;   Medical Translation Insight: Notified Bodies getting aligned with proposed EU medical device regulations - ForeignExchange Translations

Notified Bodies aligning with  medical device regulations - medical translation
Our friend Leo Eisner forwarded this item to us, noting that it represents a quite significant step towards aligning with the proposed EU Regulations to come not that long from now (in about 2 years).
"On 10 Oct 2012 The European Association for Medical devices of Notified Bodies (better known as Team-NB) issued a press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies under Directives 90/385/EEC (Active Implantable Medical Devices Directive), 93/42/EEC (Medical Devices Directive), and 98/79/EC (In-Vitro Diagnostic Directive) that is focusing on the recently proposed Medical Device Regulations."
Apparently, the major topics covered are:
  1. Implementation, enforcement and monitoring of the Code of Conduct
  2. Qualification and Assignment of Notified Body Assessment Personnel
  3. Minimum time for Notified Body assessments
  4. Unannounced visits
  5. Sampling of class IIa and IIb technical files
  6. Design Dossier Reviews
  7. Rules for subcontracting
  8. Rules for Certification Decisions
For the more details, head to Eisner Safety's blog and the Team-NB press release [PDF link].

ForeignExchange Translations provides specialized medical translation solutions for regulatory affairs, clinical research, marketing, and training groups at medical device and diagnostics companies.


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