Per March 2010, the new modified Medical Device Directive becomes mandatory and there are several changes that needs to be prepared before March 2010. The major changes are:
1. Records must be retained for >5 years
Records must now be maintained for inspection by the Competent Authorities for the useful life of the product or 5 years from date of manufacture, whichever is greater. For implantable devices, records need to be kept for 15 years from the time the last product was manufactured.
2. Outsourced design and manufacturing must be more closely monitored
If the design or manufacturing of a device is done by a third party, you must demonstrate that you have adequate controls in place to ensure the continued efficient operation of the supplier's quality system.
3. Closer inspection of design documentation
Notified Bodies will be required to perform an inspection of design documentation for a representative sample of devices using industry standard statistical techniques and commensurate with the risk of the device.
4. Appointment of an Authorized Representative (AR) explicitly noted
The AR gets a mandate to act, and be contacted, in lieu of the manufacturer in terms of meeting the obligations by the Directives for all classes of devices.
5. Clinical data now required for ALL devices, including Class I
The new Directive imposes more stringent requirements as to what constitutes "clinical evidence" and mandates stronger enforcement by authorities. The definition of "clinical data" is included and the Essential Requirements includes a requirement for Clinical Evaluation according to Annex X, which has been significantly amended. We highly recommend you review the changes to Annex X.
Class I Sterile and Measuring devices will have more flexibility to select a route to compliance as they will be given the option to select a full quality assurance conformity assessment module.
7. Software is now clearly defined as an active medical device
It does not matter whether the software is integral with the device or is a standalone product. Software validation will also be an Essential Requirement.
8. Custom devices now subject to post market surveillance
Custom devices will now require a post-market surveillance system that is reportable to Competent Authorities.
9. Instructions for Use (IFU) must now be revision controlled
Where appropriate, the new Directive states that the date of issue or latest revision of the IFU must be clearly indicated.
Devices that incorporate human tissue, blood or plasma will fall within the scope of Directive 2001/83/EC and be considered Class III.
This information was provided by: MediTech Strategic Consultants B.V. - EN Vaals, The Netherlands
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