CLINICAL EVALUATION REPORT DOCUMENTATION

1. MANUFACTURER INFORMATION
Legal Manufacturer / OEM / OBL Name*
Street*
City /Pincode*
Country*
Website Address
2. ADMINISTRATIVE INFORMATION
Notified Body Slected / Interested?	Select NB 2265-3EC NB 2797-BSI NB 1370-BUREAU VERITAS ITALIA NB 0633-BERLIN CERT GMBH NB 2409-CERTISO NB 0318-CNDC NB 0546-CERTIQUALITY NB 1912-DARE NB 0344/NB 0124-DERKA NB 2460-DNV NB 0297-DQS NB 0537/0477-EUROFINS NB 0459-GMED NB 0051-IMQ NB 0373-ISDI NB 0426-ITALCERT SRL NB 2862-INTERTEK NB 0476/1912-KIWA NB 0483-MDC NB 0482-MEDCERT NB 0050-NSAI NB 0598/1639-SGS NB 1304-SIQ NB 2274-TUV NORD POLSKA NB 0044-TUV NORD GMBH NB 0197-TUV RHEINLAND NB 0123-TUV SUD NB 2696-UDEM
Scope of Manufacturer	Select Design, Manufacturer and Sale of Device Manufacturer and Sale of Device Assembly, Packing, Labelling and Sale of Device Third-party Manufacturing and Sale of Device Own Brand Labeler(OBL)
Scope of CERT3GLOBAL	Select CER Documentation along with PMS, PMCF, PSUR, RMF and NB Coordination CER Documentation along with PMS, PMCF, PSUR, RMF without NB Coordination CER Documentation Only
Documentation experience and Device Knowledge of the person coordinate with Consultants	Select Good Average Poor
3. MEDICAL DEVICE DESCRIPTION
Name of the Medical Device
Intended use of the device
Device Brand Name / Trade Name
Number of Models	Select ONE TWO 1-5 1-10 1-20 1-40 1-100 1-1000
Class of Device as per MDR	Select Class 1 Class 1 Sterile Class 1 Measuring Class 1 Reusable Class 11 a Class 11 b Class 111
Status of EU 2017/745 Technical Documentation	Select Under Development Changeover from MDD is in progress Completed as per EU 2017/745 Will start soon
Device Body Contact	Select External Body Contact No Body Contact Limited (< 24h) Prolonged (24h to 30 days) Long Term (> 30 days)
Device Invasive action by	Select Not Applicable With the help of surgical procedure Body orifice Totally introduced into the body through surgical procedure Partially introduced into the body through surgical procedure
Medical device serve functions by	Select Self Functioning Home use Clinical Use Home and Clinical Use Combination with other medical device
Special Features	Select Software Integrated Function as a system Medicinal function
Medical Device packed	Select Sterile Non Sterile
Name the Accessories (If Nil write NA)
Name the Components (If Nil write NA)
4. SUBMITTER INFORMATION
Contact Person* Select Mr Mrs Dr Prof Ms
Job Title*
Contact Number*
Contact Email*