+ANNEXE IV Déclaration UE de conformité
---+1. The name of the EHR system, version and any additional unambiguous reference allowing …
---+2. Name and address of the manufacturer or, where applicable, its authorised representative.
---+3. A statement that the EU declaration of conformity is issued under the sole responsibility of the …
---+4. A statement that the EHR system in question is in conformity with the provisions laid down in …
---+5. References to any relevant harmonised standards used and in relation to which conformity is …
---+6. References to any common specifications used and in relation to which conformity is declared.
---+7. Place and date of issue of the declaration, signature plus name and function of the person who …
---+8. Where applicable, additional information.

ANNEXE IV Déclaration UE de conformité

ANNEXE IV

Déclaration UE de conformité

La déclaration UE de conformité pour les composants logiciels harmonisés d’un système de DME contient l’ensemble des informations suivantes:

1)

le nom du système de DME, la version et toute référence sans équivoque supplémentaire permettant d’identifier le système de DME;

2)

le nom et l’adresse du fabricant ou, le cas échéant, de son mandataire;

3)

une déclaration attestant que la déclaration UE de conformité est délivrée sous la seule responsabilité du fabricant;

4)

une déclaration attestant que le système de DME en question respecte les dispositions établies au chapitre III et, le cas échéant, toute autre disposition du droit de l’Union applicable prévoyant la délivrance d’une déclaration UE de conformité, complétée par les résultats de l’environnement d’essai mentionné à l’article 40;

5)

des références aux normes harmonisées pertinentes qui ont été utilisées et par rapport auxquelles la conformité est déclarée;

6)

des références aux spécifications communes qui ont été utilisées et par rapport auxquelles la conformité est déclarée;

7)

le lieu et la date de délivrance de la déclaration, la signature, le nom et la fonction du signataire et, le cas échéant, une indication de la personne au nom de laquelle elle a été signée;

8)

le cas échéant, des informations supplémentaires.

1. Vue d’ensemble

,
Intitulé Réglementation
1. The name of the EHR system, version and any additional unambiguous reference allowing …

1.

The name of the EHR system, version and any additional unambiguous reference allowing identification of the EHR system.

2. Name and address of the manufacturer or, where applicable, its authorised representative.

2.

Name and address of the manufacturer or, where applicable, its authorised representative.

3. A statement that the EU declaration of conformity is issued under the sole responsibility of the …

3.

A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer.

4. A statement that the EHR system in question is in conformity with the provisions laid down in …

4.

A statement that the EHR system in question is in conformity with the provisions laid down in Chapter III and, if applicable, with any other relevant Union law that provides for the issuing of an EU declaration of conformity, complemented by the result from the testing environment mentioned in Article 40.

5. References to any relevant harmonised standards used and in relation to which conformity is …

5.

References to any relevant harmonised standards used and in relation to which conformity is declared.

6. References to any common specifications used and in relation to which conformity is declared.

6.

References to any common specifications used and in relation to which conformity is declared.

7. Place and date of issue of the declaration, signature plus name and function of the person who …

7.

Place and date of issue of the declaration, signature plus name and function of the person who signed and, if applicable, an indication of the person on whose behalf it was signed.

8. Where applicable, additional information.

8.

Where applicable, additional information.

1.1 Références

1.2 Exigences identifiées

1.3 Normes associées

2. Exigences identifiées

Exigences
Source Exigence

3. Normes associées

Normes
Source Exigence
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