Adverse event reporting ABPI UK

1. Date:
File Reference:
xx/xx/xx
xxxxxx
Adverse Event Reporting
Medical Device Update
18 March 2021
m

2. Belen Granell Villen
ABPI Quality and Safety Policy Executive
Camille Bach
Novartis UK Patient Safety Senior Specialist
AE/PC/SRS Guidelines Update
Catherine Ayland
BHBIA Ethics Advisor
Yuliya Fontanetti
BHBIA Ethics & Compliance
Committee Deputy Chair, Global
Director of Project Management and
Compliance, Cello Health Insight

3. Our goal is to explain the changes to the joint
BHBIA and ABPI AE/PC/SRS Guidance Notes on
collecting AEs/PCs/SRSs during market research
brought about by the UK Medicines and
Medical Devices Act 2021
AE/PC/SRS Guidelines Update

4. Why the guidance has been updated
Belen Granell Villen
Explanation of the changes
Catherine Ayland
Practical implications – company perspective
Camille Bach
Practical implications – agency perspective
Yuliya Fontanetti
Questions & Answers
AE/PC/SRS Guidelines Update

5. Why the guidance has been updated
Belen Granell Villen
AE/PC/SRS Guidelines Update

6. Changes to MD law EU & UK
AE/PC/SRS Guidelines Update

7. Medical Devices Law UK & EU
• 26th May 2020 a new EU Med Devices Regulation was due to come into effect
• Full name: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and
repealing Council Directives 90/385/EEC and 93/42/EEC https://eur-lex.europa.eu/eli/reg/2017/745/oj
• Of relevance 2 recitals (46 & 79) and chapter III (Other obligations of the sponsor)
• And Covid-19 crisis arrived . . .

8. Medical Devices Law UK & EU
• 25th March 2020 the European Commission - proposal to postpone the date of application for the
new EU Medical Devices Regulation for one year
• UK MDR would come into effect prior to the EU MDR
• BHBIA & ABPI considered whether to delay the update or not

9. MHRA Guidance for
Northern Ireland & Great Britain
AE/PC/SRS Guidelines Update

10. MHRA Guidance for Northern Ireland
• From 1 January 2021 MHRA will continue to act as Competent Authority for medical devices in NI
• NI Protocol & the rules for placing medical devices on the NI market
• MDR will apply in NI from 26 May 2021 and the IVDR will apply from 26 May 2022, in line with the
EU’s implementation timeline
• Source links:
• MHRA Guidance: Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
• How to place a MD on NI market from 1 Jan 2021, please read here, or for GB read here.
• Legislation: here.

11. MHRA Guidance for Great Britain
• GB route to market from 1 January 2021 – still based on EU legislation however there have been some
changes introduced through secondary legislation to how medical devices are placed on the market in GB
• EU MDR and EU IVDR did not take effect during transition period,
not EU law automatically retained by EU Withdrawal Agreement Act
• Source links:
• MHRA Guidance: Regulating medical devices in UK
• How to place a MD on GB market from 1 Jan 2021, please read here.
• Legislation: Link here

12. MHRA Guidance for GB
• The Independent Medicines and Medical Devices Safety Review (July 2020)
• MHRA commitment to improving the standards of medical devices
• The Medicines and Medical Devices Act 2021

13. UK Medicines & Medical Devices Act 2021
• Royal assent on 11 February 2021
• The Act and legislation can be amended in post Brexit world
• Patient safety has been elevated to Part 1 of Act
• New role: Patient Safety Commissioner
• The Patient Safety Commissioner's duties: promote safety and views of patients
• Medical devices is a key issue

14. • Not all parts are in force immediately
• E.G. provisions relating to Patient Safety Commissioner
and some provisions relating to human medicines and
medical devices in force two months from day on which
Act is passed i.e. 11 April 2021
• Other provisions will be brought into force by statutory
instrument at a date not yet determined
• Many regulations will be subject to public consultation
• Report to Parliament about progress in five years’ time
UK Medicines & Medical Devices Act 2021

15. Timetable
• Introduction of UK Law: Now (MMD Act received Royal
Assent 11 February)
• Introduction of EU MDR: EU MDR and EU IVDR will apply
in NI from 26 May 2021 and 26 May 2022 respectively
• ABPI/BHBIA Guidance: 26 May 2021 (date EU MDR
comes into effect)

16. Medical Devices &
Certificate of Conformity Holders
• Inclusion of medical devices and certificate of conformity holders
• Medical device: Definition lifted from article 2 of the EU MDR
• Certificate of conformity holder: The MDR 2017/745 didn’t quite use the same term,
so we used an amalgamation of different definitions within the regulation
• We also made reference to the UK conformity marks as well as the EU regulation
https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark

