TrendReport.doc

Report Form Manufacturer’s Trend Report Medical Devices Vigilance System (MEDDEV 2.12/1 rev 7) v.12/11 1. Administration Information Top of Form Recipient (Name of National Competent Authority NCA) Address of National Competent Authority Date of this report Reference number assigned by the manufacturer Reference number assigned by NCA Type of report Trend Initial Trend Follow up Trend Final Do these incidents / trend represent a serious public health threat? Yes No Identify to what other NCAs this report was also sent 2. Information on submitter of the report Status of submitter Manufacturer Authorised Representative within EEA, Switzerland and Turkey Others: (identify the role) : 3. Manufacturer information Name Contact name Address Postcode City Phone Fax E-mail Country 4. Authorised Representative information Name Contact name Address Postcode City Phone Fax E-mail Country 5. Submitter’s information (if different from section 3 or 4) Submitter’s name Contact name Address Postcode City Phone Fax E-mail Country Bottom of Form 6. Medical Device Information Class AIMD Active Implants MDD Class III MDD Class IIb MDD Class IIa MDD Class I IVD Annex II List A IVD Annex II List B IVD Devices for self-testing IVD General Nomenclature system (preferable GMDN) Nomenclature code Nomenclature text Commercial name/ brand name / make Model number(s) or Family name Catalogue number(s) Serial number range (if applicable) Lot/batch number range(if applicable) Software version number (if applicable) Accessories / associated devices (if applicable) Notified Body (NB) ID – Number 7. Information on Trend Report Date the trend was identified Description narrative for identified trend Time period of trend analysis Established trigger level Have any of the trended events been submitted individually as reportable events under vi