Retained EU Law SI 2002/364 United Kingdom

Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344) (Text with EEA relevance) (2002/364/EC)

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

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.

uri:annex/division/3/division/10/division/1/division/1 uri:annex/division/3/division/10/division/1/division/1 Regulated
  • Ensure every reagent batch gives the expected positive/negative resultManufacturer
uri:annex/division/3/division/3.4 uri:annex/division/3/division/3.4 Regulated
  • Test every batch against at least 100 negative specimensManufacturer
uri:annex/division/3/division/3.5 uri:annex/division/3/division/3.5 Regulated
  • Conduct performance evaluations of blood group reagents to European specificationsManufacturer
uri:annex/division/3/division/3.6 uri:annex/division/3/division/3.6 Regulated
  • Ensure batch release testing consistently identifies relevant antigens/antibodiesManufacturer
2 other provisions — procedural and definitional
s.art001 The technical specifications set out in the Annex to this...
s.art002 This Decision is addressed to the Member States.

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