Medical devices are currently regulated under three main Directives covering respectively active implantable medical devices (AIMD), medical devices (MDD) and in vitro diagnostic medical devices (IVDD). In vitro refers to tests performed on samples - for example blood, tissues or urine - outside the living body and in an artificial environment.
Due to technical differences between the three directives, the Commission has decided against a merger of the directives. At the moment, better regulation will therefore be achieved through regulatory clarifications to ensure consistency of interpretation and implementation.
Medical devices comprise any instrument, appliance, software, etc. used for the purpose of disease prevention (e.g. vaccine-delivery devices), screening (e.g. mammography for breast cancer), diagnosis (e.g. use ultrasound system) or treatment or alleviation of disease. Recent public concern about breast implants, dialysers etc. shows that the medical devices sector represents a high profile activity and that the public expects enhanced safety standards.
The European market for medical device technology is the world’s second largest (US: 37%, EU-15: 26%, Japan: 15%) and was valued at 41 billion euro in 2002. In recent years, the sector has suffered losses in world market share and employment, mainly due to market consolidation and significantly lower European expenditure on healthcare (5.7% of GDP in EU-15 compared to 13.9% in the US and 7.1% in Japan).
In June 2002, the Commission’s Medical Device Experts Group (MDEG) produced a report on the functioning of Directives on Medical Devices. According to its findings based on discussions held with stakeholders and responsible authorities in the member states, it concluded that whilst the Medical Devices Directives provide an appropriate legal framework, there was room for improvement in implementation of the directives by all interested parties, including industry. The main areas needing improvements were:
- borderline issues (medical devices incorporating a medicinal substance in a secondary role to the main mode of action of the medical device, including wound dressings containing a disinfectant, or contraceptive coated condoms);
- reuse of devices (member states' competence);
- proper implementation of clinical data;
- designation and monitoring of Notified Bodies.
The Commission published, on 12 May 2005, its draft review proposal for consultation. The Commission invited the public to comment on its draft proposal to amend the rules on medical devices (MDD) and on active implantable medical devices (AIMDD).
The Commission draft proposal considers relaxing confidentiality to allow certain information on all devices to be publicly available, thus improving transparency. It also proposes changes to the classification of medical devices.
Further, the proposed amendments are intended, among others, to improve:
- clinical evaluation, through clarification of the requirements,
- post market surveillance, to increase transparency for the general public,
- consistency between the medical devices and the active implantable medical devices directives,
- the decision-making process, by allowing binding decisions in case of conflicting national interpretations on whether or not a product is a medical device.
Eucomed, the European Medical Technology Industry Association, and COCIR, the European Coordination Committee of the Radiological and Electromedical Industry support the changes proposed in the Commission draft proposal.
However, their position paper points out a number of issues requiring further clarification. Namely, the 'evidence-based decision-making' -principle should be clearly anchored in the text of the Directive, the specificity of hybrid products should be taken into account and procedural duplications avoided and most of the amendments on the reclassification of medical devices should be withdrawn. The actors would also like to see the Directive to encourage the use of state-of-the-art information delivery systems for the instructions for use of medical devices.
Further, the paper recommends addressing the issue of reprocessing of 'single use' devices. The health associations have argued that the practice of reusing single-use medical devices by hospitals endangers the health and safety of patients as well as healthcare workers due to the risk of hepatitis and CJD (Creutzfeld-Jakob disease) infection. They say patients should be asked to give their informed consent to the reuse of medical devices originally designed for single use, taking into account the dangers of infection as well as the possibility of device malfunction.
The Standing Committee of European Doctors (CPME) recommends that any new legislative proposal on the medical devices legislation should improve the vigilance system, the tool currently available for the monitoring of the safety of medical devices. The CPME suggests that when a borderline problem occurs between pharmaceuticals and medical devices, the criteria for the classification of the products should favour the most secure regime, meaning the one on pharmaceuticals.
The European Association for Medical Device Reprocessing (EAMDR) wants the Commission to address the issue of medical device reprocessing, to ensure patient safety. "Medical device reprocessing has a strong impact on the quality of treatment of the patient, the safety of the medical device as well as the costs for treatment and purchase. The legislation should focus on the quality of reprocessing of medical devices rather than on the declaration of the medical devices by the manufacturer as single-use or multiple-use." EAMDR thinks that a European framework directive could thus enhance patient safety while at the same time create an internal market for reprocessing medical devices.
The European Federation of Nurses Associations (EFN) also calls on the EU to regulate all re-processing of medical devices intended for single use by hospitals, re-processors and original manufacturers, in order to protect the health and safety of patients and healthcare workers. EFN notes with concern that the Medical Devices Directive does not prohibit the reprocessing of single use medical devices and urges that this situation to be changed.