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News and Views March 2017

New Medical Device Regulation (MDR) in Europe
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8. Medical Device Networking Meeting
Hanover, April 27, 2017




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Revised EU Website


The Commission allocated the medical devices sector previously located under DG Enterprise to DG Health & Consumers.  DG stands for Directorate General and is in essence the Department in the Commission responsible for certain aspects.  This is highly political and may affect medical devices manufacturers in the long run. With the change most certainly the fear is that the main focus now may be on different areas. The website now followed the structure as well. 

Please find all the necessary information concerning European Medical Devices regulation here:  http://ec.europa.eu/health/medical-devices/index_en.htm

The following important aspects should be monitored:

a) The recast of the directive is on the horizon.  We expect in the not too distant future a new draft of the directive. The MDD and the AIMDD most likely are being combined.  The IVD may or may not be part of the update.  In the context it needs to be noted that the IVD is also under revision as a stand alone document.  Please see here it the so called roadmap for the planned action: http://ec.europa.eu/governance/impact/planned_ia/docs/2008_sanco_081_medical_devices_en.pdf

b) MEDDEV Guidelines are still being updated due to the revision of the directive in 2007.  Please check here http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm whether any of your controlled external documents needs to be considered for the conformity assessment procedure you apply for your products. Recent updates include:

 

 

 

2.4 Classification of MD

MEDDEV 2.4/1 rev.9  [654 KB]

June 2010

 

 

2.7 Clinical investigation, clinical evaluation

 

 

 MEDDEV 2.7/3  [166 KB] Clinical investigations: serious adverse event reporting               

SAE reporting form  [87 KB]

December 2010

 MEDDEV 2.7/4  [180 KB] Guidelines on Clinical investigations: a guide for manufacturers and notified bodies

December 2010

 

 

 

c) As with the guidelines, the standards are also being updated.  Here is the link to the recent publication of standards in the official Journal of the European Union: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:242:0008:0038:EN:PDF. The official Journal may not be as convenient and therefore the Commission provides a website where the listing of standards of all New Approach Directives (directive providing for CE marking) can be found:  http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/

d) A very important area on the website is the Borderline and Classifications Issues section. Please follow this link: http://ec.europa.eu/health/medical-devices/documents/borderline/index_en.htm.

The group recently published a new revision of the Manual on borderline and classification in the Community Regulatory framework for medical devices.

Here is the direct link: http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf

There are a number of things to explore on the overall European Commission website.  We recommend to identify the relevant documents for your conformity assessment procedure and include them in to your quality system.  A procedure should be established to visit once in a while, the European website in order to check for any new relevant updates or new releases. 

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