Implementing regulation 2013/920 - Designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices - Main contents

EN

Official Journal of the European Union

L 253/8

Technical progress has led to more complex devices and production methods implying new conformity assessment challenges for notified bodies. Those developments have resulted in variations in the level of competence of notified bodies and in different degrees of stringency applied by them. Accordingly, to ensure the smooth functioning of the internal market, it is necessary to determine a common interpretation of the main elements of the criteria for designation of notified bodies set out in Directive 90/385/EEC and Directive 93/42/EEC.

The common interpretation of the criteria for designation provided by this Regulation does not suffice to assure their consistent application. The assessment methods in the Member States differ. They have a tendency to differ ever more due to the mentioned increased complexity of the work of conformity assessment bodies. Furthermore, many ad hoc questions arise in the day-to-day designation practice, in relation with new technologies and products. For these reasons, it is necessary to provide for procedural obligations which ensure a constant dialogue between Member States on their general practices and on ad hoc questions. This will bring to the surface discrepancies in the methods used to assess the conformity assessment bodies and in the interpretation of the criteria for their designation set out in Directive 90/385/EEC and Directive 93/42/EEC. Bringing the discrepancies to the surface will permit to develop a common interpretation of the assessment methods, especially with regard to new technologies and devices.

To ensure a common approach from the designating authorities and neutral conditions for competition those authorities should base their decisions on a common set of documents which lay the ground for the verification of the criteria for designation set out in Directive 90/385/EEC and Directive 93/42/EEC.

To facilitate, in a view of the increasingly complex work of conformity assessment bodies, a common application of the criteria established for their designation, those bodies should be assessed by teams of assessors representing the knowledge and experience of different Member States and of the Commission. To facilitate such assessments, certain essential documents should be accessible to those involved in these activities. Designating authorities from Member States other than the Member State where the conformity assessment body is established should have the possibility to review the documentation related to the assessment and to comment on intended designations if they so wish. The access to those documents is necessary in order to allow the identification of weaknesses of the applicant conformity assessment bodies as well as discrepancies in the Member States’ assessment methods and in their interpretation of the criteria for designation set out in Directive 90/385/EEC and Directive 93/42/EEC.

In order to ensure that the common interpretation of the criteria established applies similarly to scope extensions, which often...