The Polish comments on new regulation concerning electronic instruction for use of medical devices Aleksandra Rodatus-Gil Department of Medical Devices Surveillance, Vigilance and Clinical Trials

The scope of regulation Article 3 point 1: Manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices: active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device; implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device; fixed installed medical devices covered by Directive 93/42/EEC; medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use; stand alone software covered by Directive 93/42/EEC.

The scope of regulation respirators operating table dialysis devices cryotherapy devices aspirators e-IFU e-IFU

Access to IFU Article 2 point b: "instructions for use in electronic form" means instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or instructions for use available through a website; Article 5 point 9: for devices with a defined expiry date, except implantable devices, they shall keep the instructions for use available for the users in electronic form for at least two years after the end of the expiry date of the last produced device; Article 5 point 10: for devices without a defined expiry date and for implantable devices, they shall keep the instructions for use available for the users in electronic form for a period of fifteen years after the last device has been manufactured.

Access to IFU e-IFU Manufacturer Device Only on the website production sale end of activity delivery and sale (distributor) delivery and sale (distributor) delivery and instalation Time Sale End of activity = end of the website Delivery

New regulation costs Recitals point 1: For some medical devices the provision of instructions for use in electronic form instead of in paper form can be beneficial for professional users. It can reduce the environmental burden and improve the competitiveness of the medical devices industry by reducing costs, while maintaining or improving the level of safety. Article 5 point 3: they (manufacturers) shall have a system in place to provide the instructions for use in printed paper form at no additional cost for the user, within the time period set out in the risk assessment referred to in Article 4 and at the latest within seven calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order;

New regulation costs Before regulation manufacturer pays for: Printing of the paper IFU delivered with the device After regulation manufacturer pays for: Maintenance of the website even thought e-IFU is delivered with the device in portable electronic storage media Maintenance of the special service department for collecting the orders for paper IFU Printing of the paper IFU Hight cost of express parcel or branches in every country where devices are on the market

New regulation costs If the user needs the paper IFU why he can’t print IFU instead of asking the manufacturer – faster and easier! The duty of the paper IFU delivery on the request may be replace with the requirement of providing printed-friendly version of e-IFU

The differences between countries Article 5 point 2 „they (manufacturers) shall provide instructions for use in electronic form in all Member States where the product is made available or put into service, unless duly justified in the risk assessment referred to in Article 4” Cost of delivery in Poland Cost of delivery from Poland to Spain

Patient instruction for use Article 6 point 4 „Where a part of the instructions for use is intended to be provided to the patient, that part shall not be provided in electronic form.” Part for patient has to be rub out from e-IFU for professional user The part of IFU for patient can not be deliver in paper and in electronic form at the same time Is the delivery of the paper-IFU and e-IFU of the device intended for lie-person in accordance with this regulation?

A lot of manufacturers are small and average companies! For the future To extend the regulation scope - all medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively by professional users To reduce costs of the regulation – remove the duty of the paper IFU delivery on the request and maintenance of the website if the e-IFU is delivered with the device A lot of manufacturers are small and average companies! To solve problem of access to IFU if manufacturer had finished their activity

Thank you for your attention