Medical Device Directive (2007/47/EC)
D.L.S. Conformity Assessment understands your product and the requirements that you must comply with – from risk assessment and essential performance requirements to the completed Medical Device Directive 2007/47/EC (MDD) certification process.
Since the third edition of IEC 60601-1 takes effect later this year, D.L.S. CA can help you to meet that deadline. The third edition of IEC 60601-1, as compared to the second edition, presents a monumental change in approach to the testing of medical devices. This standard places a lot of attention on the risk management – ISO 14971 and essential performance of the equipment. Because of the lack of uniformity between the European Union, USA and Canada at this time, both standards are still used today. For the medical device manufacturers, it is often hard to decide which version of the standard is the one they should use. Most of the people in the industry are opting for both versions of IEC 60601-1 to satisfy the requirements.
According to the language of MDD, medical devices are defined as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
The main focus of the Medical Device Directive is to:
- define the essential requirements that medical devices must meet before being placed on the market
- establish conformity assessment procedures based on device classifications
- create tracking and reporting mechanisms available to national authorities to ensure and protect public health
As part of the total MDD package from D.L.S. CA you will receive a detailed analysis of your risk assessment, quality system (ISO 13485) and technical file.
When it is determined that your product meets all the requirements of the Medical Device Directive, you will be able to put the CE Mark on your device and start selling in the European Union Economic Area.
D.L.S. Conformity Assessment can also address all your North American compliance needs for the upcoming revision of UL 60601, taking effect in summer of 2013.
For more information, please contact Mitch Gaudyn at 847-537-6400 or request a quote online through the sidebar on the right.
