Section A — Administrative particulars

Source: MDCG-2020-01.pdf page 6 (document: MDCG 2020-13, Clinical evaluation assessment report template, July 2020)

Template CEAR

Section A: Administrative particulars (notified body, manufacturer, product and clinical evaluation report reference)

Device and manufacturer identification

Field	Value
Medical device name model and type	_____
Project number	_____
Risk Class	_____
Applicable code(s) per Commission Implementing Regulation (EU) 2017/2185	_____
Manufacturer(s) name and SRN	_____
Authorised representative (if applicable) name and SRN	_____
Intended purpose	_____

• Basic UDI-DI(s) (if available): _____
• Certificate number (if applicable): _____

Notified body contact

Field	Value
Notified body	_____
Notified body number	_____
E-mail contact of NB	_____
Telephone contact of NB	_____

Type of assessment

• Initial conformity assessment
• Assessment of changes¹ and update of the clinical evaluation²
• Re-certification assessment
• Assessment of technical documentation for class IIa / IIb devices on a sampling basis

Check of clinical evaluation report authors

• CER dated and signed
• CVs provided for CER author(s)

Comments:

Confirm CVs are up to date

Confirm CER authors have full range of required expertise represented (e.g. research methods, information

Parts of this template which have been applied

General considerations³

• Section A: Administrative particulars
• Section B: Reviewers involved
• Section C: Device description, classification, clinical evaluation plan, information materials supplied by the manufacturer, common specifications and harmonised standards applied, equivalence and state of the art
• Section D: Clinical literature review
• Section E: Clinical investigations and related documentation
• Section F: PMS and PMCF
• Section G: IFU, SSCP, labelling and other information supplied with the device
• Section H: Summary of all available data and conclusions
• Overall Conclusions

Specific Considerations

Footnotes

1. MDR, Annex IX Section 4.10 ↩

2. For example in accordance with Annex VII, Section 4(10) ↩

3. These must be completed in all cases ↩