For manufacturers of in-vitro diagnostics, we carry out the certifications required for CE marking 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. Our activities here focus on both the inspection of the QM system at the manufacturer’s premises and its subcontractors as well as 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 experts with many years of expertise in industry, research institutes, laboratories and notified bodies at our disposal. Genomics, proteomics, glycomics, lipidomics and metabolomics are no foreign words to us!
For the mandatory testing of individual batches of manufactured products, we support the manufacturer in co-operation with notified EU reference laboratories.
Our cooperation partners in Ukraine recognise mdc certifications for national product approval.

Certification in accordance with EN ISO 13485 is also particularly important for manufacturers of in-vitro diagnostics that do not require certification. In these cases, manufacturers receive an assessment of their QM system against the background of regulatory requirements.
ISO 13485 is the normative basis for the Medical Device Single Audit Programme (MDSAP) and recognition in Taiwan by the Technical Cooperation Programme (TCP).