Medical Device Legislation Update


The Commission Formal Proposal published in September 2012 is expected to be adopted as new legislation by the end of next year, 2015. The final shape of the legislation is far from decided at this point in time and what will finally emerge will probably be quite different from what we have today.

One of the significant changes is that the role and number of Notified Bodies will be different. They will be expected to carry out unannounced audits at least once every three years and more frequently for high risk products. Manufacturer’s critical suppliers will also be subjected to this process.

Processing of single use devices remains a difficult area. All credit to the Commission for an attempt to bring this into line using the fundamental principal that anyone who reprocesses a device must take on the full responsibility of the manufacturer. Some member states are resisting this and the European Parliament (EP) are making things worse by proposing that all devices are reusable by default.

The system proposed for clinical investigati9ons will also add to manufacturer’s costs with the EP proposing randomized controlled trials (RCTs) for devices. A lot of work is needed to convince people that this is not appropriate. A recently published Commission report in the Joint Action Plan calls for and implements improvements to the system in advance of the new legislation. This includes the unannounced audits by Notified Bodies mentioned above but also addresses issues around vigilance and post market surveillance, a key area which was identified as central to any improvement as far back as the 2008 report. This is being actively addressed across the EU with major Competent Authorities, including the HPRA taking a lead. Improvements here are key to a better system in the future but don’t forget that it will also mean more cost all round.

One major change which flows from more general EU legislation is the greater control that will be imposed on players in the supply chain (knows as Economic Operators). This will mean that the activity of importers and distributors will now come under greater scrutiny and surveillance. Each actor in the supply chain will need to verify compliance with his supplier. Industry is trying to ensure that this is done in a sensible way, resisting calls for complicated labelling regimes. In a related area the rules on own branding will almost certainly change meaning that those selling a products under their own name (but made by someone else) will face significant extra costs.

UDI is a key component of the proposed new legislation on medical devices and is seen by many in the broader healthcare community as the answer to a wide diversity of problems. Many, including those working on the legislation, see it as a ‘done deal’; something which will be implemented in the fullness of time. Unfortunately this is not the case. On both UDI and the closely related question of the EU Database, there are instances of deviation and non-conformance by member states.