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Commission Regulation (EU) No 207/2012Show full title
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (Text with EEA relevance)
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Changes over time for: Article 5
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Commission Regulation (EU) No 207/2012, Article 5 is up to date with all changes known to be in force on or before 18 August 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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Changes and effects yet to be applied to Article 5:
- Regulation applied (with modifications) by S.I. 2002/618, reg. 4J(2) (as inserted) by S.I. 2019/791 reg. 3(7)
- Regulation applied (with modifications) by S.I. 2002/618, reg. 4J(3) (as inserted) by S.I. 2019/791 reg. 3(7)
- Regulation revoked by S.I. 2002/618, reg. 4J (as substituted) by S.I. 2021/873 Sch. 1 para. 3
Article 5U.K.
Manufacturers of devices referred to in Article 3 may provide instructions for use in electronic form instead of in paper form under the following conditions:
(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 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 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 on 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 medical 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 in 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 the users in electronic form for 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 for implantable devices, they shall keep the instructions for use available for the users in electronic form for a period of 15 years after the last device has been manufactured.
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