Regulatory advice contact list for devices

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Subject area	Contacts	Telephone number
Advertising	David Batten John Farquharson	020 3080 7254 020 3080 7211
Assembly/Procedure Packs (Article 12 of the MDD)	Tore Johansen Rob Higgins	020 3080 7235 020 3080 7185
Audit of Notified Bodies	Tore Johansen Clare Headley	020 3080 7235 020 3080 7386
CE Marking - General process and understanding	David Batten John Farquharson	020 3080 7254 020 3080 7211
CE Marking - product specific	Clare Headley Tore Johansen	020 3080 7386 020 3080 7235
Classification of Devices	Clare Headley Tore Johansen	020 3080 7386 020 3080 7235
Clinical Investigations	Daniella Smolenska Hamira Rashid	020 3080 7363 020 3080 7258
Compliance	David Batten Bruce Petrie	020 3080 7254 020 3080 7335
Conformity Assessment Routes	Tore Johansen Clare Headley	020 3080 7235 020 3080 7386
Dental Labs - Register of	Angela Bartley Sean Williams Jasu Patel	020 3080 7149 020 3080 7325 020 3080 7195
European Database (EUDAMED)	Rob Higgins Daniella Smolenska	020 3080 7185 020 3080 7363
Fees - Notified Body	Tore Johansen	020 3080 7235
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	Tore Johansen Clare Headley	020 3080 7235 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 Sean Williams Jasu Patel	020 3080 7149 020 3080 7325 020 3080 7195
Language Issues	David Batten John Farquharson	020 3080 7254 020 3080 7211
Medical devices borderline	Clare Headley Tore Johansen	020 3080 7386 020 3080 7235
Medicine/medical device borderline	Clare Headley Rob Higgins	020 3080 7386 020 3080 7185
Mutual Recognition Agreements/CABs	Rob Higgins Tore Johansen	020 3080 7185 020 3080 7235
Nomenclature (GMDN)	Rob Higgins Daniella Smolenska	020 3080 7185 020 3080 7363
Notified Bodies	Tore Johansen Clare Headley	020 3080 7235 020 3080 7386
Own Brand Labelling	David Batten	020 3080 7254
PCA Form	Daniella Smolenska Rebecca Sugden	020 3080 7363 020 7084 3258
Performance evaluation	Daniella Smolenska Rob Higgins	020 3080 7363 020 3080 7185
Quality Assurance (inc. ISO 9000/13485)	Tore Johansen Clare Headley	020 3080 7235 020 3080 7386
Parallel Imports	David Batten John Farquharson	020 3080 7254 020 3080 7211
Registration - A-Z by Name/Company - A-J - K-Z Initial Enquiries	Jasu Patel Sean Williams Angela Bartley Daniella Smolenska	020 3080 7195 020 3080 7325 020 3080 7149 020 3080 7363
RG2 Form Applications	Jasu Patel Sean Williams	020 3080 7195 020 3080 7325
RG3 Form Applications	Jasu Patel Sean Williams	020 3080 7195 020 3080 7325
Requests for publications	Chandra Shukla	020 3080 7212
Technical interpretations	Tore Johansen Clare Headley	020 3080 7235 020 3080 7386
Transition periods	David Batten John Farquharson	020 3080 7254 020 3080 7211
TSE NB Reviews	Tore Johansen Akpo Whitney	020 3080 7235 020 3080 7194

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: 02 February 2012