MDCG 2019-12

DOCX · primary

Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.

Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

Date
Country of the designating authority and name (optional)
Name of the conformity assessment body (CAB) / notified body (NB) and identification number (if applicable)
Date of on-site assessment	Purpose of the assessment	Tick
Initial designation	☐
Date of follow up on-site assessment (if applicable)	Renewal of designation	☐
Scope extension
Regulation			Tick
Regulation (EU) 745/2017			☐
Regulation (EU) 746/2017			☐

Summary of the designating authority assessment
Brief description of the assessment carried out by the designating authority
Please provide a summary of the result of the assessment carried out by the designating authority
Have all corrective and preventive actions been appropriately addressed and, where required, implemented?	Yes
No
Provide a justification if the answer is NO

Remaining diverging opinions
Is there any remaining diverging opinion with the JAT?		Yes
No
1	If applicable, please provide information on any remaining diverging opinions with the JAT including: - designating authority's opinions raised on-site, and - any updates to these opinions
2	See above

Designating authority recommendation for designation (Tick as applicable)
Designation of the CAB / NB not recommended Designation of the CAB / NB recommended Designation of the CAB / NB recommended with the following condition(s):
1	Provide information on any conditions to be established as part of the designation
2	See above

Designating authority recommended scope of designation (Tick as, and if, applicable)
See appended form <insert file name> (based on "NBOG F 2017-3")	☐
See appended form <insert file name> (based on "NBOG F 2017-4")	☐
Scope of designation proposed by designating authority is the same as that applied for by the CAB / NB Scope of designation proposed by designating authority is different to that applied for by the CAB / NB
In case the scope of designation proposed differs in respect to the applied for scope please provide an explanation:

List of non-conformities and designating authority's aassessment of the corrections and CAPAs proposed by the CAB / NB
No	Non-conformity	CAPAs proposed by CAB / NB	Assessment by the designating authority
Organisational and general requirements
Description on the non-conformity	Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks:	Effectiveness of CAPA
Already verified To be verified following designation
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks:	Effectiveness of CAPA
Already verified To be verified following designation
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks::	Effectiveness of CAPA
Already verified To be verified following designation
Quality management system requirements
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks::	Effectiveness of CAPA
Already verified To be verified following designation
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks::	Effectiveness of CAPA
Already verified To be verified following designation
Resource requirements
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks::	Effectiveness of CAPA
Already verified To be verified following designation
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks::	Effectiveness of CAPA
Already verified To be verified following designation
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) ☐ Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks::	Effectiveness of CAPA
Already verified To be verified following designation
Process requirements
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks::	Effectiveness of CAPA
Already verified To be verified following designation
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks::	Effectiveness of CAPA
Already verified To be verified following designation
Type of CAPAs - Tick as many as applicable Change of procedure(s) Revision of existing procedures Creation of new/additional QMS document(s) Training of personnel Rework of personnel file(s) Rework of project file(s) Contract with new internal / external personnel CAPA insufficient / missing	Non-conformity
Closed To be followed-up
Implementation of CAPA
Already verified To be verified following designation
Additional description of CAPA/remarks::	Effectiveness of CAPA
Already verified To be verified following designation

Designating authority's final assessment form: Key information (EN)

Related provisions and topics

Provisions

Topics

Source document

MDCG 2019-12