Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Advantages, disadvantages and pitfalls in current registration procedures of medical devices

Stefan Kuhn (Abschlußjahr: 2013)

Summary

Language: English

The present thesis deals with the current Medical Device Directive (MDD) and its revised version in the light of the PIP silicone breast implant case. The current version of the MDD will be transformed into a regulation according to the proposals of the Commission.

Beyond this basic change of its legal form the revised version contains a number of innovations regarding the assessment and monitoring of medical devices of high risk classes. The placing on the market of medical devices in the EU currently follows the "new approach-concept" which is characterized by a high degree of manufacturer's responsibility and by a decentralized conformity assessment procedure.

Experiences with some high-risk class medical devices in recent times, however, have disclosed some weaknesses in the system. Based on the events of the case of silicone breast implants by the French company Poly Implant Prothèse, many of these system weaknesses have been identified. The proposed Medical Device Regulation is characterized by countermeasures and includes the renunciation from "new approach concept" as basic common direction. The harmonization of the Notified Bodies' designation and monitoring of their conformity assessments by the centrally organized Medical Device Coordination Group of the Commission are important changes concerning the role and the supervision of the Notified Bodies. On the base of obligations, unannounced site inspections including tests with samples obtained directly from the production processes as well as the evaluation of vigilance data and the use of their results in audits will be tasks of the Notified Bodies. Also authorities will conduct periodic inspections and test samples.

In regard to the vigilance and market surveillance the PIP case revealed significant lacks concerning the availability of information of products on market and differences of notified incidents data in the Member States.

This has led to confusion and 2 years have been needed to get reliable data of patients concerned. To prevent such failures and to improve the current status, the proposed Medical Device Regulation provides a future central vigilance database and the obligation to introduce a system assuring product traceability and identification of patients concerned.

The proposed revised version of the Medical Device Directive leaves the "new approach" in order to avoid pitfalls and weaknesses of the current Directives and to strengthen the objectivity of conformity assessments by central entities (e.g. MDCG, joint assessment team).
The revision will be a big challenge for NBs, authorities and the Commission concerning recourses (manpower, equipment, competence).

By changing from "new approach " to "central approach" the threat of approval delays similar to the PMAs will have to be considered. After implementing of all proposed measures author's assumption is the repeat of a "PIP case" is unlikely.