Notified Body Designation
What competencies are evaluated by the Competent Authority to desaignate a Notified Body?
Council Directive 90/385/EEC
(5 September 2007)
MINIMUM CRITERIA TO BE MET WHEN
DESIGNATING INSPECTION BODIES TO BE NOTIFIED
1. The body, its director and the staff responsible for carrying out the evaluation and verification operations shall not be the designer, manufacturer, supplier or installer of devices which they control, nor the authorized representative of any of those parties. They may not become directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.
2. The body and its staff must carry out the evaluation and verification operations with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of the inspection, especially from persons or groups of persons with an interest in the results of verifications.
3. The body must be able to carry out all the tasks in one of Annexes 2 to 5 assigned to such a body and for which it has been notified, whether those tasks are carried out by the body itself or under its responsibility. In particular, it must have at its disposal the necessary staff and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with evaluation and verification; it must also have access to the equipment necessary for the verifications required.
4. The staff responsible for control operations must have:
- sound vocational training covering all the evaluation and verification operations for which the body has been designated,
- satisfactory knowledge of the requirements of the controls they carry out and adequate experience of such operations,
- the ability required to draw up the certificates, records and reports to demonstrate that the controls have been carried out.
5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of controls carried out, nor on the results of such controls.
6. The body must take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for controls.
7. The staff of the body are bound to observe professional secrecy with regard to all information gained in carrying out their tasks (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under this Directive or any provision of national law giving effect to it.
CRITERIA FOR THE DESIGNATION AND OPERATION OF NOTIFIED BODIES
1. General requirements
a) Resources: The Notified Body shall provide the resources for conformity assessment of medical devices as specified in the directives in a competent, transparent, neutral, independent and impartial manner.
A body may be designated to offer the services set out in one or more of the relevant annexes of the directives.
The applicant must be capable of taking full responsibility for all tasks required of a Notified Body in relation to the (or those) annexe(s) of the directives and the medical devices for which it is being designated.
Once designated, the Notified Body shall, without delay, inform the Competent Authority responsible for designation of any change regarding availability of resources, including sub-contractors, and compliance with designation conditions which may have an impact on the maintenance of the designation and of the assignment of tasks.
b) The Notified Body shall be a legally defined entity and shall make available to the Competent Authority responsible for designation on request:
i. documentation clearly identifying its legal status; ii. documentation which clearly shows both the authority and the responsibility of individuals within, and the reporting structure within the Notified Body; iii. documentation about its financial situation.
c) If the Notified Body is a legal entity, which is part of a larger organisation, the links and relationship between the Notified Body and the larger organisation shall be clearly documented.
a) The Notified Body and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of medical devices, nor the authorized representative of any of those parties engaged in these activities. The assessment and verification staff including subcontractors shall be impartial and free from engagements and influences, which could affect their objectivity, and in particular shall not be:
- involved in the design, construction, marketing, installation, servicing or supply of the devices within the scope of the audit;
- involved in the design, construction, implementation or maintenance of the quality system being audited; nor represent the parties engaged in these activities.
- NB The term ‘user’ in this context is not meant to exclude the use of individual clinicians as assessment and verification staff.
b) Links with manufacturers: The directors, executives and personnel (whether directly employed or subcontracted) responsible for carrying out the evaluation and verification activities shall be independent of both the manufacturers for whom the Notified Body conducts assessments and the commercial competitors of those manufacturers, during their employment by the Notified Body. They shall not have been involved in the design, construction, marketing or maintenance of the devices.
c) Consultancy: Notified Body personnel (whether directly employed or subcontracted) shall not offer or provide (or have offered or provided) consultancy or advice to the manufacturer, the authorised representative, a supplier or their commercial competitor as regards the design, construction, marketing or maintenance of the products under assessment.
a) The Notified Body shall guarantee the impartiality of all assessment and verification personnel and ensure that the remuneration of personnel shall not depend on the number of inspections and verifications that they carry out, nor on the results of their activities.
b) The Notified Body shall ensure by implementation of documented procedures that personnel are free from pressures and inducements, particularly financial, which might influence their judgement during any assessment or inspection that they perform.
a) The Notified Body shall employ within the organisation the necessary administrative, technical, medical and scientific personnel, which possess satisfactory knowledge and experience relating to the medical devices, technologies and conformity assessment procedures assigned to them. Knowledge and experience related to the scope of assignment of tasks shall include in particular:
- regulatory requirements and enforcement policies;
- European and international standardization activities;
- methodology of risk analysis and risk management regarding relevant medical technology, production methods and the applicable verification procedures; the personnel shall be capable of assessing the medical function and performance of devices and the processes to determine compliance with essential requirements especially for those cases where no specific standards are available;
- clinical evaluation, conduct of clinical investigations and normal conditions of use of relevant medical devices.
b) The Notified Body shall have documented the competence and training requirements for assessment and verification staff. Records shall be available to demonstrate that personnel have the appropriate experience and have received appropriate training relevant to the Notified Body’s scope.
c) Notified Bodies shall participate in co-ordination activities at European and/or national level in order to attain maximum coherence in performing conformity assessment.
d) Notified Bodies carrying out assessments under annexes 2 and 5 of the active implantable medical devices directive, and annexes II, V and VI of the medical devices directive shall require that such quality system audits are conducted by a team that includes at least one member who is experienced in the evaluation of the technologies used by the manufacturer.