SSCP & PSUR

Reporting Requirements

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70
 Article 32 - Summary of Safety and Clinical Performance (SSCP)
• In the case of devices classified as class III and implantable
devices, the manufacturer shall draw up a summary of safety • Manufacturer + SRN
and clinical performance.
• Device + UDI
• It shall be written in a way that is clear to the intended user • Intended Purpose, Indications, Contra-indications
and, if relevant, to the patient and shall be available to the
• Description, previous variant(s), differences, accessories,
public via EUDAMED.
other products intended to be used in combination
• The draft of this summary shall be submitted to the notified
• Possible diagnostic or therapeutic alternatives
body and shall be validated by that body. After validation the
• Harmonised Standards / Common Specifications
notified body shall upload this summary report to Eudamed.
The manufacturer shall mention on the label or instructions for • Summary of the Clinical Evaluation Report + PMCF
use where the summary report is available. • Suggested profile and training for users

Article 49 – Clinical Evaluation • Information on residual risks, undesirable effects,

warnings & precautions
For devices classified as class IIIand implantable devices,
the PMCF report and, if indicated, the summary of safety
and clinical performance shall be updated at least annually
with these data.
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 Article 86 – Periodic Safety Update Report
• Manufacturers of class IIa, class IIb and class III
devices shall prepare a PSUR for each device and
where relevant for each category or group of devices
summarising the results and conclusions of the
analyses of the PMS data gathered ...
• Throughout the lifetime of the device concerned that
PSUR shall set out:
• Article 86 – PSUR:
• Conclusions of the benefit risk
determination
• Main findings of PMCF
• Volume of Sales
• Estimate of the Population that use
the device
• Where practicable usage frequency
of the device
• Manufacturers of class IIb and III devices shall update the report at
least annually.
Manufacturers of class IIa devices shall update the report at least
•
every two years.
• For custom-made devices the PSUR shall be part of the
documentation referred to Annex XIII.
• Manufacturers of devices in class III or implantable devices shall
submit reports by means of the electronic system to the notified
body.
• The notified body shall review and add its evaluation to that
electronic system with details of any action taken. Such PSURs and
the notified body evaluation shall be made available to competent
authorities through that electronic system.
• For devices other than class III or implantable, manufacturers shall
make PSURs available to the notified body involved in the conformity
assessment and, upon request, to competent authorities.
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.

Clinical Evaluation/PSUR/SSCP/Clinical Evaluation Assessment Report (CEAR)

Review and Manufacturer Review and
Evaluation Evaluation
by NB by NB
Eudamed PSUR SSCP Eudamed
Clinical Evidience

Class III Implants & IIb Active Devices

Competent administering/removing medicinal substances Patients
Authorities Public

Commission CEAR Prepared by NB

CECP, Article 54: “Expert NB Issues Competent Scrutiny,

Clinical Evaluation Panel” Certificate Authorities Article 55
Consultation Procedure
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 Clinical Evaluation
Consultation Procedure

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74
75

Changes to Conformity Assessment Procedures

CECP (Chapter V, Article 54)

• Applies to Class III implants and Class IIb

active device intended to administer or remove
Article 54(3):
a medicinal product
• NBs must notify CAs and
• Does not apply to : Commission through
 Certificate renewals Eudamed of decision of
whether or not this
 Design modifications where manufacturer consultation is to be applied
satisfactorily demonstrates to NB that risk-benefit
ratio is unaffected • Notification shall be
accompanied by CEAR
 Clinical evaluation CS exists for that device type,
and NB confirms that the CER meets CS
requirements

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Class III implants and some Class IIb active devices
(Article 54; Annex IX, Section 5.1, Article 55)
Notified Notified
Body 21 days 39 days Body
Review Review
• Restrict indications

No ‘scientific opinion’
• Limit duration of
Class III Implant or IIb
active drug delivery

NB Further Review

Complete Conformity
NB must

Assessment
certificate
EU Commission

• Manufacturer’s • Benefit:Risk
Clinical Evaluation • Undertake specific justify if
Determination PMCF studies
• NB Clinical • Consistency
expert panel
• Adapt IFU or
Evaluation with advice not
Assessment Report Summary of Safety
indications and Clinical followed
• PMCF Plan • PMCF Plan Performance
• Impose other
restrictions

Notified Body Notified Body

Certificate Certificate
76
 Conclusion

• Classification rules – Annex VIII Added clarifications & new rules

• Conformity Assessment – Annex IX to Annex XI CECP - Class III implantable, certain Class IIb

• General Safety and Performance – Annex I Increased from 13 to 23

• Technical File Documentation – Annex II Prescriptiverequirements

• Risk Management Alignmentwith EN ISO 14971:2012

• Clinical Evidence Prescriptive requirements

77
Where can I find full details of the changes?

bsigroup.com/MDR-revision
bsigroup.com/IVDR-revision

Webinars: bsigroup.com/webinars
Whitepapers: bsigroup.com/whitepapers

Please ask if you want any extra

information from BSI.

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79

MDR Impact on QMS and BSI

Assessments

79
Now
MDD
AIMD
ISO
IVDD
13485
Assessment Assessment
ISO Requirements
Requirements 9001

BSI QMS AUDIT

8
80
0
Future

MDR /
ISO MDD
IVDR
13485

Assessment ISO
9001
Assessment
Requirements MDSAP Requirements

‘Post market’ aspects

MDR – 26 May 2020
IVDR – 26 May 2022

BSI QMS AUDIT

8
81
1
82

BSI QMS Audits

• What is the
procedure?

• Show me the
process

• What is the
defined and
documented
system for…

• Do you have
evidence of?

82
BSI Audits for MDR Certification No changes as a
•
result of MDR /
IVDR

Unannounced • New frequencies

Audits already applied
Quality
System (ongoing per
• Once per 3 years for
MDD / MDR)
Audits Class III & Implants

• Once per 5 years for

rest

Microbiology
Technical
& Sterilisation
Documentation
Audits
Reviews

83