Brussels, 22 October 2012

In a joint position paper, the Association Internationale de la Mutualité (AIM), the European Social Insurance Platform (ESIP), the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) argue that high-risk medical devices should be made subject to approval at European level, and that the rights of patients harmed should be improved.

> Click here to download the joint position paper (pdf)

Summary of the key proposals

Various scandals and serious safety problems have shown the failures and limitations of the CE (for “European conformity”) certification system for high-risk medical devices.

The revision of the European medical devices legislation is therefore a great opportunity to entirely overhaul the European authorisation and surveillance system for high-risk medical devices notably by making high-risk medical devices subject to a true market authorisation.

AIM, ESIP, ISDB and MiEF believe that the European Commission’s proposal of 26 September 2012, revising the medical devices legislation, are insufficient to ensure a high level of quality, safety and efficacy of medical devices entering the market. The Commission’s proposal provides solely for stronger monitoring once a device is brought onto the market.

Several issues need to be addressed:

1. The current certification system by private Notified Bodies remains insufficient in guaranteeing effective protection of patients
   • Several medical devices that were rejected in the US thanks to the federal preapproval system by the Food and Drug Administration were marketed in Europe, and then removed from the market for safety reasons.
2. A centralised approval procedure is required for high-risk medical devices
   • Instead of the current CE certification by private Notified Bodies, high-risk medical devices (i.e. class III or implantable devices) must be subject to a centralised approval procedure at European level, in which safety, efficacy as well as a positive risk-benefit balance must be proven by the results of high quality clinical investigations.
   • The results of clinical investigations should be stored in a publicly accessible central database.
   • For high-risk medical devices which are already in use, the procedure for re-approval set up in article 45 of the proposed Regulation – in which safety and efficacy have to be proven – should be provided for in the mid-term, in the context of the centralised approval of medical devices.
3. Rights of patients harmed need to be strengthened
   • To ensure adequate provision for coverage in case of harm, medical device manufacturers must be obliged to take out compulsory liability insurance including coverage of direct action by the injured party.
   • In the interest of patients harmed as well as in the interest of payers, a right of access to information held by medical device manufacturers as well as the supervisory bodies should be embodied in the law.
   • The burden of proof that a faulty device is / is not the cause of harm should be transferred from the patient to the manufacturer. The patient should only be required to demonstrate that it is objectively possible that the device may have caused the harm.

> Click here to download the joint position paper (pdf)

©Prescrire October 2012