Medical Devices – EU Directives Guidance CE Marking and ISO Standard Certifications

The European Union (EU) provides an attractive marketplace for medical device distribution. Development of requirements harmonized across the 27 member states should make it a straightforward process to get products approved in each country - but is it? This course works through the requirements for medical devices, the steps to obtain entry into the marketplace (including setting up a number of on-going procedures and relationships), and shares some lessons learned from the Course Director, who has over 20 years of experience with CE marking medical devices for distribution in the EU.
The course will introduce the Medical Device Directives (AIMD, MDD & IVDMDD), the meaning of the CE symbol and how & when to legitimately apply this mandatory mark of conformity, the significance of Notified Bodies, Competent Authorities, and Authorized Representatives. Additionally, the significance of the QMS, ISO 13485 and ISO 14971, and reference to ISO 14000 will be explained as necessary elements in addressing the essential requirements, technical dossiers, declarations of conformity and the six steps required for manufacturers to market medical devices in the European market.
Throughout the course, examples and case studies will help participants apply the concepts being covered.