Regulation (EU) 2017/746 on medical devices: The IVDR regulation is the applicable regulatory basis for in-vitro diagnostics (IVD) on the European market.
As one of the few Notified Bodies in Europe, mdc medical device certification GmbH is your competent partner for CE certification in accordance with the new regulations (EU) 2017/746. For manufacturers of in-vitro diagnostics, we carry out the certifications required for CE labelling in accordance with Regulation (EU) 2017/746 as a Notified Body. Conformity assessment procedures with Notified Bodies are mandatory for all manufacturers of class A (sterile) and class B, C and D devices. Our services also include the certification of patient-related tests and products for self-use by laypersons.
The focus of our activities here is both the inspection of the QM system at the manufacturer's premises and its subcontractors and the inspection of the technical documentation for the respective products in accordance with Annex IX. In addition to auditors with product and technology experience, we have qualified technical experts with many years of expertise in industry, research institutes, laboratories and notified bodies at our disposal. For the mandatory testing of manufactured products, we support the manufacturer in co-operation with notified EU reference laboratories.
