GSM, Bluetooth, Wi-Fi and the rest – wireless communication technologies enable miniature medical devices to be built, making their use for medical purposes more comfortable, efficient and cost-effective. To ensure these technologies are safe, manufacturers of medical devices with radiofrequency wireless technology need to take the Medical Device Directives and the European Directive on Radio Equipment into consideration. After 13 years, the European Directive on Radio and Telecommunications Terminal Equipment (R&TTE, 1999/5/EC) will be repealed on June 13, 2016 and replaced by the new Radio Equipment Directive (RED, 2014/53/EU). TÜV SÜD Product Service has summarized the new requirements in its E-ssentials newsletter and presents the new RED in a PDF and ton his Internet page.
Key changes for manufacturers at a glance
Interoperability of accessories throughout the EU, e.g. use of standardized chargers.
Telecommunications terminal equipment is excluded from the scope of the RED. It is included in the scope of the Electromagnetic Compatibility (EMC) Directive 2004/108/EC and the Low Voltage Directive 2014/35/EU.
All economic operators must ensure the traceability of radio equipment along the supply chain.
In the future, radio equipment integrated into medical devices can be accompanied by a simplified Declaration of Conformity (DoC), provided the DoC includes a link to the exact Internet address where the full text of the EU declaration of conformity can be obtained.
The Directive introduces specific requirements for the language of manufacturer contact details, instructions, and safety information.
In the future, safety tests will have to include conditions of use that can be reasonably foreseen, including reasonably foreseeable misuse.
In the future, manufacturers will be responsible for investigating complaints of nonconforming radio equipment as well as for radio equipment recalls and keeping distributors informed of any such monitoring.
Importers or distributors who place radio equipment on the market under their names or trademarks will be subject to the same obligations as manufacturers in the future.
The RED was adopted by the European Parliament on April 16, 2014 and will come into effect on June 13, 2016. A transition period applies to June 13, 2017.