DEKRA Chosen As 3rd Notified Body Under MDR

DEKRA, the German-based company, has been chosen by The European Commission as the third notified body to be accredited under the Medical Device Regulations (MDR).  The new regulations come into effect on May 26th 2020. Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here. Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here. DEKRA’s accreditation to act as a notified body comes amidst considerable disquiet within the medical devices sector about the delay in accrediting new Notified Bodies and the fact that, to date, only 3 have been accredited.  DEKRA will join TÜV SÜD and BSI as the only NB’s designated and listed in The European Commission’s NANDO database (New Approach Notified and Designated Organisations ). In recent months we have been working with several companies that have been forced to identify a new NB following the decision of LRQA to exit the Notified Body sector.  The LRQA notified customers in June 2019 that they planned to exit the sector.  Customers were then given 90 days in which to identify a replacement NB. Acorn Regulatory has been assisting medical device companies in choosing a new Notified Body.  If you would like to speak to our medical device experts then please get in touch with us by contacting us on 00353 5261 76 706 or by completing the webform below. [ninja_form id=1]

MDR Resources from Acorn Regulatory

We have published several articles about the new medical device regulations (MDR) and you can read them by clicking the links (in orange):

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.

Get The Acorn Regulatory Medical Device Regulations Whitepaper

The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations.  For many companies there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read more here.

Understanding MDR: 8 Important Changes

The advent of the new Medical Devices Regulation (MDR 2017/745) in May 2020 is a cause of much concern for manufacturers and others in the devices sector.  The new regulations will bring about many changes compared to the current regulatory framework.  Acorn Regulatory, in this article, will look at the basics of the new MDR and the changes that will impact the device sector from May 26th, 2020. Read more here.

Brexit & Notified Bodies – What Are The Implications for the Medical Devices Sector?

The implications of Brexit will, possibly, be felt most in the area of Notified Bodies.  The UK’s exit from the European Union means that UK based Notified Bodies will no longer be permitted to provide conformity assessment services and issue CE Certificates of Conformity to manufacturers.    There is no doubt that the upheaval caused by this will have an impact on the sector.  Anecdotal evidence already suggests that Notified Bodies within the remaining EU27 members states are experiencing increased demands on their services and they are unable to meet demand in as quick a time as customers would like. Read more here.