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News and Views April 2012

1. Updates of guidelines and new release of the guideline for Authorized Representative

                a) Vigilance guideline and forms

                b) Post market clinical follow up

                c) Guideline for Authorised Representatives

                d) Reference to new or updated Guidelines



1. Updates of guidelines and new release of the guideline for Authorized Representative

The European Commission is updating its guidance documents and other related documents in order to provide a common understanding of the Directive(s) but also changes the interpretation due to experience and as such regulatory requirements develop over time.  These clarifications of the requirements may also be part of any new upcoming regulation.  In addition, due to the last update of the directive (2007) documents are still being revised.



a)     MEDDEV 2.12/rev7: Medical Devices Vigilance System (March 2012)

MDSS Comment:  The vigilance guideline was updated and the major aspects are the inclusion of two new forms: Manufacturer’s Summary Reporting and Manufacturer’s Trend Report Form. 

The summary and trend reporting were foreseen in the guideline before, but without any tools and therefore not very much used by manufacturers. 

In particular the trend reporting provides for a formal tool to involve the authority early on any negative trend a manufacturer may become aware of.  It may in particular be useful for diagnostic products.  With the forms available the authority now expects more reporting with these forms. 

The Guideline sets a due date for June 15, 2012.  MDSS offers a review program for its clients to ensure that the requirements are implemented.  Please contact us for further details.

 

b)      MDDEV 2.12/2 rev. 2: Post Market Clinical Follow-Up Studies (January 2012)

MDSS Comment:  This guideline is result of the Directive Update in 2007.  Now with its second revision it clarifies a number of aspects in regards to the clinical studies after a product has been CE marked.  It is also a guideline for the notified body.  



c)       MEDDEV 2.5/10: Guideline For Authorised Representatives

MDSS Comment:  The guideline for the AR was overdue.  It outlines nicely the requirements of each medical devices directive.  With that subtle differences between them are apparent but it clarifies in essence that the same rules should apply.  Clarification is given in regards to the responsibilities of the manufacturer and the AR and that a written agreement should be established to outline specific tasks. 

The evaluation of our current contract revealed that we are in compliance with the guideline.  However, we will update the contract in the near future to reflect the exact wording of the guideline in relation to the expected responsibility of the manufacturer and the AR. 



d)      Other new or updated Guideline

MEDDEV 2.1/6: GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES (New: January 2012)

MEDDEV 2.2/4: Guidelines for conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products (New: January 2012)

MEDDEV 2.14/1 rev.2: IVD Medical Device Borderline and Classification issues (January 2012)

MEDDEV 2.14/4 GUIDELINES RELATING TO THE APPLICATION OF:

Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (New: January 2012)





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