The European Association of Hospital Pharmacists (EAHP), an association of national organisations representing hospital pharmacists at European and international levels, has published a policy statement on the issue of medical device regulation in Europe.
It is intended as a contribution to the current discussion between the European Parliament and European Commission on the subject of device assessment authorisation, vigilance and traceability. 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 has reviewed the September 2012 proposals of the European Commission to update pan-European device regulation, and followed the scrutiny of the European Parliament on the subject.
Subsequently EAHP’s members have passed policy to: support central authorisation of high risk (class III) devices as a proportionate measure to ensure high level scrutiny of device safety; call for explicit coordination between future verification and traceability systems for devices, and the systems for medicines verification already in development as a result of the Falsified Medicines Directive; and request harmonisation between the processes for vigilance reporting by health professionals in respect of medical devices and existing systems of pharmacovigilance.
EAHP is concerned about evidence that device approval standards have been inconsistently applied by Europe’s national level approval authorities (or ‘notified bodies’), as well as disparity in standards of assessment for high risk devices between the USA and Europe. Whilst EAHP recognise that devices cannot necessarily be considered in the same manner as pharmaceutical products, the Association views that a distinctive case for centralised authorisation procedures for Class III devices exists (i.e. those devices that support or sustain human life).
Furthermore, EAHP promotes joined-up thinking on device and pharmaceutical regulation. With new traceability, verification and vigilance systems now being put in place across Europe for pharmaceuticals (Pharmacovigilance and Falsified Medicines Directives) there is a need to avoid unnecessary duplication and ensure interoperability wherever possible in respect of similar developments planned for device regulation.
EAHP President Dr Roberto Frontini said: “Good regulation can often be a difficult balancing act between protecting patient safety whilst also promoting innovation. In this sense I cannot see a case for centralised authorisation for all medical devices. Yet where a device fits within the category of Class III – high risk – another level of assured scrutiny is needed. From assessing the options, EAHP consider that centralised authorisation offers the best opportunity for a transparent, rigorous and well understood process. With discussions on the subject continuing EAHP will seek to ensure that the practice experience hospital pharmacists have with devices contributes positively to the final regulation.”