Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title

3.2. Qualification criteria in relation to personnel U.K.

3.2.1. The notified body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities, including as regards knowledge, experience and other competence required, and the required initial and ongoing training. The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review, decision-making, and batch release, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics and performance evaluation, covered by the scope of designation. U.K.

3.2.2. The qualification criteria referred to in Section 3.2.1 shall refer to the scope of the notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 38(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description. U.K.

Specific qualification criteria shall be defined at least for the assessment of:

• biological safety,

• performance evaluation,

• devices for self and near patient testing,

• companion diagnostics,

• functional safety,

• software,

• packaging, and

• the different types of sterilisation processes.

3.2.3. The personnel responsible for establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities shall be employed by the notified body itself and shall not be external experts or subcontracted. They shall have proven knowledge and experience in all of the following: U.K.

• 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.

3.2.4. The notified body shall have permanent availability of personnel with relevant clinical expertise and where possible such personnel shall be employed by the notified body itself. Such personnel shall be integrated throughout the notified body's assessment and decision-making process in order to: U.K.

• identify when specialist input is required for the assessment of the performance 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 performance evaluation, and any associated performance study, and appropriately guide external clinical experts in the assessment of the performance evaluation presented by the manufacturer;

• be able to scientifically evaluate and, if necessary, challenge the performance evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's performance evaluation;

• be able to ascertain the comparability and consistency of the assessments of performance evaluation conducted by clinical experts;

• be able to make an assessment of the manufacturer's performance 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.

3.2.5. The personnel responsible for carrying out product-related reviews, (product reviewers), such as technical documentation reviews or type examination, including aspects such as performance evaluation, biological safety, sterilisation and software validation, shall have all the following proven qualifications: U.K.

• successful completion of a university or a technical college degree or an 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 design, manufacture, testing or use of devices 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 performance 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.

3.2.6. The personnel responsible for carrying out audits of the manufacturer's quality management system (site auditors) shall have all of the following proven qualifications: U.K.

• 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 l devices 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.

3.2.7. The personnel with overall responsibility for final reviews and decision-making on certification shall be employed by the notified body itself and shall not be external experts or be subcontracted. Those personnel, as a group, shall have proven knowledge and comprehensive experience of all of the following: U.K.

• devices legislation and relevant guidance documents;

• 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 the conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;

• the notified body's quality 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.