OpenRegulatory Template

EC Declaration of Conformity

Manufacturer

<Company Name>

<Company Address>

Medical Device

<Name of Device>

<Version of Device>

<Basic UDI-DI, if applicable>

Classification

Medical Device Class: <enter class>

Classification based on <enter MDR reference, for example: Annex VIII, Chapter 3, Paragraph 6, Rule 13 (for class I active devices)>.

For context, read Chapter 5, Section 1, Art. 51 MDR. You can find the classification rule applicable to your medical device set out in Annexes VIII of the MDR.

For example: software intended to provide information used to take decisions with diagnosis or therapeutic purposes and software intended to monitor physiological processes is classified as class IIa according to rule 11 of the Annex.

Conformity Assessment

Conformity assessment procedure: <enter reference to applicable Annex, for example for class I: Annex I and III> of the Regulation (EU) 2017/745.

For context, read Chapter 5, Section 2, Art. 52 MDR. You can find the conformity assessment procedures applicable to your medical device class set out in Annexes IX to XI of the MDR:

The Medical Device referenced above meets the provisions of Regulation (EU) 2017/45 on medical devices.

Note #1: This document needs to be signed in some way. If you’re using software which supports electronic signatures, use it to sign this document. Otherwise, print it out, sign it old-school, scan it and upload it to your QMS folder.

Note #2: read Annex IV MDR to double-check if all relevant information is included! For example, if applicable, include product / trade name, Notified Body information, etc.


Place, Date, Signature of CEO


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