Comparison of the annexes of the

European Medical Devices

Directive (93/42/EEC) and the
Medical Devices Regulation ((EU)
2017/745)
Eamonn Hoxey

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Background to changes
The MDR is significantly more comprehensive and detailed compared to the MDD. While the MDD
comprises 23 Articles and 12 annexes over 60 pages, the MDR has 123 articles and 17 annexes over 175
pages. This table provides a comparison of some of the annexes of the MDD and MDR.

The table is an excerpt from the MDR/IVDR Smart Support available in Compliance Navigator.

Medical Devices Directive Medical Devices Regulation

Topic Comments
(93/42/EEC), as amended ((EU) 2017/745)

Product Annex I Annex I Where there are 13 ERs in the MDD

requirements The MDD sets out 13 essential The MDR sets out 23 GSPRs (and 16 in the AIMDD), there are 23
requirements (ERs) covering: covering: GSPRs in the MDR. The overall text
and requirements are expanded,
General requirements, General requirements, but the scope and topics are
principally regarding risk; principally regarding risk; consistent overall with the MDD.
Chemical, physical and Products without a medical Some topics such as clinical
biological properties; purpose; evaluation and medicinal
consultation have moved from the
Infection and microbial Chemical, physical and requirements list into the articles,
contamination; biological properties; while other topics are new to the
Construction and Infection and microbial requirements list, including devices
environmental properties; contamination; without a medical purpose and
devices used by lay persons. A
number of areas now have
Devices with a measuring Devices incorporating a increased emphasis and more
function; medicinal product;

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 Medical Devices Directive Medical Devices Regulation
Topic Comments
(93/42/EEC), as amended ((EU) 2017/745)

Protection against Devices with substances that explicit

radiation; are absorbed or locally requirements, such as electronic
dispersed, programmable systems,
Active devices; and nanomaterials, devices with
Devices incorporating substances that are absorbed or
Information supplied by the materials of biological origin; locally dispersed, and substances
manufacturer.
Construction of devices; that are carcinogenic, mutagenic or
endocrine-disrupting. The format of
Interaction with the several of the GSPRSs highlights
environment; aspects to be addressed in the
manufacturer’s risk management
Devices with a diagnostic or
processes.
measuring function;
The section on information to be
Protection against radiation; provided with the device has
increased detail.
Electronic programmable
For further information, see BSI
systems;
White paper ‘General Safety and
Active devices and devices Performance Requirements (Annex
connected to them; 1) in the New Medical Device
Regulation – Comparison with the
AIMDs;
Essential Requirements of the
Mechanical and thermal risks; Medical Device Directive and Active
Implantable Device Directive’ and
Devices supplying energy or BSI Compliance Navigator Blog
substances; ‘Will you need more space on your
Devices for use by lay persons; labels?’.
and,

Information supplied with the

device.

Declaration The conformity assessment Annex IV The declaration of conformity is

of conformity annexes of the MDD indicate that The content of the EU declaration the legal document in which the
the manufacturer has to draw up a of conformity are specified as: manufacturer declares that the
written declaration of conformity. product is in conformance to the
This declaration has to Details of the manufacturer, requirements of the legislation. It
cover one or more medical devices and, if applicable, its is referred to in all the conformity
manufactured, clearly identified by authorised representative; assessment routes in the MDD but
means of product name, product the content is not specified in
Statement that the EU
code or other unambiguous detail. In the MDR, the content of
declaration of conformity is
reference. The declaration of the declaration of conformity is set
responsibility of the
conformity has to be out.
manufacturer;
kept by the manufacturer for the
same period as the technical Product description and
documentation. intended purpose;

Device identifiers of the UDI;

Risk class of the device;

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 Medical Devices Directive Medical Devices Regulation
Topic Comments
(93/42/EEC), as amended ((EU) 2017/745)

A statement that the device

covered by the declaration is
in conformity;

References to any CS used;

Where applicable, the

notified body, and conformity
assessment procedure
performed;

Identification of any
applicable certificate(s);

Signature, place and date of

issue of the declaration with
name and function of the
signatory and for whom it
was signed.

Disclaimer
This guidance is commissioned text from expert authorities in their industry. It has been commissioned, edited and peer-reviewed before
publication but remains the personal opinion of the individual experts who have provided it and it does not provide definitive advice on
matters concerning the law; you should always consult your legal advisors on these matters. It is not official British Standards guidance.
Accordingly, BSI cannot accept liability for any direct or indirect loss or damage arising from a reliance on the commentary except to the
extent that such liability may not be excluded by law.

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Get in Touch
Smart Support is designed to outline the impact of the new regulatory changes, in
order for your business to prepare to navigate the transition and implement the new
requirements.

To access the full comparison table of the annexes of the MDD

and MDR as part of the MDR/IVDR Smart Support series and find
out more about Compliance Navigator, contact us today.

T: +44 (0)20 8996 7029

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