Sent: Tuesday, April 29, 2003 12:49 AM
To: Haubrich, Greg; [email protected]
Cc: Ivans, Veronica; Resch, Gerda; den Besten, Kees; Poutsma, Auke; Roelofs-Heyrmans, Maarten; Wilke Dr., Joachim; Kaiser, Bernd
Subject: yesterday's RAE meeting
All,
Here's a list of the relevant radio regulatory topics that were discussed during yesterday's meeting to my understanding:
1. User documentation: Since we don't adequately warn users of our devices by listing the countries we're not meeting the requirements of the RTTE. Cyriel believes that since our products are not sold on the shelves of stores that it's very unlikely our product non-conformance will be noticed. Veronica stated that a decision was made at an upper management level that we would rather pay a fine than change the documentation since that will take a year. If we are found in non-conformance our products will be forced off the market until we add a sticker or other documentation to our product with detailed country information.
2. Notified body number. Medtronic RAE in Europe is self-notifying which is why there is no notified body number on our submissions. Vitatron is using Kema.
3. The involvement of Neuro, Mini-Med, and Vitatron was requested for any radio standards activities besides the usual suspects. Gerda Resch was mentioned as the Mini-Med contact and Kees den Besten will determine who should be involved from Vitatron.
4. We discussed the possibility of bad publicity for Medtronic if news that the Annex 12 has not yet been fully adopted is leaked. Cyriel recommended discussing this issue with his contacts at the CEPT and European Commission at the next SRD MG. The group seemed generally positive to this recommendation.
5. Some SMA responses to our notification submissions have asked for a response from Medtronic. Some responses have stated that we need a license. Cyriel informed us that these requests are not acceptable according to the RTTE directive and that the issuing agent at the national authority was uninformed about the requirements. Concern was expressed that Medtronic will appear to be arrogant if it does not respond. Cyriel recommended and will be tasked to communicate with contacts at the European Commission to ensure SMA responses are in line with the requirements of the RTTE. Guidant obtaining regulatory relief from Spain for one of the responses to their notifications was discussed. Without knowing more about how Guidant obtained relief it's difficult to know whether their approach to holding a meeting in Spain would be more effective as compared to an informal discussion by Cyriel to ensure the radio regulatory authorities follow the RTTE directive.
6. I mentioned an EMC/EMI standardization activity for hospital equipment manufacturers involving several companies and various government agencies has begun and that Medtronic has been requested to participate as an implant manufacturer. There didn't seem to be much interest in this activity.
7. Potential Eucomed activities were discussed. We discussed concerns that should Eucomed become involved in working to accelerate the adoption of ERC REC Annex 12 that it should be coordinated with Cyriel since he has acted as the industry representative in the past. We must be sure that Eucomed activities are consistent with past activities. We discussed the possibility that Eucomed may take action against Medtronic's wishes or that our competitors may try to obtain additional information about Medtronic internal activities by involving Eucomed in the process but those familiar with Eucomed do not believe either would occur. Cyriel strongly recommended the national authorities not be approached directly as there may be a backlash against the medical device industry or bad publicity.
8. Cyriel recommended he communicate informally with contacts he has within the European Commission, that he write letters to countries which have replied that they are in the process of implementing Annex 12B in order to accelerate the adoption process.
9. Tetra issues were discussed. No devices are known to have a problem though Thera is suspected to be susceptible. We have yet to obtain FDMA Tetra radios for testing which are expected to provide worse interference compared to the TDMA models we currently use.
10. Status of Telemetry C (i.e. MICS) was discussed including:
a. Decision status ERC/DEC (01)17
b. Only Sweden and Greece have yet to adopt though both are expected to eventually
c. No action should be taken against Biotronik MICS in Europe at this time
d. The 2090C programmer is FCC approved in the U.S. Phil Ingliss has started the process of getting it approved in Europe though time constraints have slowed progress.
e. Threats to the MICS band: Lucent's CDMA system, Fraunhoffer institutes interest in using MICS band for out of body communication networks, Norway is asking for spectrum that may eventually result in a request to open up the MICS band to undesirable emitters.
11. We discussed RAE leading the low frequency telemetry standards activities. There was general agreement that this is a good idea.
12. EMC standard 489-3 and -1 were discussed. We will attempt to have the AIMD test requirments apply to meet the RTTE EMC/EMI requirements. Veronica mentioned that she believes we would have been able to meet our requirements under the RTTE directive much easier and at a lower cost if we had taken a different approach in the past. I am unclear on the alternative approach that could have been taken.
13. Recommended activities for Cyriel for the coming year:
RAE support:
a. Monitor activities in CEPT, TCAM, SRD MG, ETSI, at the national levels and everywhere else appropriate. Provide periodic progress reports.
b. Provide copies of documents from working group activities
c. Provide advice and recommendations for working with SMA's. Work to ensure SMA's follow the RTTE directive.
d. Provide training and update meetings quarterly
e. Under Medtronic guidance manage standardization process for EN 302-195, and EMC/EMI standards support. Report on each meeting as required.
f. Communicate directly with RAE regarding all radio regulatory issues
g. Provide progress reports on standards and other activities monthly.
h. Lobby for exemption from blocking requirements of 300 330
i. Initiate process in Chinca for telemetry A/B acceptability (Chris Fuller recommendation since Cyriel will be in China and may be able to complete this activity while working on another contract.)
Telem C support
h. Champion the EN 300 489-27 standard
i. Continue working towards full adoption of Annex 12 once all countries are adopted.
j. Work to address threats to MICS band in Europe
k. Work to help Medtronic obtain regulatory approval for our 2090C and D1C in Europe
Please let me know if I missed anything. I'll clean up the language and add a few more items to Cyriels official statement of work over the next day or so.
Best regards,
Chris