Medical devices (MDs) cover a wide array of products, from sticking plasters, to dental filling material, to heart valves and X-ray machines. In vitro diagnostic medical devices (IVDs) range from pregnancy self-tests, to blood-glucose meters, to state-of-the-art analytical laboratory equipment. There are over 500 000 devices on the market in the EU. The industry employs 575 000 people in about 25 000 companies, of which 95% are small and medium-sized enterprises (SMEs).
The EU legal framework relating to MDs and IVDs was harmonised in the 1990s. Given the fact that these devices have become increasingly sophisticated and innovative, the European Commission has considered it necessary to adapt existing rules to technological and scientific progress, improve the safety and traceability of devices, and ensure greater transparency, including for patients/users and the general public. The need for a revision was further reinforced by the breast implants scandal of 2010, in which a French manufacturer (Poly Implant Prothèse, PIP) had apparently used industrial silicone for the manufacture of breast implants for a number of years, potentially harming thousands of women worldwide.
Against this background, the Commission decided to undertake a revision of the current legislative framework. On 26 September 2012, it presented a package consisting of two proposals for regulations: on medical devices ('MD proposal') and on in vitro diagnostic medical devices ('IVD proposal'), accompanied by a communication. Both proposals have common horizontal aspects, but their specific features require separate legal acts.
The legislation is complex, wide-ranging and highly technical, and has been debated for nearly four years. The European Parliament adopted its position in first reading on 2 April 2014, the Council agreed on its general approach on 5 October 2015. Interinstitutional trilogue negotiations between Council, Parliament and Commission started on 13 October 2015 and were concluded at the tenth meeting on 25 May 2016.
The current EU regulatory framework consists of three different pieces of legislation: for medical devices, it is Council Directive 90/385/EEC on active implantable medical devices ('AIMD Directive') and Council Directive 93/42/EEC on medical devices ('MD Directive'); for in vitro diagnostic medical devices, it is Directive 98/79/EC of the European Parliament and of the Council ('IVD Directive').
Unlike medicinal products, MDs and IVDs are not subject to a pre-market authorisation, but to a conformity assessment. Conformity is assessed by 'notified bodies' – public third-party organisations or private companies designated by the Member States. These bodies issue a certificate of conformity ('CE' mark) for all but low-risk devices,1 the certification of which is handled by their manufacturers.
According to the Commission, the existing framework for regulating medical devices has proven its merits and is not fundamentally unsound. The revision aims to address anumber of weaknesses, such as differences in Member States' interpretation and application of rules, as well as regulatory flaws and gaps in regard to certain devices.
This is to be pursued within the overall objective of guaranteeing a high level of protection of human health and safety, ensuring smooth functioning of the internal market, and providing a regulatory framework that supports innovation and the competitiveness of the European medical device industry.
The main focus of the proposals is on the pre-market scrutiny and post-market surveillance of devices, and on their traceability along the supply chain.
The announcement can be found here by following this link.
Showing posts with label MDD. Show all posts
Showing posts with label MDD. Show all posts
16 June, 2016
27 September, 2013
EU Commission proposed new rules on in-vitro diagnostic medical devices
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. The existing regulatory framework for in vitro diagnostic medical devices has demonstrated its merits but has also come under criticism in recent years.
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.
The Commission proposes important changes regarding various aspects relevant for the life-cycle of medical devices, such as the scope of the legislation, the pre-market assessment of devices, their control once on the market, the transparency of data concerning marketed devices and the management of the regulatory system by the authorities. The main changes in detail are:
• Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests;
• Stronger supervision of independent conformity assessment bodies (so called 'notified bodies') by national authorities;
• More powers for notified bodies vis-à-vis the manufacturers, to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites;
• Clearer rights and responsibilities for manufacturers, authorized representatives, importers and distributors, including in the case of diagnostic services and internet sales;
• Extended database on medical devices (Eudamed), providing comprehensive and public information on products available on the EU market;
• Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns (e.g. recalls);
• Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices.
• Adaptation of the general health and safety requirements, including labelling provisions, to the technological and scientific progress.
• Introduction of classification rules that divide the broad range of in vitro diagnostic medical devices into four different risk classes as it already exists for other medical devices.
• Creation of a Medical Device Coordination Group composed of members representing national competent authorities in the field of medical devices to ensure better coordination between Member States, with the Commission providing the necessary scientific, technical and logistic support.
Medical devices and in vitro diagnostic medical devices produced in a third country and imported into the EU are subject to the same rules as medical devices produced within the EU.
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.
The Commission proposes important changes regarding various aspects relevant for the life-cycle of medical devices, such as the scope of the legislation, the pre-market assessment of devices, their control once on the market, the transparency of data concerning marketed devices and the management of the regulatory system by the authorities. The main changes in detail are:
• Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests;
• Stronger supervision of independent conformity assessment bodies (so called 'notified bodies') by national authorities;
• More powers for notified bodies vis-à-vis the manufacturers, to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites;
• Clearer rights and responsibilities for manufacturers, authorized representatives, importers and distributors, including in the case of diagnostic services and internet sales;
• Extended database on medical devices (Eudamed), providing comprehensive and public information on products available on the EU market;
• Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns (e.g. recalls);
• Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices.
• Adaptation of the general health and safety requirements, including labelling provisions, to the technological and scientific progress.
• Introduction of classification rules that divide the broad range of in vitro diagnostic medical devices into four different risk classes as it already exists for other medical devices.
• Creation of a Medical Device Coordination Group composed of members representing national competent authorities in the field of medical devices to ensure better coordination between Member States, with the Commission providing the necessary scientific, technical and logistic support.
Medical devices and in vitro diagnostic medical devices produced in a third country and imported into the EU are subject to the same rules as medical devices produced within the EU.
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