Obelis European Authorized Representative Center"CE Marking Consultants with a Reputation for Excellence"
As you may know the 2007/47/EC amended the MDD 93/42/EEC which may have an immediate impact on the compliance of your medical devices in Europe.
There are two main amendments that are particularly important.
1. A decreasing of the importance of the Medical Device Directive 93/42/EEC in respect to all other European Directives.
2. The influence of the Machinery Safety Directive on the MDD 93/42/EEC (medical devices with moving parts), which will result in the combination of essential requirements in regards to both Directives.
• Both of which will be in full force by March 21st, 2010.
Obelis has created a CD presenting the following valuable guidelines:
• A table of essential requirements for MDD and MSD, written by Dr. Peter N. Ruys, one of the initial officials to implement the Medical Device Directive in Europe.
• A consolidated version of the Directives MDD 93/42/EEC with the amendments from Directive 2007/47/EC
• A Consolidated table of Essential Requirements of the MDD 93/42/EEC & the 2007/47/EC – NEW!
• The MSD 2006/42/EC
• A list of the European Standards under EU Machinery regulation
We are confident this CD will assist you in your understanding of the implementation of these new amendments.
You can order this CD by emailing us at .
As an Obelis client you may purchase the CD at a discounted rate of €150.00(euro).
Do not hesitate to contact us with any questions or concerns.
Contact us now to find out more.