A new Regulation (EU 207/2012) on electronic instructions for use of medical devices has been recently adopted by the European Commission and it will come into full force starting 1st of March 2013.
Apart from the CE marking affix requirements and the designation of a European Authorized Representative (EAR) for all non-EU manufactures of medical devices underlined by the MDD 93/42/EEC and AIMDD 90/385/EEC, the new Regulations brings several instructions for manufacturers on how to make available the electronic labels of products.
The European Commission has recently published a new Regulation (EU 207/2012) on electronic instructions for use of medical devices which shall be applicable starting 1st of March 2013.
The new Regulation consists of instructions for manufacturers of medical devices that may provide electronic labels of products made available for patients and professional users.
This new document is meant to reduce potential risks as much as possible and to ensure customers have unconditional access to see the instructions for use of medical devices.
Thus, the manufacturer shall make available the electronic information on its website maintaining the mandatory elements described in point 15 of Annex 1 to Directive 90/385/EEC and in point 13 of Annex I to Directive 93/42/EEC, in the following cases:
- Active implantable medical devices, as covered by the AIMDD 90/385/EEC Directive
- Implantable medical devices and fixed installed medical devices, under the Medical Device Directive (MDD 93/42/EEC)
- Medical devices and their accessories fitted with built-in system visually displaying the instructions for use, under both AIMDD 90/385/EEC and MDD 93/42/EEC
- Stand-alone software covered by MDD 93/42/EEC
As indicated in the new Regulation, the manufacturer should also clearly indicate on the packaging of the device how to access the instructions for use in electronic form.
Further, the packaging must also contain the CE marking affix which allows medical devices to freely circulate in the European Market. For non-EU manufacturers interested in exporting their products to the EU, designating a European Authorized Representative (EAR) is also compulsory under European law.
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