The current EU regulatory framework for in vitro diagnostic medical devices ('IVDs') consists of Directive 98/79/EC of the European Parliament and of the Council ('the IVD Directive') IVDs cover a wide range of products that can be used for population screening and disease prevention, diagnosis, monitoring of prescribed treatments and assessment of medical interventions.
Like Council Directive 90/385/EEC on active implantable medical devices (AIMDD) and Council Directive 93/42/EEC on medical devices (MDD)3 the IVD Directive is based on the 'New Approach' and aims to ensure the smooth functioning of the internal market and a high level of protection of human health and safety. IVDs are not subject to any pre-market authorisation by a regulatory authority but to a conformity assessment which, for the majority of devices, is carried out under the sole responsibility of the manufacturer.
For the high-risk devices listed in Annex II and devices for self-testing, the conformity assessment involves an independent third party, known as 'notified body'. Notified bodies are designated and monitored by the Member States and act under the control of the national authorities. Once certified, devices bear the CE marking which allows them to circulate freely in the EU/EFTA countries and Turkey.
The existing regulatory framework for in vitro diagnostic medical devices has demonstrated its merits but has also come under criticism in recent years. In an internal market with 32 participating countries and subject to constant scientific and technological progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main objectives of the Directive, i.e. the safety and performance of IVDs and their free movement.
This revision aims to overcome these flaws and divergences and to further strengthen patient safety. A robust, transparent and sustainable regulatory framework for in vitro diagnostic medical devices that is 'fit for purpose' should be put in place. This framework should be supportive of innovation and the competitiveness of the in vitro diagnostic medical device industry and should allow rapid and cost-efficient market access for innovative IVDs to the benefit of patients and healthcare professionals.
This proposal is adopted alongside a proposal for a Regulation on medical devices that are currently covered by the AIMDD and the MDD. While the specific features of IVDs and of the IVD sector require the adoption of a specific legislation distinct from the legislation on other medical devices, the horizontal aspects common to both sectors have been aligned.
26.9.2012 (541) Final