In summer of 2011, the EU’s Central Management Committee’s (CMC) published “Decision No 3”, requiring the placement on medical devices of the full postal address of manufacturers and authorised representatives. Since then, Decision No 3 has had the European medtech industry scratching its head in confusion. As we see it, the adoption of the decision has already led to great legal uncertainty, and implementing it in its current form would serve only to increase bureaucracy and additional, unnecessary costs.
Since the publication of the decision, Eucomed has shared its views with the CMC, as well as with key stakeholders like the European Commission and the Compliance and Enforcement Group (COEN). Information was collected to substantiate our position with the help of many of our members, especially the German medical technology association BVMed, who has joined us in calling for a constructive dialogue with a view to quickly turn multilateral perspectives into a shared inclusive view.
With Decision No 3 on labelling, the CMC aims to improve transparency, uniformity and patient safety. These goals also all lie at the centre of Eucomed’s core values. We do believe however, that there are simpler, more legally certain alternatives available to achieve these important objectives. The Eudamed European database for medical devices, for example, should contain all the required information on devices, manufacturers and authorised representatives and is easily accessible to health authorities. Unique Device Identification is also on the horizon—and should in the future serve as a means to provide all the information required (including address information), for every medical device via a database.
The adoption of the Global Harmonization Task Force (GHTF) labelling guidance could also be an acceptable solution. The GHTF guidance for Label and Instructions for Use for Medical Devices specifies that the label should contain particulars which may appear on the medical device itself, on the packaging of each unit, or on the packaging of multiple devices. These details include “The name and address of the manufacturer in a format that is recognisable and allows the location of the manufacturer to be established”. The guidance goes on to specify that “an abbreviated version of the address may be sufficient on the label if the device is accompanied by instructions for use that provide a full address.” Certainly, taking the GHTF route should at least be food for thought.
Whichever measure is ultimately adopted—the decision must be taken within the EU legal framework, according to established rules and after proper multi-stakeholder consultation. The tools available under the Medical Device Directives guarantee proportionality, more coherence with other EU rules, and would be beneficial to creating a balanced and clear decision with a realistic implementation timeline.
So where do we stand now? It seems that very recently the European Commission Directorate General for Health and Consumers itself has taken up the issue in writing to the CMC. The CMC has recently stepped up efforts to engage with stakeholders on the specifics of its work programme. We very much welcome this and believe it is a genuine sign that all players agree that we need to move forward as soon as possible on a solution that makes sense for all—a solution that makes use of existing structures and regulations to keep patient safety at the heart of the matter.
– Merlin Rietschel, Manager Regulatory & Technical Affairs, Eucomed