CD of Essential Requirements for MDD & MSD
As a foundation for the implementation of the expected amendments within European Directives, Obelis has created a CD containing valuable information which will assist in the implementation of these Directives.
An important change in the European Directive is the influence of the essential requirements of the MSD 98/37/EC and its amendment the 2006/42/EC on the MDD 93/42/EEC and its amendment the 2007/47/EC.
The transposition period for these changes:
• Began December 21st, 2008
• Will be in full force March 21st, 2010
1. Complying with the essential requirements of both the MDD and MSD does not mean a 2nd CE Marking for your product. Regardless, concluding the process of identification of proper regulation and product classification is a must!
2. A Medical Device which has any form of moving parts will need to comply with both the MDD and MSD essential requirements.
3. Technical Documentation needs to be revised and certified no later than March 21st, 2010.
Steps for implementation:
1. Analyze if machinery directive is applicable
2. Analyze the essential requirements by comparing them with the ER of the IVDD or MDD and the existing risk analysis
3. Check if there are additional requirements for your product
4. Analyze if harmonized standards exist to cover the open ER’s
5. Redesign the device making use of standards
6. Find a test house to test compliance with the standard
This CD presents the following useful guidelines:
1. A table of essential requirements for MDD and MSD. This table was written by Dr. Peter Ruys, one of the initials writers of the European Medical Device Directive and Regulatory Advisor for Obelis s.a. It contains the essential requirements for the MDD 93/42/EEC as well as for the MSD 2006/42/EC. The table shows the corresponding elements between these two Directives in risk analysis, the standards used, and the results.
2. A consolidated version of the MDD 93/42/EEC with the amendments from Directive 2007/47/EC. This file demonstrates the Directive and explains the amendments
3. The MSD 2006/42/EC. The full Directive
4. A list of the European Standards under EU Machinery regulation. Lists the reference, title, cessation and more of each of the European standards under Directive 98/37/EC on Machinery
We are confident this CD will assist in your understanding of the implementation of these new amendments.
If you would like to order this CD, please contact Mr. Doram Elkayam at firstname.lastname@example.org .