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© DEKRA CERTIFICATION B.V.
DEKRA Certification B.V. has officially received approval as a Notified Body (NB 0344) in accordance with the European Medical Device Regulation 2017/745 (MDR). This further strengthens the company 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 and beyond the MDR implementation date of 26 May 2020.
When the new Regulation on Medical Devices (MDR) came into force on May 2017, medical device manufacturers had a three-year period to make the necessary preparations for the transition. The MDR will replace the current Medical Device Directive (93/42/EEC) (MDD) and Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD) on 26 May 2020.
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 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 may 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.
DEKRA firmly believes that the MDR designation further enhances its comprehensive range of product certification and quality management system assessments and will enable them to continue to be a reliable, competent partner for medical device customers, both now and in the future.
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 our customers around the world with product certification and quality management system assessments. For example, DEKRA has extensive experience of conducting audits within the Medical Device Single Audit Program (MDSAP), and has an excellent understanding of the requirements of the participating Regulatory Authorities: TGA in Australia, ANVISA in Brazil, Health Canada, MHLW and PMDA in Japan, and FDA in the USA.