The correct route for the confor­mity assess­ment proce­dure depends on the valid legal basis for medical devices. Currently, two EU regu­la­tions are in force, as there is a tran­si­tional period until the new EU Medical Device Regu­la­tion comes into appli­ca­tion. Up to 25 May 2021, the EU Medical Devices Direc­tive 93/42/EEC is still applic­able. Beyond this date, certi­fied and regis­tered medical devices can still be sold for 4 years without the manu­fac­turer being allowed to make rele­vant changes.

The Euro­pean Regu­la­tion on Medical Devices (MDR) 2017/745 and 2017/746 on in-vitro diag­nos­tics will apply with the cut-off date of 26 May 2021. If a Noti­fied Body is already desig­nated for certi­fi­ca­tion proce­dures according to MDR and a contrac­tual rela­tion­ship exists between this body and a manu­fac­turer, CE-certi­fi­ca­tion according to the Medical Devices Regu­la­tion can take place. Accord­ingly, manu­fac­turers can currently carry out confor­mity assess­ment between two Euro­pean legal frameworks.

However, the neces­sary require­ments do not differ signif­i­cantly. The require­ments to be fulfilled are termed Essen­tial Require­ments in the MDD (Annex I), whereas the MDR describes them as Essen­tial Safety and Perfor­mance Require­ments (cf. Annex I). Every manu­fac­turer must fulfil these for their medical devices! The respec­tive confor­mity assess­ment proce­dures (MDD Annexes II-VI; MDR: Annexes IX-XI) deter­mine which further aspects must also be consid­ered. The choice for the appro­priate proce­dure depends on the clas­si­fi­ca­tion of the medical device. The following figure shows the options avail­able to medical device manufacturers.

After a successful confor­mity assess­ment proce­dure, the manu­fac­turer can issue a decla­ra­tion of confor­mity and sign the respec­tive device with a CE marking according to Annex XII (MDD) or Annex V (MDR).

If you would like to find the right confor­mity assess­ment proce­dure for your medical device, please contact us! We are happy to support you!!

If you wish, we can accom­pany you through the entire certi­fi­ca­tion process. You set the pace and the type of cooperation!

We Value Your Privacy
We use cookies on our website. Some of them are essential, while others help us to improve this website and your experience.
Privacy Settings
Statistics
We use these technologies to analyze how this website is being used.
Name Google Analytics, Google Tag Manager
Provider Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland
Purpose Cookie by Google used for website analytics. Generates statistical data on how the visitor uses the website.
Privacy Policy https://policies.google.com/privacy
Cookie Name _ga, _gat, _gid
Cookie Expiry 2 years
Customer Interaction
These technologies will allow you to contact us through our website, i.e. use the chat widget.
Name LiveChat
Provider LiveChat Software S.A., ul. Zwycięska 47, 53-033 Wroclaw, Poland
Purpose Communication with clients via online chat using the API of the chat service LiveChat.
Privacy Policy https://www.livechat.com/legal/privacy-policy/
Cookie Name __lc_cid, __lc_cst
Cookie Expiry 2 years
Essential
Technologies required to enable the core functionality of this website.
Name Cookie Consent
Provider Owner of this website, Imprint
Purpose Saves the visitors preferences selected in the cookie banner.
Cookie Name ws_cookie_consent
Cookie Expiry 1 year