HS1 and FRx have successfully completed MDR Technical Documentation Assessment

Why is Heartstream sharing this update?
We have recently received questions from partners regarding the MDR status of the Heartstream AED portfolio. This bulletin summarizes the clear guidance on how to communicate with your customers.

Key Messages
HS1 and FRx have successfully completed MDR Technical Documentation Assessment and Certificates have been issued. Although the HeartStart HS1 and HeartStart FRx defibrillators have received MDR certification, the products currently supplied to the EU market, manufactured by Philips Medical Systems, will continue to carry MDD labeling due to needed labeling updates. This is a planned transition associated with the separation of Heartstream from Philips and does not affect the regulatory status or the availability of the products.

Note: HS1/FRX AEDs and accessories manufactured by Heartstream US LLC will continue to be brandedas Philips under a licensing agreement.

Why are products still labeled under MDD
The current Philips-branded AEDs continue to be supplied under the MDR transitional provisions while maintaining full regulatory compliance. Rather than updating Philips labeling, Heartstream will introduce MDR-compliant labeling with the future Heartstream-manufactured Philips AEDs planned for release in 2027. The current AEDs, manufactured by Philips Medical Systems will continue to be supplied under the MDR transitional provisions while maintaining full regulatory compliance.

Rather than updating labeling for AEDs manufactured by Philips Medical Systems,AEDs manufactured by Heartstream US LLC will introduce MDR-compliant labeling AEDs.  This is planned for release in 2027.

What about batteries and pads?
The following accessories manufactured by Philips Medical Systems,are already on the EU market as MDR compliant.

• HeartStart Battery
• HeartStart Adult SMART Pads Cartridge
• HeartStart Infant/Child SMART Pads Cartridge
• HeartStart SMART Pads II
• Infant/Child Key

Apart from the Class IIb HeartStart Infant/Child Pads Cartridge, all other Class I medical devices. Under the MDR framework, Class I devices are self-certified by the manufacturer and do not receive individual MDR certificates.
Compliance is demonstrated through the Declaration of Conformity (DoC) together with our certified Quality Management System.

Does this affect customers?
No.  There is no impact on product quality, safety,performance or availability.
Products, manufactured by Philips Medical Systems, continue to meet all applicable regulatory requirements for placement on the European market.

Supporting Documentation
Upon request, the following documents can be provided by us.

• MDR Quality Management System Certificate
• Declaration of Conformity (where applicable)
• Additional regulatory documentation