Regulatory advice contact list for devices

Subject area Contacts Telephone number
Advertising David Batten
John Farquharson		 020 7084 3254
020 7084 3211
Assembly/Procedure Packs (Article 12 of the MDD) Tore Johansen
Rob Higgins		 020 7084 3235
020 7084 3185
Audit of Notified Bodies Tore Johansen
Clare Headley		 020 7084 3235
020 7084 3386
CE Marking - General process and understanding David Batten
Liz Evans		 020 7084 3254
020 7084 3042
CE Marking - product specific Clare Headley
Tore Johansen		 020 7084 3386
020 7084 3235
Classification of Devices Clare Headley
Tore Johansen		 020 7084 3386
020 7084 3235
Clinical Investigations Daniella Smolenska
Rebecca Sugden		 020 7084 3363
020 7084 3258
Compliance David Batten
Bruce Petrie		 020 7084 3254
020 7084 3335
Conformity Assessment Routes Tore Johansen
Clare Headley		 020 7084 3235
020 7084 3386
Dental Labs - Register of Angela Bartley
Sean Williams
Jasu Patel		 020 7084 3149
020 7084 3325
020 7084 3195
European Database (EUDAMED) Rob Higgins
Daniella Smolenska		 020 7084 3185
020 7084 3363
Fees - Notified Body Tore Johansen 020 7084 3235
Fees - Registration /Clinical Investigation Angela Bartley
Daniella Smolenska		 020 7084 3149
020 7084 3363
In-house manufacturing David Batten
John Farquharson		 020 7084 3253
020 7084 3211
ISO Quality Systems Standards Tore Johansen
Clare Headley		 020 7084 3235
020 7084 3386
IVD borderline Clare Headley
Rob Higgins		 020 7084 3386
020 7084 3185
Labelling - General David Batten 020 7084 3253
Labs - Register of Angela Bartley
Sean Williams
Jasu Patel		 020 7084 3149
020 7084 3325
020 7084 3195
Language Issues David Batten
John Farquharson		 020 7084 3253
020 7084 3211
Medical devices borderline Clare Headley
Tore Johansen		 020 7084 3386
020 7084 3235
Medicine/medical device borderline Clare Headley
Rob Higgins		 020 7084 3386
020 7084 3185
Mutual Recognition Agreements/CABs Rob Higgins
Tore Johansen		 020 7084 3185
020 7084 3235
Nomenclature (GMDN) Rob Higgins
Daniella Smolenska		 020 7084 3185
020 7084 3363
Notified Bodies Tore Johansen
Clare Headley		 020 7084 3235
020 7084 3386
Own Brand Labelling David Batten
Richard Gutowski		 020 7084 3254
020 7084 3253
PCA Form Daniella Smolenska
Rebecca Sugden		 020 7084 3363
020 7084 3258
Performance evaluation Daniella Smolenska
Rob Higgins		 020 7084 3363
020 7084 3185
Quality Assurance (inc. ISO 9000/13485) Tore Johansen
Clare Headley		 020 7084 3235
020 7084 3386
Parallel Imports David Batten
John Farquharson		 020 7084 3254
020 7084 3211

Registration - A-Z by Name/Company
- A-J
- K-Z
Initial Enquiries
Jasu Patel
Sean Williams
Angela Bartley
Daniella Smolenska
020 7084 3195
020 7084 3325
020 7084 3149
020 7084 3363
RG2 Form Applications Jasu Patel
Sean Williams		 020 7084 3195
020 7084 3325
RG3 Form Applications Jasu Patel
Sean Williams		 020 7084 3195
020 7084 3325
Requests for publications Chandra Shukla 020 7084 3212
Technical interpretations Tore Johansen
Clare Headley		 020 7084 3235
020 7084 3386
Transition periods David Batten
John Farquharson		 020 7084 3254
020 7084 3211
TSE NB Reviews Tore Johansen
Akpo Whitney		 020 7084 3235
020 7084 3194
     
Devices Technology and Safety dealing with technical questions on specific devices by product field A-Z listing  
Reporting vigilance cases/Adverse incident reports General 020 7084 3080
Vigilance systems Tony Sant
Roy Saunders		 020 7084 3288
020 7084 3187


Page last modified: 07 February 2008