An introductory guide to the medical device regulation (MDR)

and the in vitro diagnostic medical device regulation (IVDR)

mhra.gov.uk

devices.implementation@mhra.gov.uk

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 Introduction - How to use this guide

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 Introduction

2017 2018 2019 2020 2021 2022

3 year transition period

EU MDR EU MDR
Formal implementation
publication

5 year transition period

EU IVDR EU IVDR
Formal implementation
publication

These Regulations entered into force on 25th May 2017.

However, most requirements will not fully apply until 26th

May 2020 for Medical Devices, and 26th May 2022 for In
Vitro Diagnostic Medical Devices.

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 Definitions - Medical Device

Medical Device
Examples:
• dental and surgical instruments
• bandages and splints
• treatment chairs and hospital beds

Definition*:
‘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.

*A full definition can be found in Article 2(1) of the MDR.

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 Definitions - In Vitro Diagnostic Medical Device

In Vitro Diagnostic Medical Device

Examples:
• pregnancy tests
• blood glucose monitors

Definition*:
‘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.

*A full definition can be found in Article 2(2) of the IVDR

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 Definitions - Borderline Products

Borderline Products
Examples:
• Medicated surgical dressings (medical device or medicinal product
depending on manufacturer’s claim)
• Head lice products (medical device or medicinal product depending
on their mode of action)

Some products are hard to distinguish from a medicine or a medical

device. These products are called borderline products until their status
has been decided.

MHRA determines whether a product falls within the definition of a

medicine – ‘medicinal product’ – or a medical device and provides
information on whether a product is a medicine or a medical device or
not.

For more information, please visit our website

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 Definitions - Aesthetic Products

Aesthetic Products
Examples:
• Non-corrective contact lenses
• Equipment for liposuction
• Equipment intended for brain stimulation

Definition:
Annex XVI of the MDR lists out groups of products without an intended
medical purpose, which will now be regulated as medical devices

Manufacturers of products listed in Annex XVI of the MDR shall comply

with the relevant common specifications* for those products.

*These common specifications are expected to be published by the

Commission by 26th May 2020

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 Classification

Classification is based on risk, as set out in Annex VIII of the MDR and
Annex VII of the IVDR.

Manufacturers need to demonstrate that their medical device meets the

requirements in the MRD or IVDR by carrying out a conformity assessment.
The assessment route depends on the classification of the device.

The risk class determines whether or not a conformity assessment would

be required (which is done by a Notified Body).

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 Classification

Medical Devices In Vitro Diagnostic

Medical Devices

High risk Examples: Examples:

Pacemakers Hepatitis B blood-donor
Heart valves screening
Implanted cerebral Class III Class D HIV blood diagnostic test,;
simulators ABO blood grouping

Examples: Examples:
Condoms Blood glucose self-testing
Notified Body Lung ventilators PSA screening;
Bone fixation plate Class IIb Class C HLA typing
Increasing risk

approval required

Examples: Examples:
Dental fillings Pregnancy self-testing
Surgical clamps Urine test strips
Tracheotomy tubes Class IIa Class B Cholesterol self-testing

Examples: Class I medical devices Examples:

Wheelchairs will require involvement Clinical chemistry analysers
of a Notified Body if
Self-assessment Stethoscopes
Spectacles Class I
they are sterile, have a
measuring function or Class A
Specimen receptacles;
Prepared selective culture
are re-usable media
surgical instruments.

Low risk

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 Classification - Conformity assessment

Conformity assessment

Manufacturers need to demonstrate that the medical device meets the requirements in the
MDR or IVDR by carrying out a conformity assessment. The assessment route depends
on the classification of the device.

Manufacturers can place a CE mark on the product to show that the medical device has
met the requirements when it has passed the conformity assessment.

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 Classification - Conformity assessment

Medical Devices In Vitro Diagnostic

Medical Devices
Which classes of products
High risk
require conformity assessment
Class III Class D by a notified body?
Approval is required for Class IIa, IIb and
III medical devices and Class B, C and D in
vitro diagnostic devices.
Notified Body
Class IIb Class C
Increasing risk

approval required Some Class I and Class A devices will

require notified body approval for parts of
the manufacturing process that relates to
sterility or metrology, if the medical device
includes sterile products or a measuring
Class IIa Class B function.

