1. REVIEW TECHNICAL FILE AND PMS
The MDR requirements related to technical file and PMS are reported in Annex II and Annex
III. Here below a representation is reported:
Required Content of Technical Documentation as per MDR
(a) Annex II – Technical Documentation:
1. Device description and specification, including variants and accessories
1.1 Device description and specification
1.2 Reference to previous and similar generations of the device
2.
3.
4.
5.
6.
Information to be supplied by the manufacturer
Design and manufacturing information
General safety and performance requirements
Benefit-risk analysis management
Product verification and validation
6.1 Pre-clinical and clinical data
6.2 Additional information required in specific cases
(b) Annex III – Technical Documentation on Post Market Surveillance:
1. The post-market surveillance plan
2. The PSUR (Periodic Safety Update Report)
3. PMS Report
A copy for the technical documentation (if applicable including STED = summary technical
documentation), the declaration of conformity and (if applicable) the certificate available for
CA must be kept for 10 (15 for implantable device) years after the device is placed on market.
This assessment is really peculiar to every company and product. We can help you out by
reviewing existing documentation or setting up the Technical File and PMS file according to
MDR.
11.1 Periodic Safety Update Report (PSUR) - Article 86
The main requirements for PSUR are defined in Article 86.
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Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety
update report ('PSUR') for each device and where relevant for each category or group of
devices
Manufacturers of class IIb and III devices shall update the report at least annually
Manufacturers of class IIa devices shall update the report when necessary and at least every
two years
For class III or implantable devices shall submit PSUR reports by means of the electronic
system to the notified body
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Notified Body shall review, add its evaluation with details of any action taken, and make
available to the Competent Authorities through the electronic system
MDR – Article 86 – Periodic safety update report
Article 86
Periodic safety update report
1. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic
safety update report (‘PSUR’) for each device and where relevant for each category or
group of devices summarising the results and conclusions of the analyses of the post market surveillance data gathered as a result of the post-market surveillance plan
referred to in Article 84 together with a rationale and descri ption of any preventive
and corrective actions taken. Throughout the lifetime of the device concerned, that
PSUR shall set out:
Throughout the lifetime of the device concerned the PSUR shall set out:
o
o
o
o
o
Conclusions of the benefit risk determination
Main findings of PMCF
Volume of Sales
Estimate of the size and other characteristics of the Population that use the device
Where practicable usage frequency of the device
Here below the PSUR requirement per type of products:
Class I
Class Is / Im / Ir
PSUR
SSCP
Strictly N/A however Article 85 –
Class I PMS Report updated ‘when
necessary’
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Class IIa
As necessary and at least every 2
years
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Class IIb
Annual
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Class IIb
Implantable
Annual to NB (EUDAMED)
Annual to NB
(EUDAMED)
Class III
Annual to NB (EUDAMED)
Annual to NB
(EUDAMED)
11.2 Summary of Safety & Clinical Performance (SSCP) - MDR - Article 32
For implantable device sand for class III devices, the manufacturer shall draw up a summary
of safety and clinical performance. The SSCP shall be written in a way that is clear to the
intended user and, if relevant, to the patient and shall be made available to the public via
EUDAMED.
SSCP shall include at least the following:
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Manufacturer + SRN
Device + UDI DI
Intended Purpose, Indications, Contra indications and Target Population
Description, previous variant(s), differences, accessories, other products intended to be
used in Combination
Possible diagnostic or therapeutic alternatives
Harmonised Standards / Common Specifications
Summary of the Clinical Evaluation Report + PMCF
Suggested profile and training for users
Information on residual risks, undesirable effects, warnings & precautions
As per Article 61: Clinical Evaluation for class III devices and implantable devices, the PMCF
evaluation report and, if indicated, the summary of safety and clinical performance (referred to
in Article 32) shall be updated at least annually with such data”
(a)
(b)
(c)
the conclusions of the benefit-risk determination;
the main findings of the PMCF; and
the volume of sales of the device and an estimate evaluation of the
size and other characteristics of the population using the device and,
where practicable, the usage frequency of the device.
Manufacturers of class IIb and class III devices shall update the PSUR at least
annually. That PSUR shall, except in the case of custom-made devices, be part of the
technical documentation as specified in Annexes II and III.
Manufacturers of class IIa devices shall update the PSUR when necessary and at least
every two years. That PSUR shall, except in the case of custom-made devices, be part
of the technical documentation as specified in Annexes II and III.
For custom-made devices, the PSUR shall be part of the documentation referred to in
Section 2 of Annex XIII.
2. For class III devices or implantable devices, manufacturers shall submit PSURs by
means of the electronic system referred to in Article 92 to the notified body involved
in the conformity assessment in accordance with Article 52. The notified body shall
review the report and add its evaluation to that electronic system with details of any
action taken. Such PSURs and the evaluation by the notified body shall be made
available to competent authorities through that electronic system.
3. For devices other than those referred to in paragraph 2, manu facturers shall make
PSURs available to the notified body involved in the conformity assessment and, upon
request, to competent authorities.