Essentials of European Medical Device Regulatory Affairs

Submit to NB if required

• Considerations for choosing a NB: – Can I work with these people? – Do these people understand my technology? – Do we share: testing, validation & clinical approach? – Consider who your contractors and competitors use – Consider weakness of the NB, e.g. use of consultants – Will their reputation enhance mine? – Will there be language issues? – Is my NB sustainable? Multisite? – What is the time and cost – will quotes hold? • Factor into your product launch plans!

• Sign the declaration of conformity – Declared by the manufacturer – Only once the technical documentation is complete and necessary certificates received – Batch or date or version/substantial change expiry – DoC should include:- • Name of the device, model number (sku) and trade name • Manufacturer (and EUAR) name and address • Name and number of your Notified Body (if applicable) • Your CE Marking certificate number (if applicable) • Your conformity assessment route to compliance. List the Annex, classification and rule number • National Laws in country where declaration is made (sometimes) • Harmonized Standards relied upon for conformity • Name and signature of a senior management representative and date signed – should be Officer or Director of Company – Only 1 DoC for all EEA plus Switzerland (Turkey) Manufacturer or EUAR country sets jurisdiction of declaration