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A FAQ for medical equipment with intentional radios

posted May 31, 2016, 9:19 AM by Frank O'Brien

Some terms:


Term

Meaning

Intentional radio

radio transmitter such as for WiFI, Bluetooth, RFID, cell phones

R&TTED

Radio and Telecommunication Terminal Equipment Directive, 1999/5/EC

RED

Radio Equipment Directive,  2014/53/EU

MDD

Medical Device Directive, 93/42/EEC


Harmonized standards for RED and R&TTED, http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/rtte/index_en.htm


Q1. What’s the effective date for RED?


A1: On 13 Jun 2017, all electrical medical equipment with intentional radios placed on EU market will need to comply with RED, (except radios that fall within the exceptions listed in Annex I: amateur, marine, airborne, R&D).  The R&TTED will be no longer valid.


Q2: Can a new electrical medical device with an intentional radio be placed on the market in compliance with R&TTED up until 13 Jun 2017?


A2: Yes.  It probably wasn’t the intention for new equipment, as the R&TTE is repealed on 13 Jun 2016, but the period between 13 Jun 2016 and the 13 Jun 2017 effective date for the RED is being treated as a transition period for new and legacy equipment being placed on market.


Q3: Does RED take full responsibility for the medical device?


A3: No, the medical device will still need to comply with the MDD and its harmonized standards, including the safety standard series EN/IEC 60601/ISO 80601, its EMC collateral, EN/IEC 60601-1-2, and the reference standards to which the collateral refers, including, series EN/IEC 61000-x-x.


The radio portion will need to comply with the RED and its harmonized standards, including  EN 300 328-x and the EN 301 489-x standards.


Q4: What’s listed on the Declaration of Conformity (DoC)?


A4: The DoC must declare conformity to both the MDD, and RED.  The MDD DoC does not require harmonized standards be listed on the DoC (rather these are in technical file).  Article 18, and Annex VI of RED requires that the “harmonized standards, or other technical specifications” be part of DoC.


Q5: Has an analysis been done to summarize the worst case radio/EMC standards to which medical devices with intentional radios need to comply?


A5: No.  An analysis will need to be done on a case by case basis.  In the case of a radio module certified and tested, all the work with respect to the RED directive has been already done. The compatibility of the module with the medical part is then evaluated with the safety tests, EMC tests, etc. for the whole combination, for example by application of the EMC standards listed as harmonized standards under the MDD.


Q6: Can OBCM help with further questions?


A6: Yes.


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