STANDARDS FOR
BEST PRACTICE
www.bapo.com
The British Association of
Prosthetists and Orthotists
MHRA GUIDANCE
FOR BAPO MEMBERS
STANDARDS FOR
BEST PRACTICE
www.bapo.com
The British Association of
Prosthetists and Orthotists
ROLE AND SCOPE OF PRACTICE OF
THE PROSTHETIST/ORTHOTIST
BAPO STANDARDS FOR BEST PRACTICE 3
1
1.1 Introduction
This Standard explains the role and scope of practice of the Prosthetist/Orthotist as
he/she delivers treatment. As well as the practicing clinician it should also be of
particular interest to the service user, prosthetic/orthotic student, assistant
practitioners,other healthcare professionals and service commissioners
1.2 Statement
The Prosthetist/Orthotist is a regulated, autonomous healthcare professional with a
definitive and unique role: the assessment, design and provision of prosthetic and
orthotic treatments
1.3 Professional Role
The Role of the Prosthetist/Orthotist is to take the lead in the assessment and provision of
prosthetic/orthotic interventions, to effectively supervise Assistants and provide consulting
expertise to medics, other health care workers and service users
In doing so the practitioner will:
1.3.1 Abide by the standards of conduct and
proficiency for Prosthetists/Orthotists
as determined by the Health and Care
Professions Council (HCPC)
1.3.2 Work within the scope of practice as
described in this document
1.3.3 Actively contribute to the promotion of
progress within the profession for the
benefit of the service user
1.3.4 Gain informed consent to treatment
from the service user or their
representative and exercise a
professional duty of care
1.3.5 Be committed to continuing professional
development (CPD) and reflective
practice
1.3.6 Be able to provide upon request a
written CPD profile
1.3.7 Integrate the best available evidence
into their practice
1.3.8 Be aware of current pertinent research
evidence
1.3.9 Contribute to audit, research and
development relevant to the service user
1.3.10 Maintain service user confidentiality
1.3.11 Ensure current competence and
awareness of local clinical risk
management, basic life support, manual
handling, infection control and child
protection
MHRA GUIDANCE APPLICABLE
TO PROSTHETICS & ORTHOTICS
The Medicines and Healthcare Regulatory Agency (MHRA) oversees legislation
and regulation of medical devices on the UK market, including prostheses
and orthoses. It has been appointed as the EU as the UK ‘notified body for
medical devices’.
Prostheses and orthoses are considered ‘general medical devices’ and are
currently covered by ‘The Medical Devices Directive 93/42/EEC’:
https://eur-lex.europa.eu/LexUriServ/LexUriServdo?uri= CONSLEG:
1993L0042:20071011:EN:PDF
In 2017 new regulation was set out - ‘The EU regulations on Medical Devices
2017/745’ which will come into full effect by May 2020. An interactive tool has
been launched by MHRA to help clarify aspects in preparation for this change:
https://assets.publishing.service.gov.uk/government/uploads/system/
uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf
The MHRA have also outset how medical devices will be regulated in a no deal
Brexit scenario:
https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-
of-a-no-deal-scenario
Further MHRA publications provide greater detail on certain aspects which
may be relevant to those working in the Prosthetic and Orthotic industry,
these are outset in the pages which follow.
NB: BAPO advise members to contact MHRA directly if they have uncertainty
on their compliance with these regulations or if they require further clarity on
legislation.
It is important to note that regional health boards and local hospital trusts
may have their additional guidance or best practice statements for use of
medical devices, such as publications by Health Services Scotland. BAPO
members should adhere to these where applicable.
GUIDANCE FOR BAPO MEMBERS
2
ALERTS AND RECALLS OF MEDICAL DEVICES
• MHRA publish a weekly industry wide lists of field safety notices with links
to further detail from manufacturer.
• https://www.gov.uk/drug-device-alerts
CLASSIFICATION OF MEDICAL DEVICES
• Most prostheses and orthoses are identified as ‘class 1’ medical devices,
these are regarded as low risk medical devices. Some externally powered
devices may be categorised as ‘class 2a’ ‘class 2b’ and are regarded
as medium risk medical devices. This document outsets the logic for
determining the class of a medical device
• http://ec.europa.eu/DocsRoom/documents/10337/attachments/1/
translations
CONFORMITY ASSESSMENT AND THE CE MARK
• Manufactures need to demonstrate that the medical device meets the
requirements as set out in the ‘Medical Devices Directive’. The assessment
route depends upon the classification of the device (as per above). This
guidance outsets the various assessments routes for devices.
• https://www.gov.uk/guidance/medical-devices-conformity-
assessment-and-the-ce-mark
CUSTOM MADE DEVICES
• This guidance discusses prescription, conformity, labelling, CE marking,
compliance statements, retention of documentation and post-supply
surveillance of devices.
• https://assets.publishing.service.gov.uk/government/uploads/system/
uploads/attachment_data/file/398428/Custom_made_devices.pdf
• https://assets.publishing.service.gov.uk/government/uploads/system/
uploads/attachment_data/file/398323/Examples_of_statements_for_
custom-made_medical_devices.pdf
GUIDANCE FOR BAPO MEMBERS
3
EXCEPTIONAL USE OF NON-CE MARKED MEDICAL DEVICES
• Covers how a manufacturer and clinician can jointly apply for approval to
supply a non-compliant medical device on humanitarian grounds.
