The European regulations on medical devices (MDR – Regulation (EU) 2017/745) and on in-vitro diagnostics (IVDR – Regulation (EU) 2017/746) define market access requirements for medical devices. The manufacturer is responsible for assessing and confirming fulfilment of the requirements. On this basis, he can declare conformity with the legal requirements, issue a declaration of conformity and may affix the CE mark as proof.

With the CE mark, the manufacturer documents that his products fulfil the full conformity with the legal requirements and that the prerequisites for placing the products on the market or putting them into operation on the European market have been met. The CE mark is therefore proof of the conformity of a medical device with the EU MDR and IVDR regulations. To prove this, the medical device manufacturer must establish a quality management system that ensures, among other things, the implementation of a risk management process (minimisation of risks) and a clinical evaluation (MDR) / performance evaluation (IVDR) for each product.

In the simplest case (Class I medical devices or Class A in-vitro diagnostics – products with a particularly low risk), this conformity assessment is carried out by the manufacturer on their own responsibility.
With increasing product risk (risk classes IIa, IIb and III or classes A steril, B, C and D), independent conformity assessment is not sufficient. The manufacturer must also involve a Notified Body in the conformity assessment procedure, who evaluates manufacturer’s results and monitors the manufacturer’s activities.

In the field of CE marking, we offer a wide range of products for the conformity assessment procedures of a wide variety of products under Regulation (EU) 2017/745 for medical devices (MDR) and Regulation (EU) 2017/746 for in vitro diagnostics (IVDR).