Conformity assessment procedure for in vitro diagnostic devices

In Vitro Diagnostic Medical Devices (IVDD)

The technical requirements for in vitro diagnostic medical devices are set forth in Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices, as amended. This Directive has been transposed into Czech law as Government Regulation No. 56/2015 Coll., on technical requirements for in vitro diagnostic medical devices. An in vitro diagnostic medical device must comply with the requirements set forth in Annex 1 of Government Regulation No. 56/2015 Coll., taking into account its intended use. The essential requirements are considered met if the IVD complies with the relevant harmonized standards. Common technical specifications for IVDs are considered harmonized standards under Government Regulation No. 56/2015 Coll. – see also European Commission Decision 2002/364/EC (as amended) on common technical specifications for in vitro diagnostic medical devices. An overview of all harmonized standards for IVDs is available on the European Commission’s website. Annex No. 1 to Government Regulation No. 56/2015 Coll. contains general requirements, as well as requirements for the design and manufacture of IVDs. Compliance with the essential requirements is demonstrated by the manufacturer or its authorized representative to the notified body in the form of a checklist, which is a prerequisite for conformity assessment. IVDs are classified according to Annex No. 2 of Government Regulation No. 56/2015 Coll. into Lists “A” and “B.” Furthermore, IVDs are distinguished for the purposes of self-testing and for the assessment of functional capability.

IVDs may be placed on the market if their conformity has been assessed in accordance with Government Regulation No. 56/2015 Coll., they meet the essential requirements and other provisions applicable to them under Government Regulation No. 56/2015 Coll., a declaration of conformity has been issued for them in accordance with this regulation, and they have been affixed with the CE marking (except for IVDs for performance evaluation).

The Ministry of Industry and Trade of the Czech Republic (MPO ČR) states on its website that, effective July 22, 2016, for in vitro diagnostic medical devices that are electrical or electronic equipment pursuant to Government Regulation No. 481/2012 Coll., on the restriction of the use of certain hazardous substances in electrical and electronic equipment, restrictions on the content of hazardous substances (lead, cadmium, mercury, hexavalent chromium, PBB—polybrominated biphenyls—and PBDE—polybrominated diphenyl ethers) in concentrations exceeding the limits.

Conformity Assessment

Conformity assessment of IVDs other than those listed in Annex No. 2 to Government Regulation No. 56/2015 Coll. and those intended for performance verification shall be carried out in accordance with Annex No. 3 to Government Regulation No. 56/2015 Coll. Before issuing a written EC Declaration of Conformity, the manufacturer of a self-test IVD must meet the additional requirements specified in Section 7 of Annex 3 to Government Regulation No. 56/2015 Coll. – The manufacturer submits an application for design review to a notified body; if the design reviewed by the notified body complies with the relevant provisions of Government Regulation No. 56/2015 Coll., the applicant receives a design review certificate.

Conformity assessment of IVDs for self-testing is carried out:

in accordance with Annex No. 4 (full quality assurance system, quality system, and IVD design review) of Government Regulation No. 56/2015 Coll. or
in accordance with Annex No. 5 (type examination) together with the procedure set forth in Annex No. 7 (production quality assurance) of Government Regulation No. 56/2015 Coll.,

but may also proceed in accordance with:

Annex No. 4 (full quality assurance system, quality system, and IVD design review) of Government Regulation No. 56/2015 Coll. or
Annex No. 5 (type examination) together with the procedure set forth in Annex No. 6 or Annex No. 7 (production quality assurance) of Government Regulation No. 56/2015 Coll.
When assessing conformity in accordance with Annex 6 of Government Regulation No. 56/2015 Coll., the IVD manufacturer ensures and declares that its IVDs have been verified by a notified body and correspond to the type described in the EC type-examination certificate and comply with the provisions of Government Regulation No. 56/2015 Coll.

The conformity assessment of IVDs listed in List A of Annex No. 2 to Government Regulation No. 56/2015 Coll. and which are not intended for performance evaluation shall be carried out in accordance with:

Annex 4 (full quality assurance system, quality system, and IVD design review) of Government Regulation No. 56/2015 Coll. or

Annex No. 5 (type examination) together with the procedure under Annex No. 7 (production quality assurance) of Government Regulation No. 56/2015 Coll.

An IVD manufacturer listed in List A of Annex No. 2 to Government Regulation No. 56/2015 Coll. shall submit an application to a notified body for design examination and, for the purpose of verification, shall provide the notified body with samples of the manufactured IVDs and the relevant records of the tests performed. The IVD manufacturer shall establish and maintain a quality system approved for the design, manufacture, and final inspection of the relevant IVDs in accordance with Annex 4 to Government Regulation No. 56/2015 Coll. and shall be subject to supervision by the notified body. The IVD manufacturer shall issue a declaration of conformity, thereby guaranteeing and declaring that the relevant IVDs comply with the provisions of Government Regulation No. 56/2015 Coll. that apply to them.

Conformity assessment of IVDs listed in List B of Annex No. 2 to Government Regulation No. 56/2015 Coll. and which are not intended for performance evaluation shall be carried out in accordance with:

Annex 4 (full quality assurance system, quality system, and IVD design review) of Government Regulation No. 56/2015 Coll. or
Annex 5 (type examination) together with the procedure under Annex 6 (EC verification) or Annex 7 (production quality assurance) of Government Regulation No. 56/2015 Coll.

The manufacturer must retain the EC type-examination certificate and issue a declaration of conformity, thereby guaranteeing and declaring that the relevant IVD conforms to the type described in the EC type-examination certificate and complies with the provisions of Government Regulation No. 56/2015 Coll. that apply to it.

The conformity assessment of IVDs for verification of performance is carried out in accordance with Annex No. 8 (declarations and procedures concerning IVDs for performance evaluation) of Government Regulation No. 56/2015 Coll. A declaration means a notification of the performance evaluation pursuant to the provisions of Section 23 of Act No. 268/2014 Coll.

For all IVDs not listed in Annex No. 2 of Government Regulation No. 56/2015 Coll. and which are intended for performance evaluation, the manufacturer shall prepare a written declaration of conformity prior to placing them on the market.

The IVD manufacturer declares and guarantees that the relevant IVDs comply with the provisions of Government Regulation No. 56/2015 Coll. that apply to them.

For inspection purposes, the manufacturer is required to keep the declaration of conformity, the technical documentation specified in Annexes 3 through 8 of Government Regulation No. 56/2015 Coll., as well as the EC design examination reports, EC type-examination certificates, or decisions issued by notified bodies.

CE Marking

The CE marking on an IVD must be accompanied by the identification number of the notified body involved in the procedures set out in Annexes 3, 4, No. 6, and No. 7 to Government Regulation No. 56/2015 Coll. The CE marking indicates conformity only with those legal regulations or their provisions that the manufacturer has applied. The documentation, warnings, or instructions accompanying the relevant IVDs must include a list of the applicable legal regulations and EU directives whose requirements have been incorporated into those legal regulations. The CE marking shall be affixed visibly, legibly, and indelibly to the IVD, or to the packaging and instructions for use, as appropriate.