Manufacturers can certify their products

with any notified body within the EU.

Self-assessment Class I Class A

Low risk

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 Classification - Notified Body

Medical Devices In Vitro Diagnostic

Medical Devices
Notified Body
High risk

Class III Class D

Notified bodies are independent certification
bodies designated by national Competent
Authority (i.e. MHRA). They perform third-
party conformity assessment activities
Notified Body including calibration, testing, certification
Class IIb Class C and inspection.
Increasing risk

approval required

A list of active notified bodies can be found

on NANDO.

Class IIa Class B

Self-assessment Class I Class A

Low risk

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 Conformity assessment

What requirements do I need to meet for a conformity assessment?

1. General Safety and Performance Requirements (Annex I of the MDR and IVDR):

• Benefits must outweigh risks and achieve the claimed performance - This must be
proven with supporting clinical evidence and investigation
• Chemical, physical and biological properties for medical devices
• Performance characteristics for in vitro diagnostic medical devices
• Information supplied by the manufacturer with the device - For example, instructions for
use. It is important that devices are labelled correctly

2. Technical documentation (Annex II of the MDR and IVDR)

3. Harmonised standards / common specifications (Articles 8 and 9 of the MDR and IVDR)

Please see Annex IX, X and XI of the MDR and the IVDR for more information.

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 Conformity assessment

In what instances can I place a device on the market without

undertaking an assessment of conformity?

In certain circumstances, a Competent Authority may authorise the placing on the market
or putting into service a specific device that has not carried out the procedures referred to
in Article 52 of the MDR or Article 48 of the IVDR.

This can happen in circumstances that are in the interest of public health or patient safety
or health.

See Article 59 of the MDR and Article 54 of the IVDR for more information on when you
can derogate from the conformity assessment procedures.

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 Placing a device on the market

Pass
1. Pass a conformity assessment
Fail
This does not apply to most Class I medical devices and Class A in vitro diagnostic devices

2. Draw up a declaration of conformity (Annex IV of the MDR and IVDR)

3. Place a CE mark on the device

CE marks are not unique to medical devices

4. Assign a Basic UDI-DI and provide it to the UDI database

For devices other than custom-made devices

5. Submit key information about the manufacturer, and authorised

representative and importer if applicable, to the electronic system (Eudamed)
For devices other than custom-made devices

6. Place your CE marked device anywhere in Europe or put your

device into service

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 UDI and Eudamed

The UDI system provides a consistent and standard way to identify medical devices throughout their
distribution and use by health care providers and patients. Most devices will be required to have a UDI
on their label and packaging, and for certain devices, on the product itself.

‘Unique Device Identifier’ (‘UDI’) is a series of numbers that enables for the tracing of the manufacturer,
device (UDI-DI number) and the unit of device production (UDI-PI number).

UDIs will be phased in over several years, starting with the highest risk devices, such as heart valves
and pacemakers.

See Article 27 of the MDR and Article 24 of the IVDR for more information.

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 UDI and Eudamed

The European databank on medical devices (Eudamed), is a database that those who manufacture
and supply medical devices, as well as Notified Bodies, health institutions and Competent Authorities,
will have access to.

Using this system, those involved in manufacturing and supplying medical devices and IVDs will
need to register their organisation and devices, upload relevant documentation, apply for clinical
investigations and performance studies, and upload post-market surveillance documentation.

Eudamed is currently being overhauled for the new regulations to increase capabilities and allow wider
access.

See Article 30* of the MDR and Article 27* of the IVDR for more information.

*These requirements will not apply if the necessary improvements to the Eudamed
database are not completed on time.

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 Supply chain obligations

“I’m a manufacturer” “I’m an importer”

“I’m an authorised “I’m a distributor”

representative”

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 Supply chain obligations - Manufacturer

Manufacturer
Definition:
‘Manufacturer’ means a natural or legal person who manufactures or fully
refurbishes a device or has a device designed, manufactured or fully refurbished,
and markets that device under its name or trademark.

Obligations:
Manufacturers will have a number of additional obligations, including:
• Having at least one person responsible for regulatory compliance;
• Ensuring that sufficient financial coverage is in place;
• Ensuring that quality management systems meet the more stringent
requirements.

