The NANDO database newly lists 26 Notified Bodies under the MDR!
TÜV NORD CERT GmbH has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.
TÜV NORD CERT GmbH
Langemarckstraße 20
45141 Essen
Germany
Phone : +49 (0) 201 825-3262
Fax : +49 (0) 201 825-3290
Email : info@tuev-nord.de
Website : www.tuev-nord-cert.de
You can find the full scope of its notification on the following link. Below, an extract from NANDO, where conditions are listed :
- MDS 1001 Devices incorporating medicinal substances
- Without medicinal products derived from human blood or human plasma
- MDS 1005 Devices in sterile condition
- Including: aseptic processing; ethylene oxide gas sterilisation (EOG); low temperature steam and formaldehyde sterilisation; moist heat sterilisation; radiation sterilisation (gamma, x-ray, electron beam); sterilisation with hydrogen peroxide; additional: Sterilisationsverfahren mit Plasma
- …
Also, have a look at the Analysis of NB Designation prepared by our partners AKRA TEAM. You will find it in our dedicated Library of Documents – Notified Body: MDR and IVDR.
SWITZERLAND: Reached agreement between Swiss Medtech and Swiss CA
The Swiss medical technology industry and patient care association (Swiss Medtech) has reached an agreement with the Swiss authorities (FOPH (BAG) & Swissmedic). This has resulted in different labelling requirements for MDD/AIMD and MDR devices such as:
- MDD/AIMD devices (all classes) can have the importer and CH-REP listed in a delivery note/packaging slip. Therefore, the obligation to be stated in a declaration directly on product, packaging or IFUs is not required anymore.
- The above requirement is also established for importers for MDR devices (all classes). Nevertheless, the CH-REP will still need to be indicated on the label, except for MDR Class I devices, which enjoy a transitional period until 31 July 2023 (the CH-REP indication on the delivery note/packing slip suffices). Swiss MedTech nevertheless recommends to already indicate the CH-REP on a device label, as part of the transition to the new Regulation.
As a result of this agreement, MedDO’s obligations for economic operators have been updated (please see below an extract). These changes intend to also alleviate the existing supply problems the Swiss market is experiencing.
Source of image: Swissmedic, 2021
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