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In particular, notified bodies shall have the necessary personnel and possess or have access to all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which they have been designated.
Such requirement presupposes at all times and for each conformity assessment procedure and each type of devices in relation to which they have been designated, that the notified body has permanent availability of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the relevant devices and the corresponding technologies. Such personnel shall be in sufficient numbers to ensure that the notified body in question can perform the conformity assessment tasks, including the assessment of the medical functionality, clinical evaluations and the performance and safety of devices, for which it has been designated, having regard to the requirements of this Regulation, in particular, those set out in Annex I.
A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is designated. The notified body shall have sufficient internal competence to critically evaluate assessments conducted by external expertise. Tasks which a notified body is precluded from subcontracting are set out in Section 4.1.
Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices shall have appropriate knowledge to set up and operate a system for the selection of assessment and verification staff, for verification of their competence, for authorisation and allocation of their tasks, for organisation of their initial and ongoing training and for the assignment of their duties and the monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification operations are competent to fulfil the tasks required of them.
The notified body shall identify at least one individual within its top-level management as having overall responsibility for all conformity assessment activities in relation to devices.
Specific qualification criteria shall be defined at least for the assessment of:
the pre-clinical evaluation,
clinical evaluation,
tissues and cells of human and animal origin,
functional safety,
software,
packaging,
devices that incorporate as an integral part a medicinal product,
devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body and
the different types of sterilisation processes.
Union devices legislation and relevant guidance documents;
the conformity assessment procedures provided for in this Regulation;
a broad base of knowledge of device technologies and the design and manufacture of devices;
the notified body's quality management system, related procedures and the required qualification criteria;
training relevant to personnel involved in conformity assessment activities in relation to devices;
adequate experience in conformity assessments under this Regulation or previously applicable law within a notified body.
identify when specialist input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts;
appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and harmonised standards and ensure that the external clinical experts are fully aware of the context and implications of their assessment and the advice they provide;
be able to review and scientifically challenge the clinical data contained within the clinical evaluation, and any associated clinical investigations, and appropriately guide external clinical experts in the assessment of the clinical evaluation presented by the manufacturer;
be able to scientifically evaluate and, if necessary, challenge the clinical evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's clinical evaluation;
be able to ascertain the comparability and consistency of the assessments of clinical evaluations conducted by clinical experts;
be able to make an assessment of the manufacturer's clinical evaluation and a clinical judgement of the opinion provided by any external expert and make a recommendation to the notified body's decision maker; and
be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy, engineering or other relevant sciences;
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
knowledge of device legislation, including the general safety and performance requirements set out in Annex I;
appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
appropriate knowledge and experience of risk management and related device standards and guidance documents;
appropriate knowledge and experience of clinical evaluation;
appropriate knowledge of the devices which they are assessing;
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments;
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management;
appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents;
appropriate knowledge and experience of risk management and related device standards and guidance documents;
appropriate knowledge of quality management systems and related standards and guidance documents;
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those audits;
training in auditing techniques enabling them to challenge quality management systems;
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
devices legislation and relevant guidance documents;
the device conformity assessments relevant to this Regulation;
the types of qualifications, experience and expertise relevant to device conformity assessment;
a broad base of knowledge of device technologies, including sufficient experience of conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
the notified body's quality management system, related procedures and the required qualifications for personnel involved;
the ability to draw up records and reports demonstrating that the conformity assessment activities have been appropriately carried out.
a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment activities; and
records attesting to the required knowledge and experience for the conformity assessment activity for which they are authorised. The records shall contain a rationale for defining the scope of the responsibilities for each of the assessment personnel and records of the conformity assessment activities carried out by each of them.
The subcontracting of the auditing of quality management systems or of product related reviews as a whole shall not be permitted; nevertheless parts of those activities may be conducted by subcontractors and external auditors and experts working on behalf of the notified body. The notified body in question shall retain full responsibility for being able to produce appropriate evidence of the competence of subcontractors and experts to fulfil their specific tasks, for making a decision based on a subcontractor's assessment and for the work conducted by subcontractors and experts on its behalf.
The following activities may not be subcontracted by notified bodies:
review of the qualifications and monitoring of the performance of external experts;
auditing and certification activities where the subcontracting in question is to auditing or certification organisations;
allocation of work to external experts for specific conformity assessment activities; and
final review and decision making functions.
the subcontractor meets the relevant requirements of this Annex;
subcontractors and external experts do not further subcontract work to organisations or personnel; and
the natural or legal person that applied for conformity assessment has been informed of the requirements referred to in the first and second indent.
Any subcontracting or consultation of external personnel shall be properly documented, shall not involve any intermediaries and shall be subject to a written agreement covering, among other things, confidentiality and conflicts of interest. The notified body in question shall take full responsibility for the tasks performed by subcontractors.
are aware of Union and national law in force on devices, relevant harmonised standards, CS, guidance documents and the results of the coordination activities referred to in Section 1.6; and
take part in the internal exchange of experience and the continuous training and education programme referred to in Section 3.1.2.