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PRIMARY DENTAL JOURNAL journals.sagepub.com/home/PRD
22
© The Author(s) 2022. Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/20501684221101472
MEDICAL DEVICE
REGULATIONS AND
CUSTOM-MADE DEVICE
DOCUMENTATION: TEN
FREQUENTLY ASKED
QUESTIONS AND THEIR
ANSWERS
1101472PRD Primary Dental JournalMonth xxxx
Prim Dent J. 2022;11(2):22-31
JAMES I.J. GREEN
AUTHOR
James I.J. Green DipSci (Den Tech),
HNCSci (Den Tech), LBIDST, FOTA,
MDTA
Maxillofacial and Dental Laboratory Manager, Great
Ormond Street Hospital for Children NHS Foundation
Trust, London; Broomfield Hospital, Mid and South
Essex NHS Foundation Trust, Chelmsford, UK
AbstrAct
Dental professionals who practice in the UK must follow the General Dental
Council (GDC) Standards, one of which is to “find out about laws and
regulations that affect your work and follow them”. Dental professionals
manufacture custom-made devices (CMDs) and the legislation that governs
these devices has changed. Medical devices manufactured within the
European Union (EU) were previously subject to Council Directive 93/42
/EEC (Medical Devices Directive [MDD]), which was given effect in UK law
by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618
[UK MDR 2002]). Regulation (EU) 2017/745 (Medical Device Regulation
[EU MDR]) was scheduled to replace the MDD on 26 May 2020, but this was
postponed for one year due to the coronavirus (COVID-19) pandemic. In
preparation for the UK’s departure from the EU, the EU MDR was largely
transposed into The Medical Devices (Amendment etc.) (EU Exit) Regulations
2019 (Statutory Instrument 2019/791 [UK MDR 2019]), which amended the
UK MDR 2002, and was expected to come into effect on 1 January 2021 but
a further amendment, The Medical Devices (Amendment etc.) (EU Exit)
Regulations 2020 (Statutory Instrument 2020/1478 [UK MDR 2020]),
removed these provisions. As of 1 January 2021, medical devices in Great
Britain are subject to either the UK MDR 2002 (as amended) or the EU MDR
(until 30 June 2023) while those in Northern Ireland must be manufactured in
accordance with the EU MDR. This paper provides the answers to some key
questions regarding the documentation that must be supplied with CMDs
following these changes.
KEY WORDS
COVID-19, European Union,
international health regulations, medical
device legislation, professionalism
LEARNING OBJECTIVES
•To understand that medical devices
must be accompanied by the relevant
documentation
•To recognise which documentation
obligations relate to custom-made
devices in a dental context
•To appreciate the information that must
be included on custom-made device
documentation from a General Dental
Council (GDC) standpoint
VOL. 11 NO. 2 SUMMER 2022 23
Introduction
Under UK and European Union (EU)
legislation, a medical device that “is
intended for the sole use of a particular
patient” and “specifically made in
accordance with a written prescription”
is known as a custom-made device
(CMD).1 Within dentistry, CMDs include
special trays,2 removable prosthodontic
appliances (dentures3 and obturators),4
fixed prosthodontic restorations (inlays,
onlays, crowns and bridges),5
orthodontic appliances,6-9 bruxism
splints,10 mouthguards,11 speech therapy
appliances,12 and devices that facilitate
orthognathic surgery, such as arch bars
and wafers.13-15
CMDs manufactured within the EU were
previously subject to Council Directive
93/42/EEC, which was commonly
referred to as the Medical Devices
Directive (MDD),16 and later
amendments. In the UK, the MDD was
given effect in law by The Medical
Devices Regulations 2002 (Statutory
Instrument 2002/618 [UK MDR
2002]),17 as well as subsequent
amendments, and enforced in the UK by
the Medicines and Healthcare products
Regulatory Agency (MHRA).18
In the years since the implementation of
the MDD, incidents related to deficient
medical devices, such as breast implants
and metal-on-metal hip replacements,
identified weaknesses in the MDD and
the European Commission decided that
more robust regulations were required.19
This led to the publication of Regulation
(EU) 2017/745 (Medical Device
Regulation [EU MDR])20 which replaced
the MDD and, following a three-year
transitional period, was due to be fully
implemented on 26 May 2020, but was
deferred for one year until 26 May
2021 due to the coronavirus disease
2019 (COVID-19) pandemic.21
