Text proposed by the Commission Amendment

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 (knowledge, experience and other competence required) and the required training (initial and ongoing training). The qualification criteria shall address the various functions within the conformity assessment process (e.g. auditing, product evaluation/testing, design dossier/file review, decision-making) as well as the devices, technologies and areas covered by the scope of designation. 3.2.1. The MDCG shall establish and document the principles of high level competence and qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing training). The qualification criteria shall address the various functions within the conformity assessment process (e.g. auditing, product evaluation/testing, design dossier/file review, decision-making) as well as the devices, technologies and areas covered by the scope of designation.

3.2.2. The qualification criteria 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 31, providing sufficient level of detail for the required qualification within the subdivisions of the scope description. 3.2.2. The qualification criteria 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 31, providing sufficient level of detail for the required qualification within the subdivisions of the scope description.

Specific qualification criteria shall be defined for the assessment of biocompatibility aspects, clinical evaluation and the different types of sterilisation processes. Specific qualification criteria shall be defined for the assessment of biocompatibility aspects, safety, clinical evaluation and the different types of sterilisation processes.

3.2.3. The personnel responsible for authorising other personnel to perform specific conformity assessment activities and the personnel with overall responsibility for the final review and decision-making on certification shall be employed by the notified body itself and shall not be subcontracted. This personnel altogether shall have proven knowledge and experience in the following: 3.2.3. The personnel responsible for authorising other personnel to perform specific conformity assessment activities and the personnel with overall responsibility for the final review and decision-making on certification shall be employed by the notified body itself and shall not be subcontracted. This personnel altogether shall have proven knowledge and experience in the following:

— Union in vitro diagnostic medical devices legislation and relevant guidance documents; — Union in vitro diagnostic medical devices legislation and relevant guidance documents;

— the conformity assessment procedures in accordance with this Regulation; — the conformity assessment procedures in accordance with this Regulation;

— a broad base of in vitro diagnostic medical device technologies, the in vitro diagnostic medical device industry and the design and manufacture of in vitro diagnostic medical devices; — a broad base of in vitro diagnostic medical device technologies, the in vitro diagnostic medical device industry and the design and manufacture of in vitro diagnostic medical devices;

— the notified body’s quality management system and related procedures; — the notified body’s quality management system and related procedures;

— the types of qualifications (knowledge, experience and other competence) required for carrying out conformity assessments in relation to in vitro diagnostic medical devices as well as the relevant qualification criteria; — the types of qualifications (knowledge, experience and other competence) required for carrying out conformity assessments in relation to in vitro diagnostic medical devices as well as the relevant qualification criteria;

— training relevant to personnel involved in conformity assessment activities in relation to in vitro diagnostic medical devices; — training relevant to personnel involved in conformity assessment activities in relation to in vitro diagnostic medical devices;

— the ability to draw up certificates, records and reports demonstrating that the conformity assessments have been appropriately carried out. — the ability to draw up certificates, records and reports demonstrating that the conformity assessments have been appropriately carried out.

— at least three years' appropriate experience in the field of conformity assessments within a notified body,

— adequate seniority/experience in conformity assessments under this Regulation or previously applicable law during a period of at least three years within a notified body. The notified body staff involved in certification decisions shall not have been involved in the conformity assessment on which a certification decision needs to be taken.

3.2.4. Notified bodies shall have available personnel with clinical expertise. This personnel shall be integrated in the notified body's decision-making process in a steady way in order to: 3.2.4. Clinical experts: n otified bodies shall have available personnel with expertise in clinical investigation design, medical statistics, clinical patient management, Good Clinical Practice in the field of clinical investigations. Permanent ‘in house’ staff shall be used. However, in accordance with Article 28, notified bodies may hire external experts on an ad hoc and temporary basis provided they can make publicly available the list of those experts, as well as the specific tasks for which they are responsible. This personnel shall be integrated in the notified body's decision-making process in a steady way in order to:

— identify when specialist input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts; — identify when specialist input is required for the assessment of the clinical investigation plans and the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts;

— appropriately train external clinical experts in the relevant requirements of this Regulation, delegated and/or implementing acts, harmonised standards, CTS and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided; — appropriately train external clinical experts in the relevant requirements of this Regulation, delegated and/or implementing acts, harmonised standards, CTS and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided;

