Conformity assessment procedure

Depending on the class of medical device, the manufacturer may choose the procedure for assessing the conformity of the device. The various procedures are governed by the Annexes to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ C 133, 11.12.1993, p. 1). U. L 169, 12.7.1993, p. 1) and in the Regulation of the Minister of Health of 12 January 2011 on the essential requirements and procedures for assessing the conformity of medical devices (Journal of Laws and Regulations). 24 January 2011). As the above-referred Directive states in its preamble, 'conformity assessment procedures for Class I devices may, as a general rule, be carried out in the face of a low level of sensitivity associated with those devices under the sole responsibility of manufacturers; for class IIa products, the intervention of the notified body should be mandatory at the manufacturing stage; For devices which are subject to Classes IIb and III and which present a high potential for danger, control of the notified body with regard to the design and manufacture of the devices is required; Class III shall be reserved for the most dangerous devices which require an express marketing authorisation.'

Therefore, the above-above Regulation precisely regulates the manufacturer's capabilities in this area, since, depending on the class of medical device, he carries out an assessment of compliance with the procedure:

(1) Class III medical devices, other than custom-made devices and clinical trial devices:

(a) the EC declaration of conformity – the full quality assurance system as set out in Annex 2 to the Regulation, or

(b) the EC type-examination referred to in Annex 3 to the Regulation, including the procedure:

– ec verification as set out in Annex 4 to the Regulation, or

– ec declaration of conformity – ensuring the quality of production – as set out in Annex 5 to the Regulation.

(2) class IIb medical devices, other than custom-made devices and clinical trial devices:

(a) ec declaration of conformity – full quality assurance system as set out in Annex 2 to the Regulation, excluding
specific provisions relating to the evaluation of the project, or

(b) an EC type-examination – as defined in Annex 3 to the Regulation – including one of the following procedures:

– ec verification – as set out in Annex 4 to the Regulation,

– the EC declaration of conformity – ensuring the quality of production as set out in Annex 5 to the Regulation,

– ec declaration of conformity – product quality assurance – as set out in Annex 6 to the Regulation.

(3) class IIa medical devices, other than custom-made devices or clinical trial devices:

the EC declaration of conformity – referred to in Annex 7 to the Regulation – including one of the following procedures:

– ec verification – as set out in Annex 4 to the Regulation;

– the EC declaration of conformity – ensuring the quality of production as set out in Annex 5 to the Regulation;

– the EC declaration of conformity – product quality assurance as set out in Annex 6 to the Regulation.

or instead of the above-above procedure, where a full quality assurance system is applied to these products, the application of the procedure:

– the EC declaration of conformity – the full quality assurance system as set out in Annex 2 to the Regulation, with the exception of certain provisions concerning the evaluation of the project.

(4) Class I medical devices, other than custom-made devices and clinical trial devices:

– the EC declaration of conformity as set out in Annex 7 to the Regulation.

(5) custom-made devices or clinical trial devices:

– before each unit is placed on the market or before the start of clinical trials, the manufacturer shall carry out a conformity assessment and draw up a declaration confirming that the device complies with the essential requirements relating there to it or indicating which of the essential requirements have not been met, giving reasons, in accordance with Annex 8 to the Regulation.

It should also be noted that any operator which, for the purpose of placing on the market, sterilises a system or treatment set or medical device already marked with the CE mark intended by the manufacturer for sterilisation before use, with a view to placing it on the market:

(1) carry out a conformity assessment using the procedure:

(a) the EC declaration of conformity – the full quality assurance system set out in Annex 2 to the Regulation, or

(b) ec declaration of conformity – quality assurance of production as set out in Annex 5 to the Regulation

– relating to the obtaining and maintenance of sterility until the packaging is opened or damaged and to the activities of the notified body in this respect;

(2) draw up a declaration at the end of the procedure in which it states that the sterilisation has been carried out in accordance with the manufacturers' instructions.

Ordinally, it is also worth mentioning the annexes to this Regulation concerning the conformity assessment procedure, together with the assignment of appropriate procedures to them:

  • Annex 2 – EC declaration of conformity – full quality assurance system;

– the manufacturer shall ensure the use of an approved quality assurance system, including the design, manufacture and final inspection of the medical devices inspected and subject to audits and evaluation and the supervision of the notified body,

  • Annex 3 – EC type-examination;

– the procedure by which the notified body shall satisfy and certify that a sample of medical devices representative of the intended production complies with the requirements relating to those devices,

  • Annex 4 – EC verification;

– the procedure where by which the manufacturer or his authorised representative declares and ensures that the medical devices which have been the subject of the appropriate procedure conform to the type specified in the EC type-examination certificate and that they comply with the requirements relating to those devices. The notified body shall carry out appropriate checks and tests to verify the conformity of medical devices with the requirements relating there to them, or by checking and examining each medical device or by checking and examining batches of medical devices using statistical methods;

  • Annex 5 – EC declaration of conformity – quality assurance of production;

– the manufacturer ensures the use of an approved quality system, including the manufacture and final inspection of the medical devices inspected, and is subject to the supervision of a notified body;

  • Annex 6 – EC declaration of conformity – product quality assurance;

– the manufacturer ensures the use of an approved quality system, including the final inspection and final examination of the medical device and is subject to the supervision of a notified body,

  • Annex 7 – EC declaration of conformity;

– the procedure by which the manufacturer or his authorised representative ensures and declares that the medical devices in question comply with the requirements relating to them.

It should be stressed that the procedures set out in Annexes 2 to 6 require the participation of a notified body in the evaluation. In that case, the manufacturer may employ any notified body within the European Union, bearing in mind, however, that those bodies have different notification scopes.


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