Resources

The following resources are provided for your convenience, wherever possible the relevant weblink is provided, rather than an actual document. You should always check that you are using the most up-to-date versions*. 

MDCG Endorsed Guidance Documents

MDCG timetable of readiness

Click Here - Opens web page with further links to all of the following:

  • UDI

  • EUDAMED

  • EMDN (European Medical Device Nomenclature)

  • Notified Bodies

  • Clinical Investigation and Evaluation

  • New Technologies

  • "Other topics"

  • Commission guidance documents

MEDDEV Guidance Documents

Click Here - opens PDF document with links to all of the following:

MEDDEV 2.1 Series - Scope, field of application, definition

MEDDEV 2.2 Series - Essential requirements

MEDDEV 2.4 Single Document - Classification of MD

MEDDEV 2.5 Series - Conformity assessment procedure

MEDDEV 2.7 Series - Clinical investigation, clinical evaluation

MEDDEV 2.10 Series - Notified Bodies

MEDDEV 2.12 Series - Post market surveillance

MEDDEV 2.13 Series - Transitional period

MEDDEV 2.14 Series - IVD

MEDDEV 2.15 Series - Other

Device Specific Vigilance Guidance 

Other Useful Information

Current Notified Body Lists

UK Approved Bodies

Link to new UK database will appear here

Automatic Approval:

  • BSI - AIMDD, MDD, IVDD

  • SGS - MDD, IVDD

  • UL - IVDD

New Regulations -Nando: Notifed Bodies

Notified Bodies MDR

Notified Bodies IVDR

Existing Directives - Nando: Notified Bodies

Notified Bodies MDD

Notified Bodies IVDD

Notified Bodies AIMDD

The Independent Medicines & Medical Devices Safety Review - The Cumberlege Review

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