Amendments in Medical Devices Directive
As of March 21, 2010 all medical devices distributed in the EU must abide by Directive 2007/47/EC which is amending 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.
(firmenpresse) - 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.
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 59,000 employees, SGS operates a network of over 1,000 offices and laboratories around the world.
Contact information:
SGS Electrical and Electronics
Susanna Serra
CTS E&E Director
+34 628 31 17 95
ee.global.marketing(at)sgs.com
www.sgs.com/ee
Datum: 10.03.2010 - 08:06 Uhr
Sprache: Deutsch
News-ID 1011163
Anzahl Zeichen: 0
contact information:
Contact person: Susanna Serra
Town:
Phone: +34 628 31 17 95
Kategorie:
Electronics & Semiconductors
Anmerkungen:
Diese Pressemitteilung wurde bisher 157 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Amendments in Medical Devices Directive
"
steht unter der journalistisch-redaktionellen Verantwortung von
SGS Electrical and Electronics (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