The EU MDR was largely transposed into
UK law by the Medical Devices
(Amendment etc.) (EU Exit) Regulations
2019 (Statutory Instrument 2019/791
[UK MDR 2019]),22 which amended the
UK MDR 2002,17 and it was anticipated
that this would come into effect on “exit
day” (which was ultimately 31 January
2020) but instead, the UK entered an
11-month implementation period (IP),
during which the EU legislation
continued to apply.1,19,22 The UK MDR
2002 was further updated by the
Medical Devices (Amendment etc.) (EU
Exit) Regulations 2020 (Statutory
Instrument 2020/1478 [UK MDR
2020]), which essentially removed the
provisions of the EU MDR and substituted
“exit day” for “IP completion day”
(which was 1 January 2021).23
As of 1 January 2021, in Great Britain
(England, Scotland, and Wales), medical
devices must be manufactured in
accordance with either:
•The UK MDR 2002 (as amended) or
•The EU MDR (until 30 June 2023).24
Medical devices manufactured in
Northern Ireland are subject to the EU
MDR (under the terms of the Ireland
/Northern Ireland protocol).24,25
As a consequence of these legislative
changes, the obligations regarding the
documentation that needs to be supplied
with medical devices have been updated.
Dental professionals who prescribe and
manufacture CMDs need to be aware of
these changes. In addition, it is essential
to abide by this legislation from a
General Dental Council (GDC)
standpoint: GDC Standard 1.9 states
“You must find out about laws and
regulations that affect your work and
follow them”.26 This paper sets out ten
frequently asked questions regarding the
changes to the documentation
requirements under the new legislation,
together with their answers.
1. What documentation
needs to be supplied
with custom-made
devices (CMDs)?
Under the MDD, CMDs were required to
be supplied with a statement, label and,
depending on the risk class, instructions
for use.16 This remains the same under
the new legislation but there have been
some changes to the requirements.20
2. What has changed with
regards to the information
that needs to be included
on the statement?
Under the MDD, CMDs need to be
supplied with a statement (MDD Annex
VIII[2.1]). The information that needs to
be included on this statement is as
follows:
•the name and address of the
manufacturer
•data allowing identification of the
device in question
•a statement that the device is intended
for exclusive use by a particular patient,
together with the name of the patient
•the name of the medical practitioner
or other authorized person who made
out the prescription and, where
applicable, the name of the clinic
concerned
•the specific characteristics of the
product as indicated by the
prescription
•a statement that the device in question
conforms to the essential requirements
set out in Annex I and, where
applicable, indicating which essential
requirements have not been fully met,
together with the grounds
— MDD Annex VIII(2.1) (page 17)16
In Great Britain, the information that
needs to be included on the statement
remains as it was under the MDD (UK
MDR 2002 regulation 15).17
Manufacturers in Northern Ireland and
the EU now need to follow the
requirements given in EU MDR Annex
XIII(1),20 which are comparable with
those provided in MDD Annex
VIII(2.1),16 but with the following
changes:
•The names and addresses of any
additional manufacturing sites must
now be included. In the case of a
CMD in a dental setting, the names
and addresses of the prescriber and
the dental professional who constructs
the device need to be included as
they will typically share the role of
manufacturer. In cases where more
than one laboratory is involved – for
instance, where the cobalt chromium
framework for a partial denture is
constructed at one laboratory and the
poly(methyl methacrylate) parts are
fabricated at another – the names
and addresses of both dental
technicians/laboratories would need
to be included on the statement.
•A manufacturer outside the EU or
Northern Ireland who places a device
on the EU or Northern Ireland market
will need to include the name and
address of the authorised
representative.
Primary Dental Journal
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Medical device Regulations and custoM-Made device
docuMentation: ten FaQs and theiR answeRs
•The name of the clinic concerned has
been replaced by the name of the
health institution concerned.
