From March 21, 2010 all medical devices distributed in the EU must comply with Directive 2007/47/EC which is an amendment to the Medical Devices Directive (MDD) 93/42/EEC. After this date, manufacturers who CE mark their devices under directive 93/42/EEC must also comply with 2007/47/EC.
Besides amending the MDD, 2007/47/EC also brings changes to the Implantable Medical Device Directive and these become effective on the same date. The changes this amended directive brings about are rather complex and will probably affect all medical device manufacturers.
The revision brings 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 the new standards which have become more stringent to reduce the risk of usage errors. Directive 2007/47/EC does not endorse the use of Phthalates in medical devices and requires their clear labeling 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 device records to 15 years.
Changes Affecting Various Products Furthermore, from 21 March, 2010, all medical devices that are also Personal Protective Equipment (PPE) should comply with the essential requirements of both the Medical Device Directive 93/42/EEC 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 device manufacturers with the implementation of the new MDD requirements, SGS offers both public and in-house training to all interested companies.
To access the audio recording of the SGS webinar on 2007/47/EC, visit: Medical Device website.
For answers to queries about the Medical Device Directive please email E&E Services.
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