Conformity assessment procedure for active implantable medical devices

Active implantable medical devices (AIMD)

: Government Regulation

No. 55/2015 Coll. was repealed on May 26, 2021, by Act No. 89/2021 Coll.

The technical requirements for AIMDs are set forth in Council Directive 90/385/EEC (text without the correction of Directive 2007/47/EC of December 3, 2016). This Directive has been transposed into Czech law as Government Regulation No. 55/2015 Coll., on technical requirements for active implantable medical devices.

Before being placed on the market

an active implantable medical device must comply with the provisions of Act No. 268/2014 Coll. on medical devices, the essential requirements listed in Annex 1 to Government Regulation No. 55/2015 Coll., and other requirements applicable to this device, taking into account its intended purpose. Annex 1 to Government Regulation No. 55/2015 Coll. contains general requirements, requirements for design and construction, and information to be provided by the manufacturer. If an AIMD intended for a specific purpose complies with the relevant provisions of harmonized European standards published in the Official Journal of the EU, then that AIMD also complies with the essential requirements. An overview of all harmonized standards for AIMDs is available on the European Commission’s website. For the purposes of this Regulation, references to harmonized standards also include references to monographs of the European Pharmacopoeia.

The AIMD manufacturer must maintain documentation on the quality system and provide the notified body with the results of analyses, calculations, tests, preclinical and clinical evaluations, a plan for post-market or post-commissioning clinical follow-up to prevent the occurrence of adverse events, and the results of post-market clinical follow-up, reports on inspections, tests, calibration, calibration, and the qualification of relevant personnel. An active implantable medical device that is, for example, also a machine under Government Regulation No. 176/2008 Coll. must comply with the essential health and safety requirements set forth in that regulation to the extent that those essential requirements are stricter than the essential requirements set forth in Annex No. 1 to Government Regulation No. 55/2015 Coll. Practical support for a uniform interpretation of Directive 90/385/EEC (text without the correction of Directive 2007/47/EC of December 3, 2016) for AIMD manufacturers is also provided by the following documents:

MEDDEV 2.1/1 Definitions of "medical devices", "accessory" and "manufacturer" (1994),
MEDDEV 2.1/2 Rev. 2 Field of application of Directive "Active Implantable Medical Devices" (1994).

Conformity Assessment

Given the potential hazards of AIMDs, manufacturers of active implantable medical devices (AIMDs) may choose one of the conformity assessment procedures in accordance with one of the annexes to Government Regulation No. 55/2015 Coll. listed in this table:

Annexes Used for AIMD Conformity Assessment	Abbreviated Title of Annex to Government Regulation No. 55/2015 Coll.
Annex No. 2	EC Declaration of Conformity Full Quality Assurance System
Annex No. 3 together with Annex No. 4	EC Type Examination – Annex No. 3
Annex No. 3 together with Annex No. 4	EC Verification – Annex No. 4
Annex No. 3 together with Annex No. 5	EC type examination – Annex No. 3
Annex No. 3 together with Annex No. 5	EC declaration of conformity Production quality assurance – Annex No. 5

The manufacturer, or the authorized representative, must retain, together with the technical documentation of the quality system, copies of certificates in accordance with Annexes 2 and 3 of Government Regulation No. 55/2015 Coll. for a period of 15 years, and copies of type examination certificates and their addenda for a period of at least 15 years after the manufacture of the last implantable device, including for the use of the competent authorities.

Declaration of Conformity

Prior to placing AIMDs for which conformity has been assessed on the market, the manufacturer shall draw up a written declaration of conformity in accordance with Annexes 2, 4, and 5 of Government Regulation No. 55/2015 Coll.

For custom-made AIMDs and AIMDs intended for clinical trials, the manufacturer shall issue, prior to placing each such device on the market, a written declaration in accordance with the provisions of Annex 6 to Government Regulation No. 55/2015 Coll. The manufacturer shall retain the documentation and declaration referred to in this Annex for a period of at least 15 years after the manufacture of the last active device.

CE Marking

If other directives covering different aspects apply to the AIMD and also require the affixing of the CE marking, then the CE marking on the AIMD indicates that conformity with the provisions of those other directives is also presumed. The manufacturer of an AIMD must affix the CE marking to the product before placing it on the market or putting it into service, provided that it meets the requirements set forth in Government Regulation No. 55/2015 Coll. with regard to its intended use.

The CE marking on the AIMD must be accompanied by the identification number of the notified body that assessed the conformity of the AIMD using one of the procedures specified in Annexes 2, 4, and 5 to Government Regulation No. 55/2015 Coll. The CE marking shall be affixed visibly, legibly, and indelibly to the packaging of the AIMD and to the instructions for use.