(1) Manufacturers of devices referred to in Article 3 that...
- Risk-assess before providing electronic instructions for medical devices
Retained EU Law
2012
United Kingdom
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (Text with EEA relevance)
At a glance
What's here
5 compliance obligations
Who this Act binds
Plus 1 non-business duty on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Manufacturers of devices referred to in Article 3 may provide...
- Provide electronic instructions for use safely
(1) Manufacturers shall clearly indicate that the instructions for use...
- Clearly mark packaging if you supply instructions for use electronically instead of in paper
(1) Where manufacturers provide the instructions for use in electronic...
- Make electronic instructions for use available on a secure, stable website
Except for medical devices of Class I, as defined in...
Other duties (1) — Crown / regulator
- Approved bodies must review compliance with electronic IFU rules during conformity assessment Statutory regulator
Browse 5 other sections — procedural / definitional / commencement
In this Regulation a reference to an Annex to Directive...
For the purposes of this Regulation, the following definitions shall...
(1) Subject to the conditions set out in paragraph 2,...
Instructions for use in electronic form which are provided in...
This Regulation shall enter into force on the 20th day...
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