— be able to discuss the clinical data contained within the manufacturer's clinical evaluation with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation; — be able to discuss the rationale of the planned study design, the clinical investigation plans and the selection of the control intervention with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation;

— be able to scientifically challenge the clinical data presented, and the results of the external clinical experts' assessment of the manufacturer's clinical evaluation; — be able to scientifically challenge the clinical investigation plans and the clinical data 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 clinical assessments conducted by clinical experts; — be able to ascertain the comparability and consistency of the clinical assessments conducted by clinical experts;

— be able to make an objective clinical judgement about the assessment of the manufacturer's clinical evaluation and make a recommendation to the notified body's decision maker. — be able to make an objective clinical judgement about the assessment of the manufacturer's clinical evaluation and make a recommendation to the notified body's decision maker.

— ensure independence and objectivity and disclose potential conflicts of interest.

3.2.5. The personnel responsible for carrying out product related review (e.g. design dossier review, technical documentation review or type examination including aspects such as clinical evaluation, sterilisation, software validation) shall have the following proven qualification: 3.2.5. Product assessors: t he personnel responsible for carrying out product related reviews (e.g. design dossier review, technical documentation review or type examination including aspects such as clinical evaluation, sterilisation, software validation) shall have specialist qualifications which should include :

— successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, natural science or engineering; — successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, natural science or engineering;

— four years professional experience in the field of healthcare products or related sectors (e.g. industry, audit, healthcare, research experience) whilst two years of this experience 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; — four years professional experience in the field of healthcare products or related sectors (e.g. industry, audit, healthcare, research experience) whilst two years of this experience shall be in the design, manufacture, testing or use of the device (as defined within a generic device group) or technology to be assessed or related to the scientific aspects to be assessed;

— appropriate knowledge of the general safety and performance requirements laid down in Annex I as well as related delegated and/or implementing acts, harmonised standards, CTS and guidance documents; — appropriate knowledge of the general safety and performance requirements laid down in Annex I as well as related delegated and/or implementing acts, harmonised standards, CTS and guidance documents;

— qualification based on technical or scientific fields (e.g. sterilization, biocompatibility, animal tissue, human tissue, software, functional safety, clinical evaluation, electrical safety, packaging);

— appropriate knowledge and experience of risk management and related in vitro diagnostic medical device standards and guidance documents; — appropriate knowledge and experience of risk management and related in vitro diagnostic medical device standards and guidance documents;

— appropriate knowledge and experience of clinical evaluation;

— appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes VIII to X, in particular of those aspects for which they are authorised, and adequate authority to carry out those assessments — appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes VIII to X, in particular of those aspects for which they are authorised, and adequate authority to carry out those assessments

3.2.6. The personnel responsible for carrying out audits of the manufacturer's quality management system shall have the following proven qualification: 3.2.6. Auditor: The personnel responsible for carrying out audits of the manufacturer's quality assurance system shall have specialist qualifications, which should include :

— successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, natural science or engineering — successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, natural science or engineering

— four years professional experience in the field of healthcare products or related sectors (e.g. industry, audit, healthcare, research experience) whilst two years of this experience shall be in the area of quality management — four years professional experience in the field of healthcare products or related sectors (e.g. industry, audit, healthcare, research experience) whilst two years of this experience shall be in the area of quality management

— appropriate knowledge of technologies such as those defined by IAF/EAC coding or equivalent;

— appropriate knowledge of the in vitro diagnostic medical devices legislation as well as related delegated and/or implementing acts, harmonised standards, CTS and guidance documents; — appropriate knowledge of the in vitro diagnostic medical devices legislation as well as related delegated and/or implementing acts, harmonised standards, CTS and guidance documents;

— appropriate knowledge and experience of risk management and related in vitro diagnostic medical device standards and guidance documents; — appropriate knowledge and experience of risk management and related in vitro diagnostic medical device standards and guidance documents;

— appropriate knowledge of quality management systems and related 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 VIII to X, in particular of those aspects for which they are authorised, and adequate authority to carry out the audits; — appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes VIII to X, in particular of those aspects for which they are authorised, and adequate authority to carry out the audits;