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TABLE OF CONTENTS

TABLE OF CONTENTS .................................................................................................................... 1

1. Abbreviations and definitions................................................................................................ 2
2. PSUR Data ............................................................................................................................ 3

2.1 Background Information ............................................................................................................ 3

2.1.1 Device description ........................................................................................................................................... 3
2.1.2 Target Market description ............................................................................................................................... 3
2.1.3 Recommended frequency of use .................................................................................................................... 3

2.2 Worldwide Commercialization Status......................................................................................... 4

2.3 Overview of exposure and safety data ....................................................................................... 6
2.3.1 Actions taken in the reporting interval for safety reasons .............................................................................. 6
2.3.2 Changes to reference safety information........................................................................................................ 6
2.3.3 Findings from Clinical Trials and other sources ............................................................................................... 6
2.3.4 Lack of efficacy ................................................................................................................................................ 7

2.4 Clinical Data review ................................................................................................................... 7

3. Risk Evaluation ..................................................................................................................... 9

3.1 Evaluation of risks and new information .................................................................................... 9

3.2 Characterization of risks ............................................................................................................ 9

4. Benefit-Risk balance............................................................................................................ 10

4.1 Recommendations on benefit-risk balance ............................................................................... 11

5. Assessment conclusions and actions .................................................................................... 12

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Elaborated by: Reviewed by:

Date & Signature Date & Signature

1. Abbreviations and definitions

AR Adverse Reaction

AE Adverse Event

SAE Serious Adverse Event

SAR Serious Adverse Reaction

AEMPS Agencia Española del Medicamento y Producto Sanitario

EEA European Economic Area

EMA European Medicines Agency

EU European Union

LEE Lack of Expected Efficacy

PSUR Periodic safety updates report

SOP Standard Operation Procedure

SPC Summary of Product Characteristics

PI Product Information

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2. PSUR Data

2.1 Background Information

This is the assessment of PSUR(s) for (Device name).

PERIODIC SAFETY UPDATE REPORT

Product Name: MOWOOT II

PSUR Nº: PSUR_XXXX_YYYY

Legal Manufacturer: usMIMA S.L.

Address: Avinguda Cornellà 142, 3-4, 08950 Esplugues de Llobregat

Contact Person: Marc Benet Pozo

Telephone Nº: (+34) 93 510 66 53

Period Covered: From DD.MM.YYYY to DD.MM.YYYY

Date of Initial placing Date and Country

on the market:

Date of the Report: DD.MM.YYYY

Date of next Report DD.MM.YYYY

2.1.1 Device description

(Add a exhaustive device description).

2.1.2 Target Market description

(Add a exhaustive target market description).

2.1.3 Recommended frequency of use

(Frequency of use description).

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2.2 Worldwide Commercialization Status

(Please state in which countries your product has a marketing authorisation and since when)

Country Commercialization Sales Nº of patients

Date Volume reacted in SARS

Germany

Belgium n.a. n.a. n.a.

France n.a. n.a. n.a.

Italy n.a. n.a. n.a.

Luxembourg n.a. n.a. n.a.

Netherlands

Denmark n.a. n.a. n.a.

Ireland n.a. n.a. n.a.

United Kingdom

Greece n.a. n.a. n.a.

Spain

Portugal n.a. n.a. n.a.

Austria n.a. n.a. n.a.

Finland n.a. n.a. n.a.

Sweden n.a. n.a. n.a.

Czech Republic n.a. n.a. n.a.

Cyprus n.a. n.a. n.a.

Slovakia n.a. n.a. n.a.

Slovenia n.a. n.a. n.a.

Estonia n.a. n.a. n.a.

Hungary n.a. n.a. n.a.

Latvia n.a. n.a. n.a.

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Country Commercialization Sales Nº of patients

Date Volume reacted in SARS

Lithuania n.a. n.a. n.a.

Malt n.a. n.a. n.a.

Poland n.a. n.a. n.a.

Bulgary n.a. n.a. n.a.

Romania n.a. n.a. n.a.

Croatia n.a. n.a. n.a.

Andorra n.a. n.a. n.a.

Armenia n.a. n.a. n.a.

Azerbaijan n.a. n.a. n.a.

Belarus n.a. n.a. n.a.

Vatican City n.a. n.a. n.a.

Georgia n.a. n.a. n.a.

Iceland n.a. n.a. n.a.

Liechtenstein n.a. n.a. n.a.

Moldova n.a. n.a. n.a.

Monaco n.a. n.a. n.a.

Norway n.a. n.a. n.a.

Russia n.a. n.a. n.a.

San Marino n.a. n.a. n.a.

Switzerland n.a. n.a. n.a.

Ukraine n.a. n.a. n.a.

