Implementing Regulation (EU) 2021/2226 is amended as follows:

in Article 1, the third subparagraph is deleted;

Article 2 is amended as follows:

in point (2), the word ‘medical’ is deleted;

point (3) is replaced by the following:

“fixed installed 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.’;

Article 3 is amended as follows:

paragraph (1) is replaced by the following:

‘(1) Manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to devices referred to in Article 1(4) of Regulation (EU) 2017/745 intended for use by professional users.’

paragraph (2) is replaced by the following:

‘(2) Where it is reasonably foreseeable that a device intended for use by professional users is also used by lay persons, manufacturers shall provide the instructions for use intended for lay persons in paper form.’

Article 5 is amended as follows:

in point (6), the word ‘medical’ is deleted;

in point (11), the words ‘to the user or patient’ are deleted;

point (12) is deleted;

point (13) is replaced by the following:

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.’;

Article 6 is amended as follows:

in paragraph (1), second subparagraph, second sentence, the word ‘medical’ is deleted;

paragraph (4) is deleted;

Article 7 is amended as follows:

in paragraph 2, point (f) is deleted;

the following paragraph is added:

‘(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.’

Article 8 is deleted;

in Article 9, the second paragraph is deleted.

COMMISSION IMPLEMENTING REGULATION (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form