Course code RA2

Course " Medical Device Directive Compliance" with exam (2 days)

Course description:

This two-day comprehensive course provides participants with an in-depth understanding of the requirements of the EU Medical Device Directives and the CE Marking approach and focuses on the Medical Devices Directive (MDD) including active and non-active medical devices. It gives participants the latest information regarding the interpretation and enforcement of these Directives. Most importantly, it facilitates your company to put medical devices on the EU market (25 countries and still expanding) more quickly!

Subjects covered include: the Structure of the Medical Device Directives; the Definition of a medical device; the EU Classification System for medical devices; Combined medicinal/medical device products; the CE Marking Approach and the countries in which it is applicable; Conformity Route Assessments; the Role of Notified Bodies and Competent Authorities; Quality Assurance requirements for manufacturers of medical devices in the EU and the application of ISO 13485; Essential Requirements; the Role of Standards; Pre-clinical testing; Clinical investigations and evaluations; Shelf life studies; Labeling, Packaging and Sterilization; Risk assessment; Post Market Surveillance and Vigilance systems; Compiling a Technical File; and requirements for the “Declaration of Conformity”. Participants will also be directed in the use of Harmonized Standards and guidance documents such as the “MEDDEV” ( the guidelines relating to Medical Device Directives) and the “GHTF” (Global Harmonization Task Force) documents.

Participants will be informed about any changes to the MDD and about the likely consequences of such changes for their product. If required, the MDD can be examined in relation to other regulatory requirements, e.g. the FDA or CMDR regulations. For non-EU medical device manufacturers, the role of the “Authorized Representative” is explained.

Practical examples and case studies will be used extensively during the course.

At the end of the two days participants will be required to show that they have acquired the relevant know-how by taking a short exam.

Course objectives:

To provide participants with a comprehensive understanding of the requirements for developing and marketing medical devices in the EU, thus allowing them to progress their product to the market by the fastest route

• To inform participants about the latest, and forthcoming, requirements of the MDD and the consequences of any changes
• To demonstrate for participants the use of harmonized standards and guidance documents.
• If required, to compare for participants the MDD and other regulatory regimes such as the FDA or CMDR.

Who should attend:

There are no prerequisites for this course, but a basic understanding of medical devices, quality assurance and recognized standards would be helpful. The course is aimed at:

• Medical Device Companies new to the EU Market
• QA/RA Managers with responsibility for CE Marking Audits
• Project Managers
• R&D Personnel
• Clinical Research Personnel

Course materials:

Participants will receive a comprehensive course manual with reference materials, and upon successful completion of the course and the exam, a “certificate of attendance and satisfactory completion”.

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