FAQ

There are a few key dates when it comes to the adoption of the MDR:
• Date of Publication: the MDR was published in the Official Journal of the EU (OEJ) on May 5, 2017.
• Date of Entry into force: 20 days after publication of the MDR, the EU regulations “came into force”.
• Date of Application: May 26, 2021, the MDR will apply and the MDD and AIMDD will no longer apply. From this date onwards it is not possible to issue or renew or significantly change any MDD or AIMDD certificate. However the current certificates that still have an expiration date, will still remain effective until the expiration date.

DEKRA has two Notified Bodies for the EU Medical Device Regulation (2017/745, MDR): DEKRA Certification B.V (NB 0344) and DEKRA Certification GmbH (NB 0124).

For every product being sold on the European market, there has to be sufficient clinical evidence. If products currently on the market don't have this evidence, this evidence needs to be obtained. For example by doing clinical research. Speak to your project manager to  receive more info on the need for clinical evidence for the device(s) you introduce(d) into the market.

Clinical data:

• clinical investigation on the device concerned.
• clinical investigation reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated.
• data from the manufacturer’s post-market surveillance system, in particular post-market clinical follow-up.

Clinical evaluation:

• to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

Clinical Evidence:

• the clinical data and clinical evaluation report pertaining to a device.
• sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer.

Besides the personal contact with their DEKRA contact person, we reach out to our customers in a number of ways. Our customers can find info on this website, receive e-mailings about the current developments. We've hosted 3 webinars about the MDR in the last 6 months, covering the topics; Status & Highlights, Clinical Evaluation Requirements and Classification and Conformity Assessment Routes. Have you missed them? Feel free to sign up and watch them via our webinars page

Some new requirements related to the maintenance of the old NB certificates are identified in article 120 of the MDR. This means the NB shall be obliged to verify to some requirements, irrespective of the old/new NB status. As Article 120 indent 3 specifies "However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.

There will be significant changes for manufacturers, we believe some of the biggest challenges will be faced in the following areas: 

- meeting clinical evaluation requirements
- the update of the performance evaluation
- the update of the technical documentation