EU Council and Parliamentary Committees endoreses new MDD & IVD directives

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.

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.