EU DOC complying to EU MDR

The below is extracted from EU MDR. Using surgical mask as an example, please see below how we can draft the EU DOC complying to EU MDR:

The EU declaration of conformity shall contain all of the following information:

1. Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;

Manufacturer 

Compliance Management Solutions Pty Ltd

109 Ridgemont Drive

Berwick VIC 3806 Australia

European Authorized Representative 

CMS Europe:

Compliance Management Solutions Europe Ltd

2 Bulgaria Street

2850 Petrich BULGARIA

SRN: Not Available Yet

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

We, the manufacturer, herewith declare that it is under our sole responsibility that the following product(s) are in conformity with the Medical Device Regulation 2017/745.

3. The Basic UDI-DI as referred to in Part C of Annex VI;

Show the UDI number and/ or barcode. 

4. Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identifi­cation and traceability may be provided by the Basic UDI-DI referred to in point 3;

Product/ Trade Name: CMS Medtech Surgical Mask etc

Model number: CMS M1

Show a photograph of mask and/ or its packaging

This intended purpose is normally to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar
requirements. A medical face mask with an appropriate microbial barrier should also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.

5. Risk class of the device in accordance with the rules set out in Annex VIII;

Rule 1

6. A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;

Re-phrase the above to:

We, the manufacturer, herewith declare that it is under our sole responsibility that the following product(s) are in conformity with the Medical Device Regulation 2017/745 and PPE Regulation (EU) 2016/425 .

7. References to any CS used and in relation to which conformity is declared;

Only if there are CS available; there are none with respect to surgical mask at the moment. See list of harmonized standards in the appendix:

Example of harmonized standards are but not limited to: ISO13485: 2016, ISO 14971: 2019, EN 1041:2008+A1:2013, EN ISO 15223-1:2016, EN ISO 10993-1:2018, EN 14683: 2019, EN 1041:2008+A1:2013

8. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;

 No notified body is  involved because product is CE self declared via Annex II and Annex III of Medical Device Regulation 2017/745

9. Where applicable, additional information;

10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.

Place of Issue: Australia

Date of Issue:  Aug 19th 2020

signed on behalf of manufacturer by
Name: George Loizou
Title: Director of Compliance Management Solutions Pty Ltd