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So far PascalePerspectives has created 96 blog entries.

General assembly meeting

On October 11th general assembly meeting, Team-NB decided to suspend the audits against the Code of Conduct in order to work on the preparation of interpretations on MDR requirements in an objective of harmonisation.

By |October 13th, 2016|news|0 Comments

In the framework of the new Medical Device Regulations,

you will find below the Team-NB members’ intention to submit their application to be designated against MDR and/or IVDR. The Team-NB notified body members have a double advantage to pass their designation audit :   The peer review against the Code of Conduct which requirements are ahead of the today ones. The working groups reviewing [...]

By |July 18th, 2016|news|0 Comments

New press release

concerning the adoption of MD draft regulations by ENVI group   TEAM-NB Press Release

By |July 8th, 2016|news|0 Comments

Survey sector

on the basis of members data are available in documents 2016

By |May 17th, 2016|news|0 Comments

Article in Clinica by Amanda Maxwell

Overworked Notified Bodies Turn Clients Away And Demand Own 5-Yr Transition http://www.clinica.co.uk          View PDF    

By |November 4th, 2015|news|0 Comments

Negotiations

between the European Parliament on the future legislation are currently taking place. In this context, TEAM-NB, wishes to highlight several points still to be discussed between the Parliament and the Council. Enclosed our Position Paper on this negotiations.    

By |September 4th, 2015|news|0 Comments

IMDRF meeting

held by Commission on August 26th : 3 Team-NB representatives were present.      

By |August 30th, 2015|news|0 Comments

Scrip Regulatory Affairs “Two EU notified bodies join international pilot to test common submission format for devices”

2 Notified bodies joined a pilot program that is being run by the International Medical Device Regulators Forum to test a common electronic submission format for reviewing device submissions.        

By |August 8th, 2015|Uncategorised|0 Comments

Clinica “EU notified body numbers still yet to bottom out “

NB withdrawals are due to three reasons, she said: not being able to conform to new regulations; following a joint assessment or competent authority audit; and/or mergers of NBs.      

By |August 8th, 2015|news|0 Comments

Clinica “TÜV Rheinland’s legal woes over PIP will strengthen NBs sector

     

By |August 8th, 2015|news|0 Comments