On 25 September the European Parliaments’ Committee for the Environment and Public Health (ENVI) approved stricter rules on medical devices in order to protect the patients.
27 September, 2013 – Stricter rules on medical devices such as a new pre-market approval system, more transparency and better traceability were voted on ENVI Committee last 25 September.
Clear rules were introduced by Members of the European Parliament (MEPs) to boost public access to clinical data, create a new advisory body of experts and to improve the transparency amongst notified bodies as well as for manufactures.
A new approach to label medical devices was as well approved, dismissing doubts concerning reprocessing of single-use devices and reprocessing of reusable devices.
Concerning In Vitro diagnostic medical devices, more severe rules were well received on informed consent, genetic counselling, ethics committee and the involvement of minors and incapacitated people in clinical studies. Such devices are for example the HIV and DNA testing.
The new legislation proposal aims to ensure patient safety and avoid any unnecessary risk to patients like the PIP breast implant. As stated by the rapporteur Dagmar Roth-Behrendt (S&D, DE), “we have achieved our main objective: patients will be better protected from defective products. We were able to enforce our goals and to be more ambitious than the Commission proposal”.
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20 September, 2013 – One day prior to the European Parliament’s ENVI Committee vote the European Commission adopted two new rules on the functioning of notified bodies. The main objective is to strengthen consumer safety and improve the safety of medical devices.
Stricter rules are needed to regulate the 80 notified bodies for medical devices in the European Union. “With today’s measures the European Commission further strengthens the safety of medical devices. We now have a clearer basis for unannounced audits, sample testing, or joint assessments by notified bodies. Full clarity can only be achieved through amending the basic legislation” stated EU Commissioner for Consumer Policy, Neven Mimica upon adopting the new rules.
The new rules are (1) [Commission Recommendation on the audits and assessments performed by notified bodies in the field of medical
devices->http://ec.europa.eu/dgs/health_consumer/docs/recommendation_ip-13-854_en.pdf], which facilitate the consistent application of the conformity assessment provisions contained in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC; notified bodies should apply the provisions of this Recommendation when they perform product assessments, quality system assessments and unannounced audits; and (2) Commission Implementing Regulation on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices which intents to clarify the criteria to be met by notified bodies.
EPHA believes that the enforcement of those new rules represents another step forward to increase patient safety and restore trust amongst consumers.
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For more information please visit:
- EC press Release – Strengthening Consumer safety: Improving the safety of medical devices.
- ENVI Press Release -Health MEPs call for stricter controls on medical devices
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