Total EU/EEA
* This table includes details only on those countries of the EU/EEA where the product has been sold during the reporting period. Countries
with zero (0) sales have been deleted.

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2.3 Overview of exposure and safety data

2.3.1 Actions taken in the reporting interval for safety reasons

(This section should include a description of significant actions (and reasons for these actions) related
to safety that have been taken worldwide during the interval, related to either investigational uses or
marketing experience by the legal Manufacturer, sponsors of clinical trial(s), data monitoring
committees, ethics committees or competent authorities).

2.3.2 Reference safety information changes

(This section should highlight what Reference Safety Information is used by the legal manufacturer
and the date of the current version.
The changes made during the reporting interval to the Reference Safety Information should be
summarised.
The RMS should briefly comment whether any proposals by MAHs in terms of new safety information
and key risk minimisation recommendations has been made based on the evaluation of the
information provided in the PSUR).

2.3.3 Findings from Clinical Trials and other sources

(This section should provide a brief summary of the clinically important emerging safety and efficacy
findings obtained during the reporting interval from:
 Completed clinical trials, ongoing clinical trials, long-term follow-up, other therapeutic use of
medicinal product and new safety data related to fixed combination therapies,
 non-interventional studies,
 Other clinical trial/study,
 Non-clinical data, and Literature,
 Other periodic reports,
 Medication errors).

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2.3.4 Lack of efficacy

(This section should summarize data from post-market surveillance and clinical trials indicating lack
of efficacy, or lack of efficacy relative to established therapy(ies)).

2.4 Clinical Data review

Comparison over time of the ratio of patients reported for <SARs, lack of expected efficacy> during a
period to the amount of product sold by period <and by year, if data is available>:

Period PSUR 1 PSUR 2

2019 2020 2021 2022

Number of Patients <reacting, experiencing lack of

efficacy> during the period

<Number of products sold during period, sales volume>

(<insert sort e.g. desktop, belt, power supply)

Ratio (Number of patients | Number of products)

* Sales volume only where it is not feasible to estimate the number of products. Every attempt should be made to estimate the products
sold.

Report count of serious and non-serious suspected adverse reactions reports received during the
period. This table excludes reports of lack of expected efficacy:

Use of product Category of population Number of reports

Serious Non-Serious Total

As recommended <Target population>

Off label use <Non-target population>

Unknown use <Target population>

Total All

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Number and nature of suspected adverse reactions in any patients received during the PSUR period
(report, patient and mortality count):

Reports Community (EU/EEA) Third Countries (Non-EU/EEA)

Reports Nº of reported Deaths Reports Nº of reported Deaths

(N) Patients (N) (N) (N) Patients (N) (N)

Target populations

Used as
recommended

Off label use

Unknown use

Non-target
Populations

Total

Event count of clinical signs reported as <Serious, Serious unexpected, Non-serious unexpected
(unlisted)> adverse reactions by populations:

Populations Clinical Sign Number of Events*

* Number of times the clinical sign was reported (i.e. occurrences, citations, occasions etc.)

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3. Risk Evaluation

3.1 Evaluation of risks and new information

(This sub-section should assess the critical appraisal provided by the legal manufacturer of new
information relevant to previously recognised risks. The aim is to provide new information (e.g.
information arising from studies to further characterise an important potential risk) and not to present
all the information related to the list of safety concerns.

Where new risks are identified, there should be consideration of whether these might be classified as
‘important’ or ‘other’ risks and whether any action (e.g. update of product information) is warranted).

3.2 Characterization of risks

(This section should reflect a characterisation of the important identified and/or potential risks for the
product based on cumulative data (i.e. not solely based on information received during the reporting
period) and also describe important missing information associated with the use of the product.

Based on information arising from the evaluation period (e.g. successful risk minimisation measures
in place), the legal manufacturer may propose changes to the list of safety concerns. When an
important risk or missing information is re-classified or removed, a justification should be provided in
this section as well as a proposal to update the Risk Management Process accordingly.

If no changes are identified, it is sufficient to state that the safety concerns remain unchanged (e.g. if
the information on the risks has only been updated with most recent data with no consequence on the
known safety profile).

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4. Benefit-Risk balance

The main objective of a PSUR is to present a comprehensive, concise and critical analysis of the
benefit/risk balance of the medicinal product taking into account new or emerging information in the
context of cumulative experience with the use of the medicine, its place in therapeutics and whether
this information affects the overall benefit/risk balance of the product. The PSUR is therefore a tool
for post-authorisation evaluation at defined time points in the lifecycle of a product.

This section should represent the views of the RMS on the benefit-risk balance of the medicinal
product, taking into account data presented in the PSUR and the arguments put forward by the MAH(s)
in the section “Integrated Benefit-risk Analysis for Approved Indications” of the submitted PSUR(s).
Separate benefit-risk evaluations should be provided for each indication of the medicinal products
authorised in more than one indication.

