Regulation on Medical Devices(MDR)

Parliament adopted the Commission proposal on 17 April, allowing the application of the Medical Devices Regulation to be postponed by one year until 26 May 2021.

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 has officially received approval as the Notified Body (NB 0344 and NB 0124) in accordance with the European Medical Device Regulation 2017/745 (MDR).

• Global presence
• All testing and certificates provided by a single organisation. In addition to the AIMD Directive, you can also call on us for IEC 601 tests and ISO 13485 certification.
• We are specialists with extensive experience in the medical industry
• You have one permanent contact throughout the process
• We participate in all MRAs (USA, Japan, Taiwan and Australia)
• We are experts in drug/device combinations and products containing animal material
• We have developed a special programme that helps you into market
• If you are dissatisfied with the service you receive from your current Notified Body, we have experience in assuming certificates