Notified Body Designation?

Notified Body Designation
What competencies are evaluated by the Competent Authority to desaignate a Notified Body?

COUNCIL DIRECTIVE 93/42/EEC
ANNEX XI
CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES

1.     The notified body, its Director and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative of any of these persons. They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.

2.         The notified body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications.

Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of the Directive and, in particular, of this Annex. The notified body shall keep at the disposal of the national authorities the relevant documents assessing the subcontractor’s qualifications and the work carried out by the subcontractor under this Directive.

3.     The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes II to VI and for which it has been notified, whether these tasks are carried out by the body itself or on its responsibility. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification. This presupposes the availability of sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Directive and, in particular, those set out in Annex I. It must also have access to the equipment necessary for the verifications required.

4.         The notified body must have:

• sound vocational training covering all the assessment and verification operations for which the body has been designated,
• satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections,
• the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.

5.     The impartiality of the notified body must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.

6.     The body must take out civil liability insurance, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.

7.     The staff of the notified body are bound to observe professional secrecy with regard to all information gained in the course of their duties (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) pursuant to this Directive or any provision of national law putting it into effect.

MEDDEV 2.10-2 Rev. 1:  Designation and Monitoring of Notified Bodies within the Framework of EC Directives on Medical Devices

(April 2001)

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.

Independence requirements
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.

Impartiality requirements
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.

Competence requirements

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.

Internal procedures and facilities – requirements
a) The Notified Body shall have appropriate structures and procedures to ensure that conduct of conformity assessment and issuing of certificates is subject to a review process. Relevant procedures shall in particular address obligations and responsibilities in relation to suspension and withdrawal of certificates, imposition of corrective measures to manufacturers and reporting to Competent Authority.

b) The Notified Body shall have available the appropriate facilities to enable it to carry out the assessment and verification activities for which it has been notified.

Confidentiality requirements
a) The Notified Body shall have made adequate arrangements to ensure confidentiality of the information obtained in the course of carrying out its tasks under the regulations.

These arrangements shall ensure that no details, records, results or information of any kind are disclosed to any other party except the relevant Competent Authorities and the manufacturer.

Liability insurance – requirements
a) Provisions for misadventure : the Notified Body shall take out appropriate liability insurance to provide for claims and litigation in the event of misadventure, unless liability is assured under the domestic legislation of the Member State responsible for the designation of the Notified Body.

Subcontracts – requirements
a) Contract requirements: where specific tasks relating to conformity assessment are carried out by subcontractors, the Notified Body shall ensure that these subcontractors conform to all the requirements of the regulations that would apply, had the task been performed by its own personnel. The manufacturer’s approval shall be obtained before activities are subcontracted.

b) Limitation to scope: the Notified Body shall not subcontract the overall responsibility for reviewing the outcome of assessment and verification activities, which are the essential tasks for which it was notified. Subcontractors shall fulfil only an objective role, that is, one, which is restricted to factual reporting and/or supported recommendations, on the basis of which the Notified Body shall make assessments and judgements in relation to the requirements of the regulations.

c) Documented agreement: a documented agreement shall be drawn up between the Notified Body and the subcontractor reflecting these requirements, including agreement shall also prohibit subcontractors from further subcontracting their duties.

d) Subcontractor’s documentation: the Notified Body shall ensure that the subcontracted activities are carried out according to detailed documented procedures which are the same as, or judged by the Notified Body to be equivalent to, those followed by the Notified Body itself in the context of conformity assessment.

e) Competence: the competence of subcontractors may be assumed where they are accredited by the Competent Authority or the authorised national accreditation body according to Annex XI of 93/42/EEC or Annex 8 of 90/385/EEC and EN 45001 for the scope under consideration.

f) Register: the Notified Body shall inform the Competent Authority of its intention to subcontract duties in relation to the scope for which it was appointed. The Notified Body shall keep an up to date register of all its subcontractors, which shall be provided to the Competent Authority responsible for the designation on request. The Notified Body shall maintain documentary evidence that the subcontractor has the necessary technical competence and facilities to carry out the subcontracted activities.

Notified Body’s quality system – requirements
a) The Notified Body shall establish and maintain up to date documented procedures and records which, together, demonstrate its compliance with the regulations. As appropriate, this documentation shall include the following.

i. a description of the legal status of the Notified Body, including the links and relationship with parent organisation, if relevant,

ii. documentation showing the responsibilities and reporting structure of the Notified Body,

iii. a rationale for defining the scope of the responsibilities for each of the assessment personnel,

iv. the names of assessment personnel, both internal and subcontracted, their assessment responsibilities, and records of their relevant training and experience;

v. procedures for the identification review and resolution of all cases where conflict of interests is suspected or proven;

vi. a description of the application process by which manufacturers can obtain third party approval by the Notified Body. The document shall specify which languages are acceptable for submissions and correspondence from manufacturers relating to their demonstration of compliance with the requirements of the directives,

vii. procedures to review applications in respect to the manufacturer’s classifications of his medical devices,

viii. procedures to review the completeness of application against the details provided in the annex under which approval has been sought,

ix. procedures to evaluate and verify manufacturers’ compliance with their chosen annexes,

x. procedures detailing the rationale for fixing time limits for completion of evaluation and verification activities,

xi. procedures for the demarcation between other Directives such as 65/65/EEC,

xii. procedures for the assessment of clinical data: if applicable, where the results have been derived from clinical investigations the Notified Body shall ensure that the conclusions drawn by the manufacturer are valid in the light of the plan of clinical investigation submitted to the Competent Authority.

xiii. procedures to take account of information on medical devices subject to pre-existing national law, regulations or administrative provisions,

xiv. records to demonstrate the conclusions of the assessment including a reasoned evaluation of the manufacturer’s compliance with the requirements of the relevant directive. For quality assessments, records should be available which provide a discernible audit trail (e.g. procedures, processes, records, products etc that were assessed),

xv. procedures for the consideration of appeals against decisions made by the Notified Body regarding:

* the interpretation of classification rules, including referral to the Competent Authority where necessary;
* a manufacturer’s compliance with the requirements of the directives.

xvi. procedures relating to the issue, expiration, withdrawal and suspension of certificates, including action to be taken in the event of the Notified Body learning that a CE mark has been wrongly affixed to a device or to a product outside the scope of medical devices directives. These procedures shall include a requirement to inform the Competent Authority forthwith of any such action taken,

xvii. details of obligations regarding communications with other organisations, including Competent Authorities, the Commission and other Notified Bodies (ie about all certificates suspended or withdrawn and on request about certificates issued or refused and any additional relevant information), and the means adopted for these communications. The documentation shall also include records of all communications with the Commission and action taken as a result of such communications. (e.g. in respect to safeguard issues) These records shall be made available to the Competent Authority on request,

xviii. procedures for assessing and monitoring the competence of subcontractors, if used,

xix. details of record keeping facilities including means to ensure security and confidentiality,

xx. details about liability insurance,

xxi. documentation about its financial situation, including accounts,

xxii. details about fees and financial conditions for the conduct of conformity assessment,

xxiii procedure for the provision of information in relation to the EUDAMED database.

b) Control: a system shall be maintained to control all quality system documentation and to ensure that current issues of procedures are available at all relevant locations

c) The Notified Body shall ensure that the defined quality system procedures are effectively implemented