Staff
1. The EU reference laboratories shall document and justify the knowledge and experience requirements for staff, including the director, the scientific and the technical staff, needed to fulfil the EU reference laboratory tasks in the field of specific devices, categories or groups of devices, or specific hazards related to a category or group of devices for which the EU reference laboratories are designated (‘scope of designation’).
2. The EU reference laboratories shall have staff that fulfils the requirements referred to in paragraph 1 and document how those requirements are fulfilled.
3. The EU reference laboratories shall have a sufficient number of the staff referred to in paragraph 2 in relation to the volume of the tasks that the EU reference laboratories are to carry out in their scope of designation.
4. The EU reference laboratories shall put in place a continuous training and education programme for their staff.
Equipment and reference materials
The EU reference laboratories shall keep up-to-date documentation containing:
(a)
an explanation of which equipment, including specimens and control materials, and reference materials are necessary to carry out the tasks assigned to them within their scopes of designation;
(b)
evidence that they possess the equipment and a sufficient quantity of the reference materials referred to in point (a);
(c)
a plan for the procurement of the specimens, control materials and reference materials referred to in point (a).
The EU reference laboratories shall make the documentation referred to in the first subparagraph available to the Commission, upon its request.
International standards and best practices
The EU reference laboratories shall keep up-to-date documentation containing:
(a)
a list of international standards and best practices, including common specifications, that apply to the tasks assigned to them within their scopes of designation, and a justification of the relevance of such standards and practices where that relevance is not obvious;
(b)
evidence that they have integrated the international standards and best practices referred to in point (a) into the operating procedures for the relevant tasks.
The EU reference laboratories shall make the documentation referred to in the first subparagraph available to the Commission, upon its request.
Administrative organisation and structure
1. The EU reference laboratories shall identify at least one person within its management as having overall responsibility for the performance of the tasks set out in Article 100(2) of Regulation (EU) 2017/746.
2. The EU reference laboratories shall have sufficient administrative staff to provide the necessary administrative support for performance of the tasks set out in Article 100(2) of Regulation (EU) 2017/746, in relation to the volume of those tasks.
3. The EU reference laboratories shall establish and keep up-to-date documentation containing the following:
(a)
evidence of their status as a legal entity;
(b)
where they are part of a larger organisation, a description of the activities of that organisation, its organisational structure and governance;
(c)
where they are, directly or indirectly, controlled by other entities, the identity of such entities and their controlling position;
(d)
a description of their internal organisational structure with clearly allocated responsibilities and reporting lines;
(e)
a description of their operating procedures, including management and performance of tasks, management of staff, a staff substitution plan, as well as registration of documentation and correspondence with external entities;
(f)
a declaration that none of the situations for exclusion set out in Article 136 of Regulation (EU, Euratom) 2018/1046 apply to them;
(g)
evidence of their sources of funding and of economic viability without financial assistance from the Union;
(h)
detailed records of the calculation of the costs and the corresponding fees levied for each task they are requested to perform;
(i)
a yearly overview of the tasks performed.
The EU reference laboratories shall make the documentation referred to in the first subparagraph available to the Commission, upon its request.
Confidentiality
1. EU reference laboratories shall have a confidentiality policy that includes the following:
(a)
the type of information that shall be considered confidential;
(b)
rules for the appropriate secure handling, storage and processing of confidential information and measures to prevent undue disclosure;
(c)
rules for sharing of confidential and non-confidential information with staff, and the public;
(d)
rules for granting access to confidential information to a competent authority of a Member State upon its request in the context of market surveillance or vigilance activities by the competent authority;
(e)
rules for sharing confidential information, on the initiative of the EU reference laboratory, with a competent authority of a Member State and with the Commission where the EU reference laboratory has reason to believe that such sharing is in the interest of protection of public health.
2. EU reference laboratories shall put in place and document measures to ensure that the staff complies with the confidentiality policy referred to in paragraph 1.
Public interest, independence and conflicts of interest
1. Member States shall confirm that laboratories for which they have submitted an application for designation pursuant to Article 100(1) of Regulation (EU) 2017/746 will perform their tasks as EU reference laboratories in the public interest and in an independent manner within their proposed scopes of designation. That confirmation shall be included in the application.
