Along with amending the MDD, 2007/47/EC also brings changes to the Implantable Medical Device Directive and these enter into effect on the same date. The changes, this amendment directive leads to, are rather complex and will probably have an influence on all medical device manufacturers.
The revision leads to some changes to technical and design files, which will have to be updated to include clinical data for all products. Ergonomic requirements of devices are based on new standards and become stricter in order to decrease the risk of usage errors. Directive 2007/47/EC does not approve the use of Phthalates in medical devices and requires their clear labelling if they are found in certain types of device. It further includes requirements that cover the entire lifecycle of medical software and it extends the retention of implanted devices records to 15 years.
Change affecting various Products
Furthermore, all medical devices that are also personal protective equipment (PPE) should comply, as from 21 March 2010, to the essential requirements of both the Medical Device Directive 93/42/EEC (http://www.medicaldevices.sgs.com/europe-directive9342-eec.htm) as amended by 2007/47/EC and Personal Protective Equipment Directive 89/686/EEC. This is similar for Medical Devices which are also Machines as defined in the Machinery Directive 2006/42/EC.
To help medical devices manufacturers with the implementation of the new MDD requirements, SGS offers both public and in-house training to all interested companies.
You must be logged in to post a comment Login