Dispositivi medici Classe I - Dichiarazione di conformità MDR

Dispositivi Classe I - Disposizioni transitorie Art. 120 co. 3, 4 MDR

Class I Transitional provisions under Article 120 (3 and 4) – (MDR) March 2020

MDCG 2020-2

Lo scopo di questo documento è di fornire una guida relativa alle informazioni da fornire nella Dichiarazione di conformità da parte dei produttori di dispositivi di Classe I (dispositivi non sterili o che non hanno una funzione di misurazione) che devono essere in possesso di certificati dopo il 26 maggio 2024 secondo la MDR.

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Content of a valid Declaration of Conformity

The manufacturer or his authorised representative established in the European Union is obliged to issue a Declaration of Conformity that the product has undergone a conformity assessment procedure required by the MDD before being placed on the market.
With the Declaration of Conformity, the manufacturer declares that the products concerned meet the relevant provisions of the MDD. MDD Annex II, Annex V, Annex VI set out that a Declaration of Conformity must cover one or more medical devices manufactured  clearly identified by means of product name, product code or other unambiguous reference for class IIa, IIb and III devices, and also class Im and class Is devices. This is however not necessary for other Class I devices, as it is not required by the MDD (Annex VII) and as there is no certificate from a notified body to which the issued Declaration of Conformity is related. Guidance on the content of the Declaration of Conformity can be found, inter alia, in the “The ‘Blue Guide’ on the implementation of EU products rules 2016 (2016/C272/01)” and the standard EN ISO/IEC 17050-1.

According to this standard, the declaration may take the form of a document or any other suitable medium, and should contain sufficient information to enable all products covered to be traced back to it. The model declaration in Annex III of Decision No 768/2008/EC and the ‘Blue Guide’ on the implementation of EU products rules 2016 (2016/C272/01) describe the content of the Declaration of Conformity to be as follows:

1. A number identifying the product. This number does not need to be unique to each product. It could refer to a product, batch, type or a serial number. This is left to the discretion of the manufacturer.
2. The name and address of the manufacturer or the authorised representative issuing the declaration.
3. A statement that the declaration is issued under the sole responsibility of the manufacturer.
4. The identification of the product allowing traceability. This is any relevant information supplementary to point 1 describing the product and allowing for its traceability. Where relevant for the identification of the product, it may contain an image, but unless specified as a requirement in the Union harmonisation legislation this is left to the discretion of the manufacturer. 
5. All relevant Union harmonisation legislation complied with; the referenced standards or other technical specifications (such as national technical standards and specifications) in a precise, complete and clearly defined way; this implies that the version and/or date of the relevant standard is specified.
6. If applicable, the name and identification number of the notified body,13 when it has been involved in the conformity assessment procedure,14 15 and the reference to the relevant certificate.
7. If applicable, all supplementary information that may be required (for example category).
8. The date of issue of the declaration; signature and title or an equivalent marking of the authorised person

- This could be any date after the completion of the conformity assessment, but must be before 26 May 2020 if the manufacturer wants to make use of the transitional period in Article 120(3) and (4) of the MDR.

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Fonte: EU

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