•The statement needs to state that it
conforms to the general safety and
performance requirements set out in
Annex I (of the EU MDR) as opposed
to the essential requirements set out in
Annex I (of the MDD).
•There is also a requirement regarding
devices that contain or incorporate a
medicinal substance, but this does not
relate to CMDs in a dental setting.
Table 1 compares the statement
requirements under the UK MDR 2002
and the EU MDR, indicates the changes
(in bold), and highlights which relate to
CMDs in a dental context.
3. What has changed with
regards to the information
that needs to be included
on the label?
The EU MDR defines a label as the
“written, printed or graphic information
appearing either on the device itself, or
on the packaging of each unit or on the
packaging of multiple devices” (EU MDR
Article 220). Under the MDD, the
requirements regarding the information
that needs to be included on the label
are outlined in Annex I(13.3):
(a) t he name or trade name and
address of the manufacturer. For
devices imported into the
Community [European
Community (EC), a precursor to
the EU], in view of their
distribution in the Community, the
label, or the outer packaging, or
instructions for use, shall contain
in addition the name and
address of the authorised
representative where the
manufacturer does not have a
registered place of business in
the Community
(b) the details strictly necessary to
identify the device and the
contents of the packaging
especially for the users
(c) where appropriate, the word
‘STERILE’
(d) where appropriate, the batch
code, preceded by the word
‘LOT’, or the serial number
(e) where appropriate, an indication
of the date by which the device
TABLE 1
CUSTOM-MADE DEVICE STATEMENT REQUIREMENTS UNDER UK AND EU LEGISLATION
Great Britain Northern Ireland / European Union Applicable to CMDs
in a dental context
MDD Annex VIII(2.1) (page 50)16 EU MDR Annex XIII(1) (page 163)20
the name and address of the manufacturer the name and address of the manufacturer, and of all
manufacturing sites,
Yes
— if applicable, the name and address of the
authorised representative, Yes
data allowing identification of the device in
question
data allowing identification of the device in question, Ye s
a statement that the device is intended for
exclusive use by a particular patient, together
with the name of the patient
a statement that the device is intended for exclusive use by
a particular patient or user, identified by name, an
acronym or a numerical code,
Yes
the name of the medical practitioner or other
authorized person who made out the prescription
and, where applicable, the name of the
clinic concerned
the name of the person who made out the prescription and
who is authorised by national law by virtue of their
professional qualifications to do so, and, where applicable,
the name of the health institution concerned,
Yes
the specific characteristics of the product as
indicated by the prescription
the specific characteristics of the product as indicated by
the prescription,
Yes
a statement that the device in question conforms
to the essential requirements set out in Annex I
and, where applicable, indicating which
essential requirements have not been fully met,
together with the grounds
a statement that the device in question conforms to the
general safety and performance requirements set out
in Annex I and, where applicable, indicating which
general safety and performance requirements have
not been fully met, together with the grounds,
Yes
—where applicable, an indication that the device contains or
incorporates a medicinal substance, including a human blood
or plasma derivative, or tissues or cells of human origin, or of
animal origin as referred to in Regulation (EU) No 722/2012.
No
VOL. 11 NO. 2 SUMMER 2022 25
should be used, in safety,
expressed as the year and month
(f) where appropriate, an indication
that the device is for single use. A
manufacturer’s indication of
single use must be consistent
across the Community
(g) if the device is costum-made[sic],
the words ‘custom-made device’
(h) if the device is intended for
clinical investigations, the words
‘exclusively for clinical
investigations’
(i) any special storage and/or
handling conditions
(j) any special operating
instructions
(k) any warnings and/or
precautions that must be taken
(l) year of manufacture for active
devices other than those covered by
(e). This indication may be included
in the batch or serial number
(m) where applicable, method of
sterilization
(n) in the case of a device within the
meaning of Article 1(4a), an
indication that the device contains
a human blood derivative
— MDD Annex I(13.3) (page 31)16
In Great Britain, these label requirements
remain the same but have been modified
by UK MDR 2020 regulation 12(f)23 as
follows:
•Point (a): the first two references to “the
Community” are substituted with
“Great Britain”, the third reference to
“the Community” is substituted with
“the United Kingdom” and “the
authorised representative” is substituted
with “the UK responsible person”
•Point (f): the second sentence is omitted
•Point (n): “in the case of a device within
the meaning of Article 1(4a),” is omitted
For Northern Ireland and the EU,
labelling requirements are set out in EU
MDR Annex I(23.2),20 which is
comparable with MDD Annex I(13.3).16
Under the EU MDR, with regards to
CMDs in a dental setting, there are
three additional pieces of information
that need to be included on the label:
•Point (a): the name or trade name of
the device (e.g. “Hawley retainer”).
