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  1. pharma services oehler
25 September 2019

Block of Notified Bodies

Just four Notified Bodies according to MDR 2017 / 745 have been named up to now.

It was already clear back in May 2017 that the appointment of Notified Bodies under MDR 2017/745 would cause a bottleneck. At the moment, merely four Notified Bodies have been appointed (compared to 57 previously), one of which is in the UK.

All certificates for higher class medical devices, if possible, should, therefore, be renewed again under the old guideline to be able to profit from the four additional years this interim solution offers. The Declarations of Conformity for class I devices need to be ready by the 26 May 2020.

It will be critical for products that will be moved from class I to a higher class through the MDR and as a result, will require a reassessment from a Notified Body. Many substance-based medical devices (for example, creams or throat sprays / tablets) are affected by rule 21.

For more information, please fill out the enquiry form attached to this page.

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