17. Explanation of the Changes
Catherine Ayland

18. Definitions
What differences you will see
What remains the same
AE/PC/SRS Guidelines Update

19. Medicinal Product vs Medical Device
• A medicinal product is characterized by any substance or combination of substances;
– presented as having properties for treating or preventing disease in human beings; or
– which may be used in, or administered to human beings either with a view to restoring, correcting or
modifying physiological functions by exerting a pharmacological, immunological or metabolic action,
or to making a medical diagnosis.
• A medical device means any instrument, apparatus, appliance, software, implant, reagent,
material or other article intended by the manufacturer to be used, alone or in combination, for
human beings for specific medical purposes
Article 2 Definitions of the Medical Devices Regulation for further detail
– Software when specifically intended by the manufacturer to be used for a medical purpose qualifies
as a medical device, while software for general purposes, even when used in a healthcare setting, or
software intended for life-style and well-being purposes is not a medical device.

20. Medical Device
• A medical device means any instrument, apparatus, appliance, software, implant, reagent,
material or other article intended by the manufacturer to be used, alone or in combination, for
human beings for specific medical purposes
Article 2 Definitions of the Medical Devices Regulation for further detail
– Including software when specifically intended by the manufacturer to be used for a medical purpose
• In vitro diagnostic medical device means any medical device which is a reagent, reagent
product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or
system, whether used alone or in combination, intended by the manufacturer to be used in
vitro for the examination of specimens, including blood and tissue donations, derived from the
human body, solely or principally for the purpose of providing information
• Products which combine a medicinal product and a medical device

21. Medicinal Product vs Medical Device
Marketing authorisation holder (MAH)
The organisation legally responsible for the quality, efficacy and safety of a medicine or
medicine-medical device
• The MAH may contract a third party to commission the MR agency to carry out the MR, any
reference made to an MAH includes any third party organisations
Certificate of conformity holder
Manufacturer or other body which holds certified documentation from a notified body in line
with UK CA mark or UKNI CE mark requirements or in line with EU regulation 2017/745 on
medical devices

22. 3.2.3 If you become aware of an SRS, you must forward it to the MAH/Certificate Holder, whether or not an AE or PC
is associated with it.
If an SRS relates to a reported use of counterfeit or falsified medicines or devices or tampering, you should
consult with the MAH/Certificate Holder to make sure that the medicines or devices are collected appropriately.
Medicinal Product vs Medical Device
4.1.1 Always forward at least the following (for an individual patient or a group of patients):
• The name of the medicine or medical device concerned
• A description of the AE/PC/SRS experienced
The MAH/Certificate Holder should make available to the MRA a list of relevant medicines or medical devices
for which it holds a Marketing Authorisation /Certificate Holder in the UK including the generic and brand name.

23. AE/PC/SRS Guidelines Update

24. AE/PC/SRS Guidelines Update

25. Brexit & Transfers of Personal Data
From UK to EU
“In recognition of the unprecedented degree of alignment between the
UK and EU’s data protection regimes, the UK would at the point of exit
continue to allow the free flow of personal data from the UK to the EU.”
From EU to UK
• EC issued draft adequacy decisions
– Assuming they’re formally approved
– Unrestricted flow of data between EEEA and UK can continue
– Alternative data transfer mechanisms (such as SSCs) will not be needed

26. What remains largely the same:
– AE/PC/SRS definition
AE/PC/SRS Guidelines Update
Product complaint now contains a
device malfunction
Where it is reasonable to consider there is a causal relationship
between a medicinal product or medical device and an AE (i.e.
that the medicine or device is contributing to causing an AE), and
the response to the medicine or device is noxious and
unintended, the AE is known as an ‘adverse drug reaction’ or an
“adverse incident” in the case of medical devices.

27. What remains the same:
– Collection and reporting process
– Timeframe
– Data protection obligations
AE/PC/SRS Guidelines Update

28. Practical implications – Company perspective
Camille Bach
AE/PC/SRS Guidelines Update

29. Impact on Policies
• Inclusion of the new Medical Devices definition (Regulation (EU) 2017/745 and
2017/746)
• Impact also on Certificate of conformity holder in addition to MAH
– For Medical Devices : Manufacturers/Certificate of conformity holder are
responsible for safety reporting to national Competent Authorities
• Review of the licensing status of products :
– Medical Devices / Medicinal Product / Medical device AND Medicinal Product

30. Impact on Processes
• Update of the processes to include the Medical devices
• Update of market research contract clause wording relating to AE/PC/SRS reporting
requirements to include the Medical devices

31. Impact on Processes
• Update of AE/PC/SRS collection
form to include Medical Devices
and provide this updated form to
the MRA

32. • In an online survey, an HCP MR participant states, “I switched from
Device A to Device B because Device B is better”
– To Report : No
• A nurse reported that one of her patients with diabetes tried to inject his insulin X,
but the pen jammed. Patient injected with another pen. No missed dose
– To Report : Yes - The pen jammed is a PC
Examples