•Point (b): the intended purpose of the
device (e.g. “retain teeth in position
following orthodontic treatment”).
•Point (q): An indication that the
device is a medical device (the words
“medical device” needs to be
included on the label).
Table 2 sets out the label requirements
under the MDD/UK MDR 2002 (as
amended by UK MDR 2020) alongside
those under the EU MDR and indicates
the obligations that relate to CMDs in a
dental setting.
4. Which devices need
to be provided with
instructions for use?
In the MDD/UK MDR 2002, medical
devices are categorised into four
classes (I, IIa, IIb and III) according to
the potential risk they pose (Class I
devices are considered to be low risk
and Class III devices are deemed to
present the highest risk) with 18
classification rules.16 In the EU MDR,
the number of classification rules has
increased to 22 (EU MDR Annex
VIII20). Medical devices in a dental
context fall under rules 5 and 8 (see
Table 3).
Under the MDD, it is not necessary to
provide instructions for use with Class I
or IIa devices if they can be used safely
without them:
“Instructions for use must be included in
the packaging for every device. By way
of exception, no such instructions for use
are needed for devices in Class I or IIa if
they can be used safely without any such
instructions.”
— MDD Annex I(13.1) (page 30)16
This remains the same under the EU
MDR:
“Instructions for use shall be provided
together with devices. By way of
exception, instructions for use shall not
be required for class I and class IIa
devices if such devices can be used
safely without any such instructions and
unless otherwise provided for elsewhere
in this Section.”
— EU MDR Annex I (23.1d) (page
103)20
As Table 4 demonstrates, with the exception
of dental implants, CMDs in a dental setting
fall under Class I or IIa. Therefore, Class I or
IIa devices do not need to be provided with
instructions for use if they can be safely
used without them.16,20
5. Does the documentation
that accompanies a
custom-made device
need to include the GDC
registration numbers of those
who prescribe and construct
the devices?
Yes. The General Dental Council
Guidance on advertising provides the
information that should be included on
documents that contain the names of
registrants (Table 5). One such item of
information is the GDC registration
number.27
6. Who is responsible
for providing the
documentation?
The responsibility of providing the
documentation rests with the
manufacturer. Medical device legislation
defines the manufacturer as:
“(a) the person with responsibility for
the design, manufacture, packaging
and labelling of a device before it is
placed on the market under his own
name, regardless of whether these
operations are carried out by that
person himself or on his behalf by a
third party; or
(b) any other person who assembles,
packages, processes, fully refurbishes
or labels one or more ready-made
products or assigns to them their
intended purpose as a device with a
view to their being placed on the
market under his own name, apart from
a person who assembles or adapts
devices already on the market to their
intended purpose for an individual
patient”
— UK MDR 2002 regulation 2
(page 5)17
“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”
— EU MDR Article 2 (page 17)20
In a dental context, the prescriber (most
commonly a dentist but may be a clinical
Primary Dental Journal
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Medical device Regulations and custoM-Made device
docuMentation: ten FaQs and theiR answeRs
TABLE 2
CUSTOM-MADE DEVICE LABEL REQUIREMENTS UNDER UK AND EU LEGISLATION
Great Britain Northern Ireland / European Union Applicable to
CMDs in a
dental
context
MDD Annex I(13.3) (page 31)16 as modified by UK
MDR 202023 EU MDR Annex I Section 23.2 (page 104)20
— (a) the name or trade name of the device; Yes
(a) the name or trade name and address of the
manufacturer. For devices imported into Great
Britain, in view of their distribution in Great
Britain, the label, or the outer packaging, or
instructions for use, shall contain in addition
the name and address of the UK responsible
person where the manufacturer does not have
a registered place of business in the United
Kingdom;
(c) the name, registered trade name or registered trade
mark of the manufacturer and the address of its
