For legal manufacturers of in vitro diagnostic devices we offer conformity assessment procedures according to Regulation (EU) 2017/746 (IVDR) as a Notified Body (EU Identification Number „0483“). The regulation applies throughout the EU and replaces the former Directive 98/79/EC since 2017. Conformity assessment procedures according to Annex IX of Regulation (EU) 2017/746 (IVDR) with Notified Bodies are mandatory for all manufacturers of Class A (sterile), B, C and D devices as well as near-patient tests and devices for self-testing by lay persons.
Our main activities in this area are not only on-site audits of the quality system for manufacturers and their subcontractors, but also the assessment of Technical Files of the respective products as well.
For this activity we provide beside our trained auditors a range of experts experienced for years in industry, research institutions, laboratories or at Notified Bodies. For the verification of manufactured products in the area of high-risk devices according to Annex IX, section 4.12, we support the manufacturer in cooperation with the EU reference laboratories designated according to Article 100.
Also in the area of in vitro diagnostic devices the voluntary certification according to QM standards is of particular interest. Manufacturers of class A products (non-sterile), components and raw materials receive an assessment of their QM system against the background of the requirements of Regulation 2017/746 or the corresponding national laws as part of certification in accordance with ISO 13485.
As well as in the area of medical devices for subcontractors and suppliers of components and semi-finished products a certificate according to EN ISO 13485, issued by a registrar, who is recognized as a Notified Body, is a real benefit.
Beside the fact, that manufacturers usually consider the availability of a certificate according to EN ISO 13485 as evident, also the frequency of suppliers audits performed by their Notified Bodies decreases significantly.