Background information on devices regulation and potential statement

 

Related to GA Agenda item 9.5

 

Background

Since the revelations of the PIP breast implant scandal the debate about the robustness of current mechanisms for medical device regulation in Europe have taken on an added urgency.

Responding to the PIP concerns about poor traceability procedures for devices and lack of powers for notified bodies to conduct unannounced inspections of device manufacturing sites, as well as more generally expressed concerns about differing standards of assessment being applied by Europe's 80 notified bodies with the ability to grant devices European-wide CE marks, the European Commission published proposals for improving device regulation in September 2012. More information here. 

The proposals are wide ranging across the areas of device assessment, vigilance, and traceability. In summary however, they:

• introduce new procedures to enable notified bodies (and the European Commission) to scrutinise each other's assessment procedures and decisions
• enable Notified Bodies to conduct unannounced inspections of medical device manufacturing premises
• extends the information contained on the EUDAMED database, including in relation to vigilance issues and clinical investigations
• introduces new conditions for the reuse of single use devices
• places new requirements for the role of qualified persons during manufacturing of devices
• sets conditions for parallel trade of medical devices (repackaging and relabelling)
• introduces new requirements for manufacturers to fit devices with Unique Device Identification 

The European Parliament has commenced its scrutiny of the proposals, with the lead scrutiny Committee being ENVI (health), in turn led by Dagmar Roth-Behrendt (Germany, Socialist Group). Ms Roth-Behrendt published her draft report in April 2013 with a major area of disagreement with the Commission being her suggestion that high risk devices (class III) should be subject to a centralised authorisation procedure, similar to that which exists for medicines.

This call for central authorisation procedures for high risk devices is supported by a diverse range of organisations including the European Consumers Organisation, the European Federation of Nursing Organisations, the European Social Insurance Platform, the International Society of Drug Bulletins and the Medicines in Europe Forum. More information here. 

Commentators expect a drawn out disagreement with the Commission on this point, potentially meaning the reform proposals will not pass by the end of the European Parliament's term in Spring 2014.

 

Suggested statement by EAHP 

According to the 2010 EAHP Survey of Hospital Pharmacy Practice, medical devices are selected by 55.8% and purchased by 56.2% of hospital pharmacies (more information here). Therefore, not only does hospital pharmacy have a stake in the development of this area of regulation, but the role of the hospital pharmacist in this area merits further profiling and awareness raising.

Following discussion in the Board, the proposed EAHP statement:

• supports the suggestion of central authorisation of high risk devices
• coordination between future systems of device traceability and future medicines verification systems
• coordination of vigilance reporting mechanisms for devices and medicines
• the need to ensure device regulation cannot be used as a means of bypassing the rigour of medicines regulation (e.g. combination products, dialysis solutions etc)

Draft statement here.

* Members may propose further amendments to this statement until the close of Friday 24 May. Please email these to richard.price@eahp.eu