registered place of business;
(d) if the manufacturer has its registered place of business
outside the Union, the name of the authorised
representative and address of the registered place of
business of the authorised representative;
(b) the details strictly necessary to identify the
device and the contents of the packaging
especially for the users;
(b) the details strictly necessary for a user to identify the
device, the contents of the packaging and, where it is
not obvious for the user, the intended purpose of the
device;
(c) where appropriate, the word ‘STERILE’; (l) if the device is supplied sterile, an indication of its
sterile state and the sterilisation method;
No
(m) where applicable, method of sterilization;
(d) where appropriate, the batch code, preceded
by the word ‘LOT’, or the serial number;
(g) the lot number or the serial number of the device
preceded by the words LOT NUMBER or SERIAL
NUMBER or an equivalent symbol, as appropriate;
(e) where appropriate, an indication of the date
by which the device should be used, in safety,
expressed as the year and month;
(j) where there is no indication of the date until when it
may be used safely, the date of manufacture. This date
of manufacture may be included as part of the lot
number or serial number, provided the date is clearly
identifiable;
Yes
(l) year of manufacture for active devices other
than those covered by (e). This indication may
be included in the batch or serial number;
(f) where appropriate, an indication that the
device is for single use.
(n) if the device is intended for single use, an indication of
that fact. A manufacturer’s indication of single use shall
be consistent across the Union;
No
(g) if the device is costum-made[sic], the words
‘custom-made device’;
(p) if the device is custom-made, the words ‘custom-made
device’;
Yes
(h) if the device is intended for clinical
investigations, the words ‘exclusively for
clinical investigations’;
(q) an indication that the device is a medical device. If the
device is intended for clinical investigation only, the
words ‘exclusively for clinical investigation’;
(i) any special storage and/or handling
conditions;
(k) an indication of any special storage and/or handling
condition that applies;
(j) any special operating instructions; (m) warnings or precautions to be taken that need to be
brought to the immediate attention of the user of the
device, and to any other person. This information may
be kept to a minimum in which case more detailed
information shall appear in the instructions for use,
taking into account the intended users;
(k) any warnings and/or precautions to take;
(Continued)
VOL. 11 NO. 2 SUMMER 2022 27
Great Britain Northern Ireland / European Union Applicable to
CMDs in a
dental
context
MDD Annex I(13.3) (page 31)16 as modified by UK
MDR 202023 EU MDR Annex I Section 23.2 (page 104)20
(n) an indication that the device contains a
human blood derivative.
(e) where applicable, an indication that the device
contains or incorporates:
No
— a medicinal substance, including a human blood or
plasma derivative, or
— tissues or cells, or their derivatives, of human
origin, or
— tissues or cells of animal origin, or their derivatives,
as referred to in Regulation (EU) No 722/2012;
— (f) where applicable, information labelled in accordance
with Section 10.4.5.;
(h) the UDI carrier referred to in Article 27(4) and Part C
of Annex VII;
(i) an unambiguous indication of t[sic] the time limit for
using or implanting the device safely, expressed at
least in terms of year and month, where this is relevant;
(o) if the device is a single-use device that has been
reprocessed, an indication of that fact, the number of
reprocessing cycles already performed, and any
limitation as regards the number of reprocessing
cycles;
(r) in the case of devices that are composed of
substances or of combinations of substances that are
intended to be introduced into the human body via a
body orifice or applied to the skin and that are
absorbed by or locally dispersed in the human body,
the overall qualitative composition of the device and
quantitative information on the main constituent or
constituents responsible for achieving the principal
intended action;
(s) for active implantable devices, the serial number, and
for other implantable devices, the serial number or the
lot number.