If no new safety concerns or change in benefits have been identified in the PSUR assessment, this
section should be concise (i.e. to indicate that the benefit-risk balance remains unchanged).

In case a full appraisal of the benefit-risk is warranted based on important safety concerns and/or
change of benefits during the reporting interval period, the benefit/risk evaluation should be presented
in a structured manner (i.e. Beneficial effects and uncertainty in the knowledge about the beneficial
effects, Unfavourable effects and Uncertainty in the knowledge about the unfavourable effects,
followed by the balance in line with other assessment report templates).

General guidance on how to describe the benefit-risk assessment:

• Do not repeat results extensively, these are described in detail elsewhere. Just mention the
conclusions, i.e., which are the key favourable/unfavourable effects that have been observed.
Avoid that this section becomes the “summary of the summary”. For products approved for more
than one indication, benefit-risk profiles should be evaluated and presented for each indication
individually. If there are important differences in the benefit-risk balance among populations
within an indication, benefit-risk evaluation should be presented by population, if possible.
• The key benefits and risks considered in the evaluation should be specified since not all benefits
and risks contribute importantly to the overall benefit-risk evaluation. The information presented
in the previous benefit and risk sections should be carried forward for integration in the benefit-
risk evaluation.

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• The strengths, weaknesses, and uncertainties of the evidence should be considered when
formulating the benefit-risk evaluation. Describe how uncertainties in the benefits and risks
impact the evaluation.
• Discuss the need for further studies or need for restrictions to product availability or usage, or
any other conditions or measures aiming to improve the benefit-risk balance and reasoning for
these measures.
• Conclude on the overall “benefit-risk balance” for the active substance and if necessary, for
different indications.
• Discuss the need for changes to the frequency of PSUR submission.
• Consider if the substance is under the additional monitoring list and if any changes are warranted
on that respect.

4.1 Recommendations on benefit-risk balance

(The Recommendation should be based on the current PSUR data and not on other information
related to the medical device but not submitted within the ongoing procedure. Please use section 6
“Other Considerations” to reflect important issues which are unrelated to the current PSUR.)

[In case of recommendation to maintain the marketing authorisation]

Based on the review of data on safety and efficacy the Risk Management Report considers that the
risk-benefit balance of <name of product> medical device remains unchanged and therefore
recommends the maintenance of the marketing authorisation.

[In case of recommendation to vary the marketing authorisation]

Based on the review of data on safety and efficacy the Risk Management Report considers that the
risk-benefit balance of <name of product> medical device remains unchanged but recommends that
the terms of the marketing authorisation(s) should be varied as follows:

[Where the product is involved in a referral procedure, the following statement should be added as
part of the Recommendation section:]
<This recommendation is without prejudice to the final conclusions of the ongoing referral procedure
under ISO 13485:2016 for [name of procedure].>

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[The scope of changes and Package leaflets should be highlighted here. Please do not change the
layout and style of the next section and use the proposed way to highlight changes].

[In case of recommendation to suspend/revoke the marketing authorisation]

Based on the review of data on safety and efficacy the Risk Management Report considers that the
risk-benefit balance of <name of product> medical device is negative and recommends the
suspension/revocation of the marketing authorisation on the following grounds:
- [Name of Product(s)] is/are harmful,
- [Name of Product(s)] lack(s) therapeutic efficacy,
- The risk-benefit balance of [Name of Product(s)] is not favourable,
- The condition [specify the condition concerned] has not been fulfilled.

5. Assessment conclusions and actions

In this section:
- summarise the assessment conclusions and relevant comments highlighted in the AR. Further
to the receipt of legal manufacturer and Member States comments,
- Start with a very brief overview of the active substance/product(s) and its stage in the lifecycle
(when the product was authorised first, its indication and how extensively it is used).
- Briefly summarise the main safety data that became available, including through signal
evaluation, during the reporting interval and cumulatively.
- Discuss whether the safety profile remains in accordance with the expected or whether risks
have changed. If needed, discuss whether updates of the product information are necessary
as well as risk minimisation activity to address specific safety concern(s).
- The overall conclusion should be whether the Benefit Risk balance remains unchanged.
- Changes in PSUR frequency: Any proposals for changes of the PSUR frequency, and/or scope
of the single assessment procedure, i.e. requirements for generics should be discussed based
on data/information presented in the PSURs. Proposals for any changes should be clearly
justified.
- If it is considered that action needs to be taken with regards to the safety specification in
existing RMPs, this should be included in Section 6 “Other considerations” in order to highlight
the need to request changes to existing RMPs.

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