Italy: Brief Analysis Of The Proposed Changes To The Medical Device Directive 93/42/EEC

I. Medical Devices In Europe.

The EU Commission well understands the strategic importance of the medical device sector for Europe. Europe is the second-largest world market for medical devices, and about 8,000 types of devices are on the Community market. Additionally, the medical device sector, a highly innovative industry, is recognized as having a crucial impact on the quality of life of European patients, and impacts health care and health policy.

II. Legal Framework.

The basic legal framework on medical devices was laid out at the Community level during the 1990s. Three main directives have been enacted, in the following three fields:

• Directive 90/385/EEC on active implantable medical devices;
• Directive 93/42/EEC on medical devices ("MDD"); and
• Directive 98/79/EC on in-vitro diagnostic.

Other Directives in this area include Directive 2000/70/EC, on medical devices incorporating stable derivates of human blood or human plasma, and Directive 2003/32/EC, on medical devices manufactured utilizing tissues of animal origin.

This article focuses on the MDD and on the changes that the Commission is considering adopting to improve the regulation of the medical device sector.

III. The Medical Device Directive.

The MDD is based on the principles of the so-called "New Approach" to technical harmonization and standards. In accordance with the New Approach, the MDD does not analytically specify the technical features that medical devices must possess, but instead defines the essential requirements that devices must meet in order to be marketed. This approach appeared more appropriate for the regulation of rapidly evolving technologies, whereas a detailed specification of the devices’ features would have necessitated a constant update of the applicable provisions to describe the ever-changing state of the art.

Under the MDD, devices are subdivided into four categories, depending on the potential risks that are associated with their use. Assessment procedures for Class I devices are based on the manufacturer’s evaluation only, while Class IIa, IIb and III devices may be marketed only after a specific, so-called "Notified Body" has inspected them.

IV. CE Marking.

Manufacturers of medical devices must perform a risk/benefit analysis regarding any device, reduce risks to the minimum, adopt any adequate safety measure, and fully inform users of any remaining risk. Compliance with this required conformity assessment results in the issue of the CE mark, without which marketing of the device is not allowed. Only devices intended for clinical investigations and custom-made devices can be placed on the market without any CE marking.

The CE mark serves the purpose of certifying compliance with the MDD and allows the device to freely circulate within the Community market. Under the "safeguard clause," however, Member States are entitled to take appropriate interim measures to prohibit or restrict the circulation of certain devices on the market when they may compromise the health or safety of patients or other users. As measures taken under the safeguard clause represent an exception to the free circulation of devices on the European Market, they are reviewed by the Commission, which assesses whether they are justified in a particular case.

V. Proposed Changes to the Medical Device Directive.

Pursuant to Section 11(4) of the MDD, the Commission conducted a review of the regulatory framework and released a Communication to the Council and the European Parliament on Medical Devices, which was published on July 2, 2003 ("Communication").

While the present overall functioning of the regulatory framework appears to be appropriate, the Communication highlights a number of areas where improvement is possible.

A. Conformity Assessment. The Commission identified shortcomings in the conformity assessment, particularly in relation to the role of Notified Bodies, and suggests reinforcing the obligations to provide clinical data to Notified Bodies, their evaluation of the manufacturer’s quality system and of the data presented, as well as the provisions requiring market surveillance. Further, reclassification mechanisms for devices should be used more effectively. Lastly, designation and monitoring of Notified Bodies should be improved and the creation of a Notified Bodies Operations Group is suggested.

B. Transparency and Trust. There is a lack of transparent and easily accessible data on medical devices with respect to certifications by the Notified Bodies, and the European Database for Medical Devices (EUDAMED) has not been satisfactorily implemented. The Communication suggests the creation of "EU Notified Body public assessment reports" including selected information on devices, that would take due account of the legitimate interests of manufacturers. Further, communication must be improved between Member States and Notified Bodies, as well as among the Notified Bodies themselves. Information should be provided on a regular basis to the Health and Policy Forum, representing consumers, patients and healthcare professionals, and EUDAMED should be fully implemented.

C. Market Surveillance. The Commission expressed concern over the varied levels of market surveillance, and cooperation by Member States on this matter is highly encouraged. Also suggested are mechanisms to ensure early-warning exchanges between authorities, as well as communication to all Member States of measures restricting circulation on the market of medical devicesre.

D. Cooperation between Commission and Member States. The existing cooperation between the Commission and Member States has proved to be insufficient in politically sensitive areas, in the case of safeguard clauses, and in standardization. The Commission proposes the establishment of a high-level group on medical devices composed of EU Member States, candidate countries and EFTA, which would not jeopardize any other body active in this field (such as the Medical Device Expert Group).

E. Enlargement. The Commission hopes that implementation of the MDD in accession countries will be carried out with sufficient human resources, and recommends that such countries join the various working groups and participate in workshops, consultations and mentoring.

F. The International Dimension. Many Mutual Recognition Agreements (MRAs) covering medical devices have been signed, but only the ones with Switzerland and Australia are operational. The entering into force of MRAs should in any event be based on the existence of strict guarantees. The Global Harmonization Task Force (GHTF) is an informal group of representatives from national medical device regulatory bodies in Europe, Asia Pacific and North America that has gained more and more importance, and Europe should continue to play a leading role in the activities of GHTF.

The Communication further identifies a number of areas for regulatory modification, the main aim of which is defining new rules for conformity assessment and classification (e.g., elimination of certain classification anomalies, validity of conformity assessment certificates and retention of product files, clarifications on clinical evaluations), and at aligning the rules set in the Active Implantable Medical Devices Directive with the MDD.

Other measures recommended by the Communication include:

1. The launch of a study on the medical device sector;
2. The creation of a High Level Group allowing consultation between the Commission and national authorities;
3. Regular provision of information to the Health Policy Forum;
4. The creation of a pilot project on EUDOMED; and
5. That MDEG monitor the current practices in the areas of vigilance and standardization.

VI. Reactions and Conclusions.

The Communication generally has been well received by the industry. UEAPME (Union Europeenne de l’Artisanat et des Petites et Moyennes Enterprises) pointed out the importance of extending the reach of the MDD to third countries and of including custom-made medical devices in such efforts. In conclusion, it can be said that the Commission is not overlooking the importance of the medical device sector and is seriously taking measures to improve the safety of devices, as well as to ensure strict vigilance on the enforcement of the MDD’s rules and regulations.