2. EU reference laboratories shall have a policy to ensure that the members of their staff do not have financial or other interests in the in vitro medical device industry, which could affect their impartiality with regard to the performance of their tasks.
The policy referred to in the first subparagraph shall include steps to prevent, identify and resolve conflicts of interest and shall be made available to the Commission upon request.
3. An EU reference laboratory shall not be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices within its scope of designation, nor the authorised representative of any of those parties and shall not be involved in the design, manufacture or construction, marketing, installation, use or maintenance of the devices within its scope of designation.
An EU reference laboratory shall not act as a notified body for devices within its scope of designation.
Within its scope of designation, an EU reference laboratory shall not perform any tasks related to conformity assessment under Regulation (EU) 2017/746 on request by a notified body, other than the tasks referred to in Article 100(2) of Regulation (EU) 2017/746.
4. An EU reference laboratory shall not enter into collaboration with a device manufacturer or a notified body concerning a joint commercial exploitation if such collaboration falls within its scope of designation.
Outsourcing of testing and access to equipment from other laboratories
1. Where the volume of laboratory testing for a task assigned to an EU reference laboratory within its scope of designation so requires, it may outsource the testing or part of the testing to national reference laboratories and other laboratories established in a Member State (collectively referred to as ‘external laboratories’) or to another EU reference laboratory by way of a contract.
2. Where the volume, specific nature or novelty of a task assigned to an EU reference laboratory so requires, it may enter into a contract with an external laboratory or another EU reference laboratory to obtain access to specific additional equipment or materials that are needed for carrying out the task.
3. An EU reference laboratory may only conclude contracts referred to in paragraph 1 with external laboratories that fulfil the following conditions:
(a)
their competence for fulfilling the tasks covered by the contract, including staff and equipment, satisfies the requirements set by the EU reference laboratory;
(b)
they put in place and document the measures referred to in Article 5(2) to ensure that the staff involved in the performance of tasks covered by the contract complies with the confidentiality policy referred to in Article 5(1);
(c)
they confirm the absence of conflict of interest in accordance with the policy of the EU reference laboratory referred to in Article 6(2) as regards the activities covered by the contract.
4. The EU reference laboratories shall make the contracts referred to in the first subparagraph available to the Commission, upon its request.
5. The EU reference laboratory shall have the overall responsibility for the results of tests and the fulfilment of tasks within its scope of designation, regardless of any support received from external laboratories or other EU reference laboratories in accordance with this Article.
Accreditation
1. Member States or the Commission may presume that laboratories that are accredited in accordance with the harmonised standard EN ISO/IEC 17025, the reference of which has been published in the Official Journal of the European Union , by a national accreditation body, operating in accordance with Regulation (EC) No 765/2008, are in conformity with the requirements set out in the following provisions of this Regulation:
(a)
Article 1;
(b)
Article 2(1), point (b);
(c)
Article 4(1) and (2) and Article 4(3), points (a), (d) and (e);
(d)
Article 5(1), points (a) to (c) and Article 5(2);
(e)
Article 6(2);
(f)
Article 7(3), points (a) to (c).
2. The scope of the accreditation referred to in paragraph 1:
(a)
shall cover the methods of laboratory analysis or testing which are relevant to the scope of designation of the EU reference laboratory;
(b)
may comprise one or more methods of laboratory analysis or testing or groups of methods;
(c)
may be defined in a flexible manner, so as to allow the scope of the accreditation to include modified versions of the methods used by the laboratories when the accreditation was granted or new methods in addition to those methods, on the basis of the laboratories’ own validations and without a specific assessment prior to the use of those modified or new methods by the national accreditation bodies.
Verification of compliance with criteria
1. Before submitting an application for designation of a laboratory in accordance with Article 100(1) of Regulation (EU) 2017/746, the Member States shall verify that the laboratory complies with the criteria set out in Article 100(4) of that Regulation, as further specified in Articles 1 to 7 of this Regulation.
2. Before submitting an application to be designated in accordance with Article 100(1) of Regulation (EU) 2017/746, the Commission’s Joint Research Centre shall verify that it complies with the criteria set out in Article 100(4) of that Regulation, as further specified in Articles 1 to 7 of this Regulation.
3. The Member States or the Commission’s Joint Research Centre shall document the verification referred to in paragraphs 1 and 2, and its outcome, in the application.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
