DQS approved as Notified Body for MDR

DQS MED has been appointed by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) for procedures based on the EU Medical Devices Regulation VO (EU) 2017/745 (MDR). With the anticipated publication in the NANDO database (MDR Article 42 (11) and (12)) in the coming weeks, DQS MED will officially start our activities as a Notified Body for MDR, on the basis of many years’ experience for MDD.

Of the 46 Notified Bodies that currently applied for designation under the MDR, only 40 had a branch audit by the competent national and European authorities and only 25 Notified Bodies subsequently submitted a CAPA plan. It can therefore be assumed that by the end of the transition period on 25 May 2021, significantly fewer Notified Bodies than today will be able to offer their services against MDR.

DQS Med will continue to be a reliable and competent partner for our clients in the field of medical device CE Marking approvals.

DQS Service

DQS is a certified body for ISO 9001:2015, ISO 13485:2016 and MDSAP. DQS is also an authorized notified body for CE marking under EU MDD and MDR.

DQS Academy provides training courses of internal auditors and lead internal auditors for ISO 9001 and ISO 13485, to equip the clients with the knowledge to implement an effective medical QMS in the organization.