MTANZ

Select Relevant Account

Select yourself to see only your informmation.
Select an organisation to manage it as well.

Login





Forgot password?
Create an Account

Regulatory & Policy

News COMMISSION RECOMMENDATION
01 Sep 2013
News US FDA Updates Plans for UDI and Post-Market Surveillance System
05 Apr 2013
News IMDRF Recommendations for UDI Systems
01 Apr 2013
News Europe's Proposed Medical Device Regulation
01 Mar 2013
News eIFU from 1st March 2-13 - European Commission Regulation (EU) No 207/2012
01 Feb 2013
News Scientific Disagreements Regarding Medical Device Regulatory Decisions
01 Jun 2012
News Factors to consider when making benefit-risks determinations in Medical Device Pre-market approval and De Novo classifications
01 Mar 2012
News New Borderline & Classification Medical Device document
09 Apr 2012
News MEDDEV 2.1/3 Rev3
08 Apr 2012
News MEDDEV 2.12-1 Rev6
07 Apr 2012
News Medical Device Directive
06 Apr 2012
News Medical Device Directive
05 Apr 2012
News Medical Device Directive
05 Apr 2012
PagePage1
 
New Borderline & Classification Medical Device document 09 Apr 2012

Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Or alternatively, borderline cases are those cases where the product falls within the definition of a medical device but is excluded from the Directives by their scope. Where a given product does not fall within the definition of medical device or is excluded by the scope of the Directives, other Community and/or national legislation may be applicable.

Read document

TOP

©copyright Medical Technology Association of New Zealand, all rights reserved. Privacy Policy and Disclaimer.

Powered by streamSWEET CMS