TABLE 2 (CONTINUED)
Primary Dental Journal
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Medical device Regulations and custoM-Made device
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TABLE 3
CLASSIFICATION RULES PERTAINING TO CUSTOM-MADE DEVICES
IN A DENTAL CONTEXT (INVASIVE DEVICES; RULES 5 AND 8)
UK MDR 2002 regulation 7 (page 8)17 / MDD Annex IX(2.1) (pages 54/58)16 / EU MDR Annex VIII Chapter III (pages 142/143)20
Rule 5 All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for
connection to an active device or which are intended for connection to a Class I active device are classified as:
• Class I if they are intended for transient use;
• Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear
canal up to the ear drum or in the nasal cavity, in which case they are classified as Class I; and
• Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear
canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which
case they are classified as Class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a Class
IIa, Class IIb or Class III active device, are classified as Class IIa.
Rule 8 All implantable devices and long-term surgically invasive devices are classified as Class IIb unless they:
Are intended to be placed in the teeth, in which case they are classified as Class IIa;
Are intended to undergo chemical change in the body in which case they are classified as Class III, except if the devices are
placed in the teeth
TABLE 4
CLASSIFICATION RULES PERTAINING TO CUSTOM-MADE DEVICES IN A DENTAL CONTEXT
UK MDR 2002 regulation 7 (page 8)17 / MDD Annex IX (pages 52-56)16 / EU MDR Annex VIII (pages 140-145)20
Class I IIa IIb III
Rule 5 –
Duration Transient Short term
Duration
definition
Normally intended
for continuous use
for less than 60
minutes
Normally intended for
continuous use for
between 60 minutes
and 30 days
CMDs Special trays
Intermediate
orthognathic wafers
Arch bars
Final orthognathic
wafers
Bruxism splints
Dentures
Orthodontic
appliances
Crowns
Bridges
Inlays
Onlays
Dental implants
Normally intended for continuous use for more than
30 days
Placed in the teeth
Long term
8
Used in the oral cavity as far as the pharynx
Implantable devices and
long-term surgically invasive
devices
Invasive devices with respect to body orifices, other than
surgically invasive devices, which are not intended for
connection to an active medical device or which are
intended for connection to a Class I active device
VOL. 11 NO. 2 SUMMER 2022 29
TABLE 5
GDC GUIDANCE REGARDING DOCUMENTATION THAT
CONTAINS THE NAME OF A REGISTRANT27
“Whenever you, your practice, or any place where you work as a registrant, produce
any information containing your name, you are responsible for checking that it is
correct. You must:
i) ensure information is current and accurate;
ii) make sure that your GDC registration number is included;
iii) use clear language that patients are likely to understand;
iv) back up claims with facts;
v) avoid ambiguous statements; and
vi) avoid statements or claims intended or likely to create an unjustified expectation
about the results you can achieve.”
dental technician in the case of complete
dentures) and the dental professional
who constructs the CMD (usually a
dental technician but may be another
dental professional) share the definition
of manufacturer. The prescriber “has a
device designed, manufactured or fully
refurbished” and the dental professional
who constructs the device “manufactures
or fully refurbishes a device”.20 In
practice, the documentation will typically
be provided by the dental technician
who constructed the device but the
prescriber also bears this responsibility
and must ensure that the statement is
made available to the patient.
7. Can memberships or
fellowships of professional
associations or societies
or honorary degrees in an
abbreviated form be
included on the documentation
that accompanies a
custom-made device?
No. GDC Standard 1.3.3 states that
“You must make sure that any
advertising, promotional material or
other information that you produce is
accurate and not misleading, and
complies with the GDC’s guidance on
ethical advertising.” 26 The General
Dental Council Guidance on
advertising27 states that:
“Patients may think that letters after your
name indicate that you have gained
further qualifications. You must not list
memberships or fellowships of
professional associations, or societies or
honorary degrees in an abbreviated
form because it may mislead patients.”
— General Dental Council Guidance on
advertising, 30 September 201327
8. Do special trays
need to be provided
with a statement?
The MDD and the UK MDR 2002 specify
that:
“Class IIa, IIb and III devices shall be
accompanied by the statement referred
to in Annex VIII, which shall be available
to the particular patient identified by
name, an acronym or a numerical
code.”
