MEPs vote for tighter controls of medical devices

On 25 September 2013, the European Parliament’s Committee on Environment and Public agreed to tighten up requirements on organisations that check the conformity of medical devices. MEPs call for a system of double surveillance for the riskiest devices with the creation of special bodies and a Commission expert committee.

Currently, medical devices are placed on the market without having to obtain prior authorisation apart from manufacturers having to demonstrate that their product meets European standards by affixing the CE (European conformity) mark obtained from one of 80 European bodies. However, recent incidents (e.g. the PIP breast implant scandal) led the Commission to propose to strengthen EU rules by replacing the regulations on medical devices and in vitro medical devices.

MEPs also strengthen the patient’s role and the provision of information to patients. For example, manufacturers must be obliged to take out civil liability insurance at a level sufficient to cover any injury caused to the patient. In relation to in vitro diagnostic devices the Committee requests the involvement of an ethics committee and introduces provisions on informed consent and genetic counselling.

Unlike the industry, organisations of patients EPF), doctors (CPME) and mutual societies (AIM) welcome the outcome.

The European Parliament will vote the proposal in plenary on 22 October.

For more information:

http://www.europarl.europa.eu/meetdocs/2009_2014/organes/envi/envi_20130925_0900.htm