For more details, see Article 10 of the MDR and the IVDR.

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 Supply chain obligations - Authorised representative

Authorised representative
Definition:
‘Authorised representative’ means any natural or legal person established within
the Union who has received and accepted a written mandate from a manufacturer,
located outside the Union, to act on the manufacturer’s behalf in relation to specified
tasks with regard to the latter’s obligations under this Regulation.

Obligations:
Authorised representatives will have a number of additional obligations, including:
• Having at least one person responsible for regulatory compliance;
• Where the manufacturer is not established in a Member State and has not
complied its obligations, the authorised representative shall be legally liable
for defective devices on the same basis as, and jointly and severally with, the
manufacturer, and will need to ensure that sufficient financial coverage is in place.

For more details, see Article 11 of the MDR and Article 12 of the the IVDR.

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 Supply chain obligations - Importer

Importer
Definition:
‘Importer’ means any natural or legal person established within the Union that places
a device from a third country on the Union market.

Obligations:
Importers will have a number of additional obligations, including verifying that:
• The device has been CE marked;
• The manufacturer is identified and it has an authorised representative, if required;
• The device has been labelled correctly and a UDI has been assigned to the
device;
• The device is registered in the electronic system (Eudamed).

For more details, see Article 13 of the MDR and the IVDR.

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 Supply chain obligations - Distributor

Distributor
Definition:
‘Distributor’ means any natural or legal person in the supply chain, other than the
manufacturer or the importer, that makes a device available on the market, up until
the point of putting into service.

Obligations:
Distributors will have a number of additional obligations, including verifying that:
• The device has been CE marked;
• The device is accompanied relevant information to be supplied by the
manufacturer;
• The importer has complied with their general obligations;
• A UDI has been assigned to the device.

For more details, see Article 14 of the MDR and the IVDR.

Devices can also be offered by means of information society services. The

obligations on these distributors are at Article 6 of the MDR and the IVDR.

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 PMS and vigilance - Post-market surveillance requirements

Post-market surveillance requirements (preventative / proactive)

Definition:
‘Post-market surveillance’ means all activities carried out by manufacturers in
cooperation with other economic operators to institute and keep up to date a
systematic procedure to proactively collect and review experience gained from devices
they place on the market, make available on the market or put into service for the
purpose of identifying any need to immediately apply any necessary corrective or
preventive actions.

Key obligations:
• Ensure ongoing safety of device – appropriate/risk benefit balance
• Inform development of future iterations of the device
• Conduct FSCAs (field safety corrective actions)

Field safety corrective actions are corrective actions taken by a manufacturer for
technical or medical reasons to prevent or reduce the risk of a serious incident in
relation to a device made available on the market.

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 PMS and vigilance - Post-market surveillance requirements

Post-market surveillance requirements (preventative / proactive)

New features of the Regulations:

• PSURs - Periodic Safety Summary Report: Summarises the results and conclusions
of the analyses of the post-market surveillance data. See Article 86 of the MDR and
Article 81 of the IVDR
• PMCF / PMPF - Post-Market Clinical / Performance Follow-Up: A continuous process
that updates the clinical / performance evaluation. See Annex XIV, Part B of the MDR
and Annex XIII, Part B of the IVDR
• Other post-market studies

See Chapter VII, Section 1 of the MDR and IVDR for more information.

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 PMS and vigilance - Vigilance requirements (reactive)

Vigilance requirements (reactive)

Key obligations:
• Reporting of serious incidents
• Voluntary and mandatory reporting
• Trend reporting

See Chapter VII, Section 2 of the MDR and IVDR for more information.

Serious incidents
A serious incident means any incident that directly or indirectly led, might have led or
might lead to any of the following:

• the death of a patient, user or other person

• the temporary or permanent serious deterioration of a patient’s, user’s or other
person’s state of health
• a serious public health threat

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 PMS and vigilance - Market surveillance

Market surveillance
Definition:
‘Market surveillance’ means the activities carried out and measures taken by
competent authorities to check and ensure that devices comply with the requirements
set out in the relevant Union harmonisation legislation and do not endanger health,
safety or any other aspect of public interest protection.

See Chapter VII, Section 3 of the MDR and IVDR for more information.

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 Contact us

mhra.gov.uk devices.implementation@mhra.gov.uk

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