the implementation of the MDR and IVDR was the fourth most common response for hospital pharmacists.

Therefore, shortages of medical devices continues to be a reality throughout Europe and EAHP agrees that short-term measures are necessary to address pressing issues to ensure continued and timely access, including on:

• Improving the limited availability of orphan and paediatric devices;
• Ensuring the access to well-established technologies for which no health risks have been identified;
• Clarifying the notion of similarity in the clinical evaluation; and
• Ensuring a swift roll-out of the fully functional EUDAMED platform.

However, these should be separate from the in-depth evaluation process of the MDR and IVDR which must take the appropriate time to fully assess the impact and appropriateness of any new measures. EAHP welcome the European Commission’s decision to conduct a thorough evaluation of the impacts of the MDR and IVDR and call upon policy makers to wait for the results from the evaluations to have a clear overview of the issues directly related to the implementation of the MDR and IVDR before performing any major legislative changes without due process. Public health and patient safety must remain at the core of the MDR and IVDR regulatory system.

The statement on the implementation of the Medical Device Regulations is available here.

Joint open letter to address the shortcoming in the revision of the MDR 

EAHP together with the BioMed Alliance, the European Patients Forum (EPF), and the European Hospital and Healthcare Federation (HOPE), published a joint open letter urging the European Commission to address critical shortcomings in its revision of EU Medical Devices Regulation. 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. 

In a letter addressed to President Ursula von der Leyen and Commissioner Olivér Várhelyi, the four organisations representing medical societies, patients, hospital pharmacists and hospitals outline three urgent priorities for the targeted revision of the MDR. These build on previous recommendations of the respective organisations and reflect a shared commitment to improving the EU regulatory landscape for medical devices: 

• Clarify clinical evidence requirements and make clinical evidence public  
• Improve consistency and create a central body for scientific co-ordination  
• Improve coordination to address safety issues  

A targeted reform is necessary to ensure the system is science-driven, transparent, and responds to patients’ and healthcare professionals’ needs.

The open letter is available here.

EAHP original and follow-up Statements on the Medical Device Regulation proposal 

As an impacted stakeholder EAHP took a particular interest in the discussions on the future regulatory regime for the assessment, use and vigilance of medical devices in Europe. The statement on the medical device regulation sets out the position of the Association on a range of topical discussions about the Commission’s September 2012 proposals  and its subsequent considerations in the European Parliament.

EAHP generally welcomed the Commission‘s proposals to improve post-assessment vigilance and traceability of devices, and to tackle the issue of inconsistent application of approval procedures by notified bodies. Whilst noting that devices cannot necessarily be considered in the same manner as pharmaceutical products, in view of the documented disparity in standards of assessment for high risk devices between the USA and Europe , concerns expressed by national device regulators withing Europe , and the need to ensure patient safety, we consider that the case for central authorisation of class III devices, as proposed in the draft report of the European Parliament ENVI Committee (April 2013) , is merited. 

Further information and the EAHP statement on the proposal is available here.

In light of the Implant Files reports, the EAHP released an Opinion on the Medical Device Regulations in February 2019 which reiterates some of the points made in the Association’s Statement on the Medical Device Regulation. In particular, the EAHP calls

• On all involved actors to ensure an effective implementation of the new Medical Device Regulations to improve patient safety.
• On the European Commission to ensure protection against the potential misuse of the Medical Device Regulations.
• For the encouragement of collaboration of healthcare professionals in the selection, procurement and evaluation of medical devices.

The Opinion on the Medical Device Regulations is available here.

EAHP further used the occasion of its Synergy Certification Course on Medical Devices to reiterate some of the considerations raised by hospital pharmacist in its statements.

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.