IVDR – Regulation (EU) 2017/746
CE marking is the medical device manufacturer’s claim that a device meets the General Safety and Performance Requirements (GSPR) of the In Vitro Diagnostics Regulations RE(EU) 2017/746. QMD Services offers conformity assessment activities necessary to comply with this regulation. Our review processes allows you to build reliability and confidence into your CE marking project.
QMD Services offers conformity assessment activities as published in NANDO under number NBxxxx. We accept applications, submission of documentation and any related correspondence in English and German language.
HOW TO APPLY FOR CERTIFICATION
Following an initial discussion with our Customer Service Team, you will need to submit us a pre-application form. This gives us the information about your company and products we need to check if we can offer you our services.
For us, to understand which requirements you need to meet, you have to classify the device and identify the appropriate conformity assessment route for your product. This dictates the required activities to demonstrate conformity. We will review the route you chose to confirm its suitability, and provide you with a budget estimate for our services.
For concluding a service contract we require an application signed by the legal manufacturer or an authorised representative containing all of the information and the manufacturer’s declarations required by the relevant conformity assessment as referred to in Annexes IX and XI. Our application form will support you to provide the complete, necessary documents.
Our QMD Services project leader will review your application and resulting contract for completeness, requesting any additional information required.
Documents should be submitted via the secure QMD Services Upload Portal. The preferred document format is a paginated, bookmarked PDF utilizing Optical Character Recognition (OCR, searchable format).
Note: If the application has to be rejected, now or at a later point in time, for technical or formal reasons, or, if you decide to withdraw it, we have to fulfil our reporting obligations according to VO (EU) 2017/746.
Good To Know
QMD Services GmbH
1010 Vienna, Austria
Tel.: +43 1 533 0077
Am Winterhafen 1
4020 Linz, Austria
+43 1 5330077