New legislation on the technical safety inspection of programming devices
BIOTRONIK Schweiz AG would like to inform you about significant changes in legislation that have a direct impact on the use of your products. These changes affect in particular the Renamic and Renamic Neo programming devices, which are Class III medical devices (life-support systems).
What is new in law?
Based on MedDO Art. 71 and TPA Art. 49, users (doctors, cardiologists, hospitals, medical practices) and distributors of medical devices are obliged to check the programming devices for pacemakers and implantable defibrillators annually in compliance with the legal requirements and to document these measures accordingly. This documentation must be made available to the authorities on request.
From 1 January 2023, it will be mandatory in Switzerland to carry out a technical safety check (measurement of all legally prescribed standard values) on these devices.
What documents are required during the inspection?
In the case of inspections by Swissmedic or by officially authorised companies, written confirmation of the annual technical system inspection must be submitted. The responsibility for the maintenance of the technical system control and documentation lies with the user, not with BIOTRONIK Schweiz AG.
How can we support you?
BIOTRONIK offers you the option of having this service carried out on site by a measurement specialist.
Upon conclusion of a maintenance contract and after a technical safety check has been carried out, you will receive a written confirmation from us and thus the one-year warranty, which illustrates compliance with the legal requirements. We can also provide you with a replacement device within two working days in the event of unforeseen damage (e.g. breakage of the housing).
Register for the service using our online form or contact us if you have any questions at technical.services.ch@biotronik.com.
Can other devices also be checked?
Yes, we kindly ask you to register the desired checks of other BIOTRONIK devices in advance.
Can BIOTRONIK carry out a free check-up?
No, according to TPA Art. 55 (duty of integrity/anti-corruption article) this would be considered a pecuniary benefit and is therefore not legally permissible.
Are your own technicians allowed to carry out the inspection?
For purchased devices, yes. However, loaned devices remain the property of BIOTRONIK and require specialised checks.
What is the process?
- Registration via the online form
- Contract delivery
- Conclusion of contract
- Making an appointment
- Carrying out inspection
- Delivery of test reports