UTC News

Date ArticleType
9/20/2011 Past Breakfasts/Lunches
Update on European Regulatory Affairs

Dr. Michael Rinch, CEO of ‘MT Promedt Consulting’ Germany spoke about updates on medical device directives.  Dr. Rinch covered five main points:  changes and trends in European medical device regulations, changes of directive 2007/47/EC, European registration requirements, revision of RoHS directive and upcoming changes in IVD Directive 98/79/EC. 

He pointed out that the European Union is comprised of more than 490 million people, made up of 29 different member states, each having different cultures.  Twenty-one different languages are spoken between the different member states.  Croatia will join the EU in July of 2013.

Changes to directive 2007/47/EC, which was implemented in March of 2010, will affect classification/reclassification, conformity assessment procedures, essential requirements, European authorized representative and clinical evaluations.

Click here to view the guidance document for the classification of medical devices under MEDDEV 2.41/1 rev.09 June 2010.

Click here to view the manual on borderline and classification in the community regulatory framework for medical devices version 1.10 (08-2011) (NEW)

Dr. Rinch reminded those in the industry to watch for the major changes in MDD that will impact manufacturers, control your CE compliance by regular Standard Evaluations, understand the auditing process by notified bodies, the regulatory system of IVD directive will be adapted, know the upcoming changes to the RoHS directive and understand CE marking requirements and marketing requirements.

Please click below to listen to audio and to review Dr. Rinch’s Power Point presentation.

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