What is a proof of conformity?

Evidence of conformity proves that certain requirements, for example of a standard, are met. The guide to auditing management systems, ISO 19011, starts by talking about "objective evidence," which is "data [that] confirms the existence or truth of something."

What is a conformity assessment procedure for medical devices?

In principle, medical devices must bear a CE mark in order to be placed on the market for the first time in the European Economic Area. The CE-marked medical device must meet the essential requirements of the European Regulation (EU) 2017/745 for safety, performance and health safety and this must be documented in writing as part of the conformity assessment. The conformity assessment procedures and their implementation are regulated in the Medical Devices Regulation. Depending on the risk class of the product, conformity is assessed and verified by the manufacturer themselves or with the assistance of a notified body.

Which conformity assessment procedure is to be carried out and to what extent an independent testing and certification body (notified body) is to be involved depends on the potential risk of the products. Regulation (EU) 2017/745 (MDR) provides for a differentiation of devices into 4 classes (I, IIa, IIb, III). The classification and the conformity assessment procedure to be applied are based on the criteria set out in Annex VIII of Regulation (EU) 2017/745.

Notified bodies carry out the prescribed tests and issue the necessary certificates. Manufacturers can contact a Notified Body of their choice that is designated for the relevant procedure and product category. DQS Medizinprodukte GmbH (DQS MED) is a Notified Body (identification number 0297) of the European Union and is allowed to perform conformity assessments according to the EU Regulation, which are mandatory for all products manufactured in and imported into the EU. We perform conformity assessment procedures according to the Medical Devices Regulation Annex XI and XI Part A and check the technical documentation against the requirements of Annexes II and III of Regulation (EU) 2017/745.