— MDD Article 4(2) (page 10)16
“A custom-made device—
(a) in respect of which the conditions
specified in Annex VIII are satisfied; and
(b) in the case of a Class IIa, Class IIb
and Class III device, which is
accompanied by the statement required
by Section 1 of Annex VIII, shall be taken
to comply with the relevant essential
requirements unless there are reasonable
grounds for suspecting that the device
does not comply with those
requirements.”
— UK MDR 2002 regulation 9(5) (page 9)17
Since special trays are Class I medical
devices (Table 4) they do not need to be
accompanied by a statement. The
comparative sentence in the EU MDR
does not make this class stipulation,
meaning that special trays manufactured
in Northern Ireland and in the EU should
now be supplied with a statement:
“Custom-made devices shall be
accompanied by the statement referred
to in Section 1 of Annex XIII, which shall
be made available to the particular
patient or user identified by name, an
acronym or a numerical code.”
— EU MDR Article 21(2) (page 33)20
The same is true for all Class I CMDs in
a dental setting (those used in the oral
cavity as far as the pharynx and
normally intended for continuous use
for less than 60 minutes), such as
intermediate orthognathic wafers.
9. Should the documentation
that accompanies a
custom-made device
feature the CE mark?
The CE mark consists of the initials ‘CE’
and is used to indicate that a device is in
conformity with the applicable requirements
set out within the legislation (Figure 1).
Under the MDD/UK MDR 2002, the
documentation that accompanies a CMD
was not required to bear the CE mark:
“Devices, other than devices which are
custom-made or intended for clinical
investigations, considered to meet the
essential requirements referred to in Article
3 must bear the CE marking of conformity
when they are placed on the market.”
— MDD Article 17(1) (page 20)16
“Regulation 10 [CE marking of general
medical devices] shall not apply to
a custom-made device or a device
intended for clinical investigation.”
— UK MDR 2002 regulation 12(2)17
This remains the case under the new
legislation:
“Devices, other than custom-made or
investigational devices, considered to be
in conformity with the requirements of this
Regulation shall bear the CE marking of
conformity.”
— EU MDR Article 20(1) (page 32)20
In the UK, the CE mark is being replaced
Primary Dental Journal
30
Medical device Regulations and custoM-Made device
docuMentation: ten FaQs and theiR answeRs
by the UKCA mark, which consists of the
initials ‘UKCA’ (Figure 2).28 The UKCA
mark does not apply to CMDs either.
10. Do custom-made
devices need to be
provided with an EU
declaration of conformity?
The EU declaration of conformity is a
document provided by medical device
manufacturers or their authorised
representatives to declare that their
devices meet the EU requirements. Under
the MDD (and hence UK MDR 2002),
the EU declaration of conformity is not
applicable to CMDs:
“In the case of devices falling within
Class IIa, other than devices which are
custom-made or intended for clinical
investigations, the manufacturer shall,
in order to affix the CE marking,
follow the procedure relating to the
EC declaration of conformity set out in
Annex VII. . .”
— MDD Article 11(2) (page 13)16
“In the case of devices falling within
Class I, other than devices which are
custom-made or intended for clinical
investigations, the manufacturer shall,
in order to affix the CE marking, follow
the procedure referred to in Annex VII
and draw up the EC declaration of
conformity required before placing the
device on the market.”
— MDD Article 11(5) (page 14)16
This remains the case under the EU
MDR:
“Where compliance with the applicable
requirements has been demonstrated
following the applicable conformity
assessment procedure, manufacturers
of devices, other than custom-made
or investigational devices, shall draw
up an EU declaration of conformity
in accordance with Article 19, and
affix the CE marking of conformity in
accordance with Article 20.”
— EU MDR Article 10(6) (page 23)20
For CMDs the statement is the
declaration of conformity.
Conclusion
CMDs must be manufactured in
accordance with current medical device
legislation. An important part of this is
the documentation that must be
supplied with such devices: a
statement, a label and, depending on
the risk class, instructions for use. This
paper has provided answers to some
key questions regarding the information
that needs to be included on this
documentation, but it is not intended to
be a substitute for reading the
legislation directly.
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