Informational First NB designated to the EU MDR regulation – BSI UK

Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Interesting (ironic, tragic, twisted?)... with Brexit looming, the BSI UK CE marks may not be recognized. BSI is working with clients that have a cert issued from BSI UK to transfer to their BSI Netherlands office.
 
Thread starter Similar threads Forum Replies Date
M Informational New designated Notified Body for Regulation (EU) 2017/745 (MDR) included in Nando – IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Medical Device and FDA Regulations and Standards News 3
M Informational EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational EU – New notified body designated under the MDR – NB 1912 – DARE!! Services B.V. – Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational EU – New designated Notified Body under the MDR – TÜV Rheinland LGA Products GmbH Medical Device and FDA Regulations and Standards News 0
M Informational EU – Next Notified Body designated to the MDR 2017/475 is IMQ S.p.A from Italy Medical Device and FDA Regulations and Standards News 0
M Informational EU – DEKRA Certification GmbH is the third Notified Body designated under the MDR Medical Device and FDA Regulations and Standards News 0
Watchcat Four NBs now designated under the MDR - August 2019 EU Medical Device Regulations 7
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen Medical Device and FDA Regulations and Standards News 1
Ajit Basrur Informational TÜV SÜD Becomes Second NB to be Designated Under EU MDR EU Medical Device Regulations 0
M Informational EU – First IVDR designated Notified Body – DEKRA Certification GmbH Medical Device and FDA Regulations and Standards News 0
C IATF 16949:2016 Section 8.5.1.2 item d) accessible for use at the designated work area(s) IATF 16949 - Automotive Quality Systems Standard 5
M Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Medical Device and FDA Regulations and Standards News 0
E IATF 16949 Cl. 8.2.3.1.2 - Customer-designated special characteristics IATF 16949 - Automotive Quality Systems Standard 1
D Customer-Designated Special Characteristics vs. Special Characteristics IATF 16949 - Automotive Quality Systems Standard 2
K Plastic Resin designated as Significant Characteristic Manufacturing and Related Processes 7
Q TS 16949 Clause 7.2.1.1 Customer Designated Special Characteristics IATF 16949 - Automotive Quality Systems Standard 6
S Vendor Control for Customer Designated Supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M TS 16949 7.4.1.3 - Difference between Approved Source and Customer Designated Source IATF 16949 - Automotive Quality Systems Standard 2
L Writing a Shipping and Receiving Procedure - Designated Warehouse Locations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Customer Designated vs. Customer Approved? Definitions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
B Customer-designated sources AS9100 Design and Development of Products and Processes 6
S Designated Customer Representative - TS 16949 - Section 5.5.2.1 Design and Development of Products and Processes 3
M Customer Designated Special Characteristics - TS16949 Clause 7.2.1.1 Design and Development of Products and Processes 14
F Advantages of a designated Internal Audit team? General Auditing Discussions 7
M Document Approvals- Designated Alternates Design and Development of Products and Processes 3
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 0
R Products not within the MDR grace period EU Medical Device Regulations 1
shimonv MDR transition checklist EU Medical Device Regulations 0
K Re-packaging under MDR EU Medical Device Regulations 0
Ed Panek Upcoming NB MDD ---> MDR Crunch EU Medical Device Regulations 0
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
N Looking for a recommendation for an EU MDR Importer EU Medical Device Regulations 1
JoCam Rental and MDD versus MDR EU Medical Device Regulations 1
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 3
Raisin picker CECP, consultation according to Art 54 MDR EU Medical Device Regulations 1
K Question on MDR classification EU Medical Device Regulations 4
M STED vs MDR EU Medical Device Regulations 0
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
K Importer in EU, but not distribute in the EU - MDR obligations EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Responsibilities of Importers / Distributors - MDR EU Medical Device Regulations 3
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2

Similar threads

Top Bottom