Retained EU Law SI 2012/207 United Kingdom

Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (Text with EEA relevance)

Read it on legislation.gov.uk (opens in a new tab)
Status
In Force
Penalty ceiling
Regulated

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer4

Plus 1 duty on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Manufacturer — also bound by 502 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

s.art004 (1) Manufacturers of devices referred to in Article 3 that... Regulated
  • Risk-assess before providing electronic instructions for medical devicesManufacturer
s.art005 Manufacturers of devices referred to in Article 3 may provide... Regulated
  • Provide electronic instructions for use safelyManufacturer
s.art006 (1) Manufacturers shall clearly indicate that the instructions for use... Regulated
  • Clearly mark packaging if you supply instructions for use electronically instead of in paperManufacturer
s.art007 (1) Where manufacturers provide the instructions for use in electronic... Regulated
  • Make electronic instructions for use available on a secure, stable websiteManufacturer
s.art008 Except for medical devices of Class I, as defined in... Regulated
Other duties (1) — Crown / regulator
  • Approved bodies must review compliance with electronic IFU rules during conformity assessmentStatutory regulator
5 other provisions — procedural and definitional
s.art001 In this Regulation a reference to an Annex to Directive...
s.art002 For the purposes of this Regulation, the following definitions shall...
s.art003 (1) Subject to the conditions set out in paragraph 2,...
s.art009 Instructions for use in electronic form which are provided in...
s.art010 This Regulation shall enter into force on the 20th day...

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.