Following the Commission proposals for a Regulation on Medical Devices and on In Vitro Medical Devices released in September 2012, EPHA has developed a position paper highlighting, inter alia, the importance of the provisions related to patient safety; the responsibilities of the notified bodies, and improved traceability.
The EPHA Position on Medical Devices is supportive of the objectives - and legal format - of the Commission’s proposal which aims at ensuring a high level of human health and safety, efficient functioning of the Internal Market, as well as innovation in medical technology for the benefit of patients and healthcare professionals.
As also expressed in the EPHA Briefing on Medical Devices, patient safety must be at the heart of the revision; this includes striking the right balance between harmonisation of rules and decisions to be taken at Member State level to make certain that the shortcomings of the current system – including very diverging competences and activities of the notified bodies, and different requirements for manufacturers – will not repeat themselves, and that substandard products do not obtain certification.
Concerning the scope of the proposal, the extension to other products such as implants for aesthetic purposes is to be welcomed. However, EPHA feels that more clarity is required on what products are excluded from the scope, and regarding the requirements to be met for medical devices received by patients treated abroad.
EPHA also welcomes improved traceability of medical devices by way of a system that would include a Unique Device Identification (UDI) based on international guidance, as well as improved registration of devices and a European databank. Moreover, safety reporting must be stepped up and it should be mandatory for manufacturers to report serious incidents at EU level. These measures shall ensure a high level of safety and a more transparent system, and also help restore patients’, consumers’ and healthcare professionals’ confidence.
There should also be stricter supervision of notified bodies by Member States, as well as more control of notified bodies over manufacturers, including unannounced factory visits. The independence and quality of pre-market assessments must also be assured. Conducting conformity assessments prior to placing devices on the market should prevent problems such as those experienced during the PIP breast implant debacle.
Adequate funds must also be available for upgrading and setting up the required IT infrastructure and hiring additional staff, and for ensuring the good functioning of expert groups, especially should it be intended to include the views of patients, health professionals and civil society representatives who may require additional training. To increase transparency and ensure ‘’real-life’’ practicability, the Regulation should foresee a role for these groups.
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