(1)

‘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 made available through a software or a website;

(2)

‘professional users’ means persons using the device in the course of their work in the framework of a professional healthcare activity;

(3)

‘fixed installed medical devices’ means devices which are intended to be installed, fastened or otherwise secured at a specific location in a health institution so that they cannot be moved from this location or detached without using tools or apparatus, and which are not specifically intended to be used within a mobile healthcare institution.

(a)

knowledge and experience of the intended users in particular regarding the use of the device and user needs;

(b)

characteristics of the environment in which the device will be used;

(c)

knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form;

(d)

access of the user to the reasonably foreseeable electronic resources needed at the time of use;

(e)

performance of safeguards to ensure that the electronic data and content are protected from tampering;

(f)

safety and back-up mechanisms in the event of a hardware or software fault, particularly if the instructions for use in electronic form are integrated within the device;

(g)

foreseeable medical emergency situations requiring the provision of information in paper form;

(h)

impact caused by the temporary unavailability of the specific website or of the internet in general, or of their access in the healthcare institution as well as the safety measures available to cope with such a situation;

(i)

evaluation of the period within which the instructions for use shall be provided in paper form at the user’s request;

(j)

assessment of the website’s compatibility displaying the electronic instructions for use with different devices which could be used to display those instructions;

(k)

management of different versions of the instructions for use, where applicable in accordance with Article 5(8).

(1)

the risk assessment referred to in Article 4 shall demonstrate that providing instructions for use in electronic form maintains or improves the level of safety obtained by providing the instructions for use in paper form;

(2)

they 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;

(3)

they shall have a system in place to provide the instructions for use in 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 7 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;

(4)

they shall provide, on the device or a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device;

(5)

they shall ensure the proper design and functioning of the instructions for use in electronic form and provide verification and validation evidence to this effect;

(6)

for devices fitted with a built-in system visually displaying the instructions for use, they shall ensure that displaying the instructions for use does not impede the safe use of the device, in particular, life-monitoring or life-supporting functions;

(7)

they shall provide, in their catalogue or other appropriate device information support, information on software and hardware requirements needed to display the instructions for use;

(8)

they shall have a system in place to clearly indicate when the instructions for use have been revised and to inform each user of the device thereof if the revision was necessary for safety reasons;

(9)

for devices with a defined expiry date, except implantable devices, they shall keep the instructions for use available for users in electronic form for 10 years after the last device has been placed on the market and at least 2 years after the end of the expiry date of the last produced device;

(10)

for devices without a defined expiry date and implantable devices, they shall keep the instructions for use available for the users in electronic form for 15 years after the last device has been placed on the market;

(11)

the instructions for use shall be available on their website in an official language of the Union determined by the Member State in which the device is made available;

(12)

During the periods set out in points (9) and (10), all issued electronic versions of the instructions for use and their date of publication shall be available on the website or, as regards versions that are obsolete, be made available upon request;.

注：制造商应在网站长期保留所有已发布的使用说明书电子版本及发布日期，关于过时版本，应按要求提供。

(a)

any information needed to view the instructions for use;

(b)

the Basic UDI-DI and/or the UDI-DI of the device, as respectively referred to in Article 27(6) and Article 27(1), point (a)(i), of Regulation (EU) 2017/745, and any additional information allowing the identification of the device, including its name and if applicable the model;

(c)

relevant manufacturer contact details e.g. manufacturer’s name, address, email address or other means of online communication and website;

(d)

where and how instructions for use in paper form can be requested and within which time they shall be obtained at no additional cost in conformity with Article 5, point (3).

(a)

the instructions for use shall be provided in a commonly used format that can be read with freely available software;

(b)

it shall be protected against unauthorized access and tampering of content in accordance with Article 4(1), point (e);

(c)

it shall be provided in such a way that the server downtime and display errors are reduced as far as possible;

(d)

it shall fulfil the requirements of Regulation (EU) 2016/679;

(e)

the internet address as displayed in accordance with Article 6(2) shall be stable and directly accessible during the periods set out in Article 5, points (9) and (10);

(3)  At the latest at the date from which the registration of devices in the UDI database referred to in Article 28 of Regulation (EU) 2017/745 applies in accordance with Article 123(3), point (d) or point (e), of that Regulation, as applicable, the manufacturer shall provide the internet address referred to in paragraph (2), point (e), of this Article to the UDI database in accordance with Part B, point 22, of Annex VI to Regulation (EU) 2017/745.

注：自医疗器械在Eudamed注册成为强制性要求之日起，制造商应向Eudamed中的UDI数据库提供可访问电子版使用说明的互联网地址。