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.

One step forward: unique device identification (UDI) system of medicaldevices in EU

Traceability is currently not regulated by MDD 93/42/EEC, nor by IVDD 98/79/EC or AIMD 90/385/EEC. EU Commission published the COMMISSION RECOMMENDATION of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union.

The Recommendation mainly discusses the Unique Device Identification (UDI) system for the better traceability of medical devices, active implantable medical devices and in-vitro medical devices.

The UDI should comprise two parts, a device identifier and a production identifier, and the system should be implemented gradually, starting from Class III.

Not only manufacturers should keep a close watch to the development and implementation of the UDI system, but importers, EU Authorized Representatives as well as distributors should also be involved.

The implementation date of the UDI System is not clear so far, but this Recommendation is obviously a step forwarder towards the target.

A copy of the recommendation can be downloaded here.

Guidelines on Medical Device Vigilance System Rev 8 released

Revision 8 of MEDDEV 2.12-1, Guidelines on a Medical Device Vigilance System, was released in January 2013, which will be applicable as from July 2013.

This revision's explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual.'

A copy of this revision can be downloaded here.

Council Directive 90/385/EEC on Active Implantable Medical Devices

Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices could be downloaded here for reference.

Click to download