• https://www.gov.uk/guidance/exceptional-use-of-non-ce-marked-
medical-devices#criteria-for-exceptional-use-of-non-complying-
medical-devices
EXPORT MEDICAL DEVICES
• You don’t need a certificate of free sale to move medical devices within
the EU. Outside the EU, you may need a Certificate of free sale to export
medical devices. This guidance outlines the application process.
• https://www.gov.uk/guidance/export-medical-devices-special-rules
DEVICES IN PRACTICE
• This is a checklist outlaying detail that should be considered before, during
and after device use. It also outlines responsibility of the users and carers,
record keeping and reporting of problems.
• https://www.gov.uk/government/publications/devices-in-practice-
checklists-for-using-medical-devices
GUIDANCE FOR MANUFACTURERS ON VIGILANCE
• Information for manufacturers of medical devices about reporting adverse
incidents and corrective actions to the MHRA.
• https://www.gov.uk/government/collections/medical-devices-
guidance-for-manufacturers-on-vigilance
GUIDANCE FOR BAPO MEMBERS
4
IN-HOUSE MANUFACTURE OF MEDICAL DEVICES
• In-house manufacture refers to medical devices that are made in a
healthcare establishment to be used for patients within that establishment.
A healthcare establishment is a body that provides care for patients and
promotes public health (eg an NHS hospital).
• This guideline covers legal requirements, exemptions from regulations,
transfer of devices between hospitals, clinical investigations and R&D.
• https://www.gov.uk/government/publications/in-house-manufacture-
of-medical-devices/in-house-manufacture-of-medical-devices
• This guideline covers legal requirements, exemptions from regulations,
transfer of devices between hospitals, clinical investigations and R&D.
• https://www.gov.uk/government/consultations/health-institution-
exemption-for-ivdrmdr
MANAGING MEDICAL DEVICES
• The MHRA produce guidance for managing reusable medical devices.
These covers acquiring devices, training, maintenance & repair, reporting
adverse incidents, decontamination and decommissioning/dispoal.
• https://www.gov.uk/government/publications/managing-medical-
devices#history
NOTIFYING MHRA ABOUT A CLINICAL INVESTIGATION FOR A
MEDICAL DEVICE
• You may need to carry out a clinical investigation as part of the process to
obtain a CE marking for your medical device. You must inform MHRA if you
are planning to do this at least 60 days before starting your investigation.
• https://www.gov.uk/guidance/notify-mhra-about-a-clinical-
investigation-for-a-medical-device
GUIDANCE FOR BAPO MEMBERS
5
OFF-LABEL USE OF A MEDICAL DEVICE
• Medical devices are intended to be used as set out in manufacturer’s
instructions. If using the device in any other way, this is considered ‘off-
label use’.
• This guidance covers medical devices without a CE mark, modifying medical
devices, risk assessment and third-party accessories.
• https://www.gov.uk/government/publications/medical-devices-off-
label-use/off-label-use-of-a-medical-device
PARALLEL IMPORTS OF MEDICAL DEVICES
• If you want to put a medical device which is already marketed in an
EU country on the market in another EU country not intended by the
manufacturer this is a parallel import.
• https://www.gov.uk/government/publications/parallel-imports-of-
medical-devices/parallel-imports-of-medical-devices
REGISTER AS A MANUFACTURER TO SELL MEDICAL DEVICES
• If you place certain medical devices on the EU market you or your
designated authorised representative must register with the MHRA.
• https://www.gov.uk/guidance/register-as-a-manufacturer-to-sell-
medical-devices
SOFTWARE APPLICATIONS
• Guidance is provided on when software applications are a medical device
and how these are regulated.
• https://www.gov.uk/government/publications/medical-devices-
software-applications-apps
GUIDANCE FOR BAPO MEMBERS
6
‘VIRTUAL’ MANUFACTURERS (PREVIOUSLY KNOWN AS ‘OWN
BRAND LABELLING’)
• A virtual manufacturer is an organisation that fully sources its own
named product from another company (sometimes known as the ‘original
equipment manufacturer’), which has designed and manufactured an
identical CE marked product. By placing their own name and address on
the product, the virtual manufacturer takes on the legal responsibilities
for the medical device and is therefore regarded as the manufacturer in
accordance with the medical device regulations. Note that in practice there
is no difference in the regulatory requirements applying to a manufacturer
and a virtual manufacturer.
• This guidance discusses responsibilities of the ‘virtual’ manufacturer,
technical documentation, contractual agreements, CE marking and
distributor status.
• https://www.gov.uk/government/publications/medical-devices-
virtual-manufacturing-replaces-own-brand-labelling
GUIDANCE FOR BAPO MEMBERS
7
www.bapo.com
Review Date: May 2018.
Next Review date: May 2020
www.bapo.com
Review Date: May 2018.
Next Review date: May 2020
www.bapo.com
Review Date: May 2018.
Next Review date: May 2020
Review Date: July 2019
Next Review Date: July 2021
