Regulatory advice contact list for devices

Subject area Contacts Telephone number
Advertising David Batten
John Farquharson
020 3080 7254
020 3080 7211
Assembly/Procedure Packs (Article 12 of the MDD) Dhruti Patel
Rob Higgins
020 3080 7194
020 3080 7185
Audit of Notified Bodies Dhruti Patel 020 3080 7194
CE Marking - General process and understanding David Batten
John Farquharson
020 3080 7254
020 3080 7211
CE Marking - product specific Clare Headley
Dhruti Patel
020 3080 7386
020 3080 7194
Classification of Devices Clare Headley
Dhruti Patel
020 3080 7386
020 3080 7194
Clinical Investigations Daniella Smolenska
Hamira Rashid
020 3080 7363
020 3080 7258
Compliance David Batten (Policy)
Bruce Petrie (Casework)
Ranulf Barman (Compliance Legislation)
020 3080 7254
020 3080 7335
020 3080 6311
Conformity Assessment Routes Dhruti Patel
Clare Headley
020 3080 7194
020 3080 7386
Dental Labs - Register of Angela Bartley
Barbara Clarke
Jasu Patel
020 3080 7149
020 3080 7318
020 3080 7195
European Database (EUDAMED) Rob Higgins
Daniella Smolenska
020 3080 7185
020 3080 7363
Fees - Notified Body Dhruti Patel 020 3080 7194
Fees - Registration /Clinical Investigation Angela Bartley
Daniella Smolenska
020 3080 7149
020 3080 7363
In-house manufacturing David Batten
John Farquharson
020 3080 7254
020 3080 7211
ISO Quality Systems Standards Dhruti Patel
Clare Headley
020 3080 7194
020 3080 7386
IVD borderline Clare Headley
Rob Higgins
020 3080 7386
020 3080 7185
Labelling - General David Batten 020 3080 7254
Labs - Register of Angela Bartley
Barbara Clarke
Jasu Patel
020 3080 7149
020 3080 7318
020 3080 7195
Language Issues David Batten
John Farquharson
020 3080 7254
020 3080 7211
Medical devices borderline Clare Headley
Dhruti Patel
020 3080 7386
020 3080 7194
Medicine/medical device borderline Clare Headley
Rob Higgins
020 3080 7386
020 3080 7185
Mutual Recognition Agreements/CABs Rob Higgins
Dhruti Patel
020 3080 7185
020 3080 7194
Nomenclature (GMDN) Rob Higgins
Daniella Smolenska
020 3080 7185
020 3080 7363
Notified Bodies Dhruti Patel 020 3080 7194
Own Brand Labelling David Batten
John Farquharson
020 3080 7254
020 3080 7211
PCA Form Daniella Smolenska
Hamira Rashid
020 3080 7363
020 3080 7258
Performance evaluation Daniella Smolenska
Rob Higgins
020 3080 7363
020 3080 7185
Quality Assurance (inc. ISO 9000/13485) Dhruti Patel
Clare Headley
020 3080 7194
020 3080 7386
Parallel Imports David Batten
John Farquharson
020 3080 7254
020 3080 7211

Registration - A-Z by Name/Company

- A-D
- E-M
- N-Z


Jasu Patel
Barbara Clarke
Angela Bartley

020 3080 7195
020 3080 7318
020 3080 7149
RG2 Form Applications Jasu Patel
Barbara Clarke
020 3080 7195
020 3080 7318
RG3 Form Applications Jasu Patel
Barbara Clarke
020 3080 7195
020 3080 7318
Technical interpretations Dhruti Patel
Clare Headley
020 3080 7194
020 3080 7386
TSE NB Reviews Dhruti Patel
Joe Hagan Brown
020 3080 7194
020 3080 6786
     
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 3080 7080
Vigilance systems Tony Sant
Roy Saunders
020 3080 7288
020 3080 7187


Page last modified: 16 July 2014