Essentially, this new Directive is the first significant modification to the Medical Device Directive since 1993 and there are several changes you may need to prepare for WELL BEFORE it becomes mandatory in March 2010. Here is a brief overview of major changes.
1. 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.
2. 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.
3. Class I (Sterile and Measuring) devices may now choose Annex II
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.
4. 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 quality system.
5. 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.
6. 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.
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.
10. Borderline products
Whether a product is classified as a medicinal product or device will now be determined by the Primary Mode of Action rather than by the Intended Use!
11. Definition of central circulatory system has been expanded
Now includes the vessels aortic arch (arcus aortae) and descending aorta (aorta descendens) to the aortic bifurcation (bifurcatio aortae). Any devices that come in contact with these vessels will now be considered Class III.
12. Definition of continuous use has been expanded
13. European databank
Data related to clinical investigations will now be collected for the European databank and shared among Competent Authorities. The databank will also include information on registration, Authorized Representative, certificates and vigilance data. The data must be submitted in a standardized format, yet to be determined. The Directive states that the databank must be operational by September 2012.
14. Human tissue
Devices that incorporate human tissue, blood or plasma will fall within the scope of Directive 2001/83/EC and be considered Class III.
The changes noted above mostly impact the Medical Device Directive. However, Directive 2007/47/EC also impacts the Active Implantable Medical Device Directive (90/385/EEC) which was adopted in 1990 before the MDD. Also, the new Directive clearly states that IVDs are specifically excluded from Directive 98/8/EC on Biocides, eliminating confusion as to which Directive apply.
Nina She