The NANDO database newly lists 25 Notified Bodies under the MDR!
SGS Belgium NV has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.
SGS Belgium NV
Noorderlaan 87
BE-2030 Antwerpen
Country : Belgium
Phone : +32(0)3 545 48 60
Fax : –
Email : NB1639@sgs.com
Website : www.be.sgs.com
Notified Body number : 1639
You can find the full scope of its notification on the following link. Below, an extract from NANDO, where conditions are listed :
- MDA 0201 Active non-implantable imaging devices utilising ionizing radiation, MDA 0301 Active non-implantable devices utilising ionizing radiation
- Excluding surgically invasive devices for transient/short term use utilising ionizing radiation
- MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
- Excluding heart valves
- MDN 1104 Non-active soft tissue and other implants
- Excluding breast implants – Excluding implants and long term invasive devices utilising ionizing radiation
- MDN 1207 Non-active non-implantable diagnostic devices
- Excluding non-active devices for ingestion
- MDN 1103 Non-active dental implants and dental materials
- MDN 1207 Non-active non-implantable diagnostic devices
- MDS 1005 Devices in sterile condition
- Including: – aseptic processing – ethylene oxide gas sterilization – moist heat sterilization – radiation sterilization (gamma, x-ray & electron beam) – gas plasma sterilization
- MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin
- Excluding devices manufactured using processing of materials of human origin
- MDS 1007 Devices incorporating or consisting of nanomaterial
- Limited to orthopaedic and cardiovascular devices
- ..
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.
EUDAMED
The Commission Implementing Regulation on European Database on Medical Devices (Eudamed) has been published today in the Official Journal of the EU (29.11.2021).
It provides certain useful definitions, such as:
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(2) |
‘authorised user’ means a natural person who has been granted access to Eudamed via the restricted website to act on behalf of an actor; |
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(3) |
‘local actor administrator’ (LAA) means an authorised user who has the right to manage certain information regarding the details of the actor and to grant access to Eudamed via the restricted website to other natural persons to act on behalf of that actor; |
|
(4) |
‘local user administrator’ (LUA) means an authorised user who has the right to grant access to Eudamed via the restricted website to other natural persons to act on behalf of an actor; |
More specifically, the Implementing Regulation governs:
- Mode of access:
- The restricted website for authorised users only and
- The public website for the general public;
- Process of registration of an actor, notified body, sponsor:
- Noting that the first authorised user of an actor shall automatically be the first LAA of that actor; and any additional users shall be approved by the LAA or LUA of that actor.
- Notified Bodies will be registered to EUDAMED by the European Commission, taking the information from NANDO.
- Nomenclature: User shall use the European Medical Device Nomenclature (EMDN), which shall be free of charge;
- Technical and administrative support
- Ownership and processing of personal data with the following categories of data being processes:
- Names of actors and authorised users;
- Contact details of actors and authorised users;
- Identification and contact details, and data on professional qualifications of other natural or legal persons, which shall be reported in Eudamed for the purpose of complying with the obligations set out in Regulations (EU) 2017/745 and (EU) No 2017/746.
- Functioning rules: Accessible at all times, except during necessary and previously announced downtime periods due to maintenance activities, including new releases.
- Malfunction: The actor or an authorised user that suspects a malfunction shall immediately inform the Commission.
- Websites for testing and training purposes: Data entered in these websites shall be considered fictitious and not available to the public.
- IT Security
- Fraudulent user activity within Eudamed: Any actor or authorised user shall without delay inform the Commission and the Member States of the suspected fraudulent activity via the application support team (dedicated functional mailbox).
The full text of the Commission Implementing Regulation is available in our Library – EUDAMED and European Commission.
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