European Association for Medical Device Reprocessing

Lack of Consistent Regulation

Improved safety through a Europe-wide regulation

The largest single obstacle to a European solution to this problem is the lack of consistent regulation across Europe. Each country has a different approach to the safe reprocessing of medical devices. At the moment, different national regimes are in place, varying from relying upon the manufacturers’ declaration of the device as single- or multiple-use, which corresponds to a factual prohibition (e.g. France or Spain), to tolerance of reprocessing (albeit in the absence of a suitable framework, e.g. UK), to regulation and supervision (as is the case in Denmark, Germany and the Netherlands). 

Not only does this increase costs and risks, as discussed elsewhere on this website, it also makes it very difficult for national administrations to gain a clear understanding of the existing possibilities and restrictions, both from technical and legal perspectives. 

EAMDR’s most urgent task, therefore, is to demonstrate that professional reprocessing means interlinking patient safety and cost effectiveness. Our various activities aim to improve the understanding and communication of the issue and the potential benefits of change, and to debunk the myths surrounding the safety aspects. EAMDR believes that the development of consistent EU legislation will enhance patient safety whilst paving the way for significant cost savings in the health sector as well as securing ecological improvements throughout Europe. Only binding quality standards and validated procedures offer convincing solutions since label categories do not serve as an appropriate link for regulation.

We hope that the consultation process will eventually generate enough political consensus and pressure to bring about the suggested amendments to the European regulatory framework, and the consequent rollout in the various Member States of the European Union.  EAMDR will demonstrate during the consultation process that professional reprocessing means interlinking patient safety and cost effectiveness.

We regularly publish a newsletter to inform our members about the issues surrounding the reprocessing debate and on the status of the EU consultation process. For a news update, please visit our news section by clicking here. To join EAMDR and receive our newsletter, see this page. If you have further questions, please do not hesitate to contact us at