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*.
UK Sovereign System of Regulation
UKCA Mark: Regulating medical devices from 1 January 2021
Medicines and Medical Devices Bill Briefing Paper CBP-8699
Medicines and Medical Devices Bill 2019-21
Short to medium tem UK will be continuing with the Directives:
Consolidated Text of AIMDD 90/385/EEC
Medical Device & IVD Regulation
MDCG Endorsed Guidance Documents
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
DSVG 00 - Introduction to Device Specific Vigilance Guidance
DSVG 01 - Devices for Cardiac Ablation
DSVG 02 - Coronary Stents and associated delivery systems
DSVG 03 - Cardiac Implantable Electronic Devices (CIED)
DSVG 04 - Breast Implants
DSVG 05 - Insulin Infusion Pumps and Integrated meter systems
Other Useful Information
New MIR (Manufacturer Incident Report) form
MTE Position Paper on IVDR Delay
**NEW**: Register an a manufacturer of Medical Devices or IVDs in the UK from 1st January 2021
Register as a manufacturer of Medical Devices or IVDs (UK) (EU system)
** NEW **: Which Regulations Apply to me?
European Commission launches new Medical Device website (July 2020)#
SCHEER Guidelines
CAMD FAQ
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
Existing Directives - Nando: Notified Bodies
The Independent Medicines & Medical Devices Safety Review - The Cumberlege Review
*Terms of Use
This information is correct and up to date at the time of publishing. PRQR does not guarantee the accuracy and completeness of the information provided. This information is provided without warranty regarding fitness for a particular purpose, satisfactory quality or freedom from hidden defects. Any person relying on any of the information contained on this website or making any use of the information contained herein, shall do so at its own risk.
To the fullest extent permitted by law, PRQR hereby disclaims any liability and in no event shall PRQR be liable for any damage including, without limitation, direct, indirect or consequential damages including loss of revenue, loss of profit, loss of opportunity or other loss arising from the use of or the inability to use the information contained on this website including damages arising from inaccuracies, omissions or errors.