33. Examples
• A nurse reported that one of her patients used inhaler X with
a medication not suitable for inhalation
– To Report : Yes - Device abnormal use (i.e. intentional misuse)
or off-label use leading to Adverse Event or medication error
• During an interview, a MR participant taking Medicine X for diabetes indicates
that she had an issue once with the plunger of drug X delivery system : plunger
gets stuck during use and the patient received only half the dose
– To Report : Yes - Device malfunction or use error leading to medication error, drug
maladministration, or accidental drug exposure

34. Examples
• A nurse reported that one of her patients using injectable drug X had the
following issue : due to an issue with the pen button, the pen was repeatedly
unable to deliver a full dose to the patient, leading to the patient experiencing a
drug withdrawal syndrome/reaction
– To Report : Yes - Drug withdrawal syndrome/reaction explicitly reported as
associated to a device malfunction or use error

35. Examples
• In an online survey, an HCP MR participant states, “I think this patient experienced
an infection which is suspected to have been transmitted through use of the auto
injector X”
– To Report : Yes - Transmission of infectious disease via medical device
• In an online survey, an HCP MR participant states, “A patient treated with Drug X
auto injector had the following issue : the device was delivering an incorrect dose
and the patient experienced overdose”
– To Report : Yes - Overdose associated with medical device malfunction or use
error

36. Examples
• If when carrying out MR for a medical device manufacturer, and a respondent
shares an AE/PC/SRS linked to the use of a medical device manufactured by the
company (e.g. misuse), should we report this as an AE/PC/SRS (although the
sponsor is not the MAH of the drug that is used within the device)?
– To Report : If the AE/PC/SRS is related to use of the device it should be reported
in line with the device manufacturer’s instructions. If the AE/PC/SRS is related
to the drug and not the device then the AE/PC/SRS does not have to be forwarded as
the device manufacturer is not the MAH for the drug (only the device).

37. Practical implications – Agency perspective
Yuliya Fontanetti
AE/PC/SRS Guidelines Update

38. Breaking News!

39. Timeline
Review Communication
Process Monitoring
Review all current processes and
materials in line with updated guidance.
Identify clients who manufacture
devices and inform them of changes if
necessary
Cascade communication to the entire
project chain including: pharma clients
and device manufacturers, internal staff
members, suppliers and subcontractors
(including freelance moderators, coders,
data analysts etc)
Update all internal processes and SOPs
in line with updated guidance, including
updating templates and wording to
include medical devices
Monitor newly created process,
encourage feedback on any issues and
implement changes to process where
necessary

40. Updates and Timing
To update
• Process and Procedures
• Standard wording in materials (screener,
questionnaire etc)
• Reporting/Reconciliation forms
• Contracts with subcontractors (suppliers
and freelancers)
• Product lists
• Contact details for manufacturers
26 May 2021

41. Practical Examples
Example 1
During a market research interview
patient with mild asthma mentions that
inhaler they recently purchased jammed
when inhaling. Device itself does not
belong to MAH sponsoring market
research.
Report: NO
Example 2
In an online survey, a healthcare
professional reports that 50% of his RA
patients had to be switched to an
alternative injectable biologic due to
reports of injection-site reactions.
Report: YES
Example 3
You are undertaking a device testing
project where a manufacturer’s
prototypes are tested. Prototypes are
designed to measure blood glucose
levels in T2D patients. A number of
prototypes used malfunction.
Report: NO

42. Important Considerations
Prior to fieldwork
Understand whether client company, commissioning market research, also manufactures medical
devices that might be mentioned during the course of fieldwork.
Ensure all subcontractors are trained and are aware of any medical devices that might be mentioned.
1
2
3
After fieldwork
Know where to send reports, whether related to medicinal products or medical devices (will there be
different contact details for reporting depending on type of product/device?)
Reconciliations would currently include both medications and devices, similarly to reports – these
might need to be split out. Knowing this early will help accurate reconciliation.
During Fieldwork
Monitor adverse events, product complaints and special reporting situation related to
medicinal products as well as medical devices.
Ensure all reports are appropriately recorded and stored securely. Medical devices can be
mentioned by name, shape/colour or even function.

43. BHBIA Resources
• BHBIA/ABPI guidance notes on collecting
AEs, PCs and SRSs during MR (Updated 2021)
– Medical device certificate of conformity holders
(the equivalent of MAH) in section 1.2
– Medical devices and their definition in section 1.3
– Adding in ‘devices’ and ‘conformity certificate
holders’ throughout the Guidance including
within the Data Collection Form, Reconciliation
Form, Standard Paragraphs and other Annexes
– Updating the list of relevant legislation in section
1.4 and use of these in the footnotes

44. BHBIA - Other Resources
• AE/PC/SRS Data Collection Form
• AE/PC/SRS Reconciliation Form
• Standard Paragraphs to use for reporting
• Adverse Events Reporting Training
• ABPI Guidance Notes