DEKRA Certification B.V. is a designated Notified Body under the New In-Vitro Diagnostics Regulation
DEKRA Certification B.V. is now recognized as a Notified Body by the European Commission under the new EU regulation on in-vitro diagnostics (IVDR 2017/746).
DEKRA Certification B.V. is now recognized as a Notified Body by the European Commission under the new EU regulation on in-vitro diagnostics (IVDR 2017/746). This further strengthens DEKRA in the field of medical certification. As a result, DEKRA remains a reliable, competent partner for medical device manufacturers, both in the run-up to the new Regulation and beyond the implementation date of 26 May 2022. Under this new regulation, considerably stricter requirements will apply to manufacturers of in-vitro diagnostics (IVDs) in the European Union.
IVDs are medical products for testing of human samples. In the new Regulation (EU) 2017/746, the provisions on EU market access have been made considerably stricter. Many products for which a self-declaration was previously sufficient will require approval by a Notified Body from 2022 onward. There are also stricter rules on documentation, performance evaluation and monitoring.
The primary aim of the new regulation is to ensure better protection of public health and patient safety. Generally speaking, the new rules are based around an increased focus on clinical performance, better traceability of medical devices and more transparency for patients. For industry actors, however, this means tighter restrictions will be imposed on IVD medical devices entering the European market. Manufacturers, importers and distributors could find that the new rules place their medical devices in a higher risk category than before. As a result, not only new products but also existing ones need to comply with more stringent requirements – including stricter demands in terms of clinical evidence – in order to qualify for marketing authorization. In many cases, this could entail re-certification.
The global medical device team of DEKRA has extensive expertise in a wide array of medical and in vitro diagnostic devices and technologies. This enables the company to act as a single partner to support customers around the world with product certification and quality management system assessments.
For more information about IVDR please visit our webpage about Medical Device Regulatory Services.