MDR Annex I GSPR Section 23 of MDR have requirements regarding the
information supplied by the manufacturer.
The following section provides requirements which are applicable for
instruction for use,
1.
23.1. General requirements regarding the information
supplied by the manufacturer
2.
23.4. Information in the instructions for use
MDR brings lot of changes. As compared to MDD, MDR IFU requirements are
more detailed, some NEW requirements are incorporated.
· Per Article 18 MDR
all implantable devices (Except WET) shall have patient information document.
· Reusable devices
shall have Information to identify when the device should no longer be reused, e.g.
signs of material degradation or the maximum number of allowable reuses.
The below table shows some of major MDR IFU New requirements.
|
IFU General Requirements |
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23.1 IFUs shall be
provided through manufacturer website. |
|
23.1.(a) The medium,
format, content, legibility, and location of the label and instructions for
use shall be appropriate to the particular device, its intended purpose and
the technical knowledge, experience, education or training of the intended
user(s). In particular, instructions for use shall be written in terms
readily understood by the intended user and, where appropriate, supplemented
with drawings and diagrams. |
|
23.1.(e) Where multiple
devices are supplied to a single user and/or location, a single copy of the
instructions for use may be provided if so agreed by the purchaser who in any
case may request further copies to be provided free of charge. |
|
23.1.(f) Instructions for
use may be provided to the user in non-paper format (e.g. electronic) to the
extent, and only under the conditions, set out in Regulation (EU) No 207/2012
or in any subsequent implementing rules adopted pursuant to this Regulation. |
|
23.1.(h) Where
appropriate, the information supplied by the manufacturer shall take the form
of internationally recognised symbols. Any symbol or identification
colour used shall conform to the harmonised standards or CS. In areas
for which no harmonised standards or CS exist, the symbols and colours shall
be described in the documentation supplied with the device. (MDD 13.2,Highligted text
added in MDR) |
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IFU Content Requirements |
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23.2(a) The name or trade
name of the device. |
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23.2(c) The name, registered
trade name or registered trade mark of the manufacturer and the address
of its registered place of business. (MDD 13.3(a),Highligted
text added in MDR) |
|
23.2(e) Where applicable,
an indication that the device contains or incorporates tissues or cells, or
their derivatives, of human origin, or |
|
23.2(e) Where applicable,
an indication that the device contains or incorporates tissues or cells of
animal origin , or their derivatives, as referred to in Regulation (EU) No
722/2012. |
|
23.2(f) Where applicable,
information labelled in accordance with section 10.4.5 (presence of CMRs and
Endocrine disrupting substances. (MDD only have phthalate) |
|
23.2(r) In the case of
devices that are composed of substances or 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 constituent responsible
for achieving the principal intended action. |
|
23.4(b) the device’s
intended purpose with a clear specification of indications, contraindications,
the patient target group or groups and of the intended users, as appropriate. |
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23.4(c) where applicable,
a specification of the clinical benefits to be expected. |
|
23.4(d) where applicable,
links to the summary of safety and clinical performance referred to in
Article 32 |
|
23.4(f) where applicable,
information allowing the healthcare professional to verify if the device is
suitable and select the corresponding software and accessories. (MDD 13.6(c) Partially
covered,MDR more detailed) |
|
23.4(g) any residual
risks, contra-indications and any undesirable side-effects, including
information to be conveyed to the patient in this regard. (MDD 13.6 ,Highligted
text added in MDR) |
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23.4(j) any requirements
for special facilities, or special training, or particular qualifications of
the device user and/or other persons. |
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23.4(l) if the device is
supplied sterile, instructions in the event of the sterile packaging being
damaged or unintentionally opened before use. (MDD 13.6(g) ,Highligted
text added in MDR) |
|
23.4(n) If the device is
reusable, information on the appropriate processes to allow reuse, including
cleaning, disinfection, packaging and, where appropriate, the validated
method of re-sterilisation appropriate to the Member State(s) where the
device is placed on the market. Information shall be provided to identify
when the device should no longer be reused, e.g. signs of material
degradation or the maximum number of allowable reuses. (MDD 13.6(h) ,Highligted
text added in MDR) |
|
23.4(o) An indication, if
appropriate, that a device can be reused only if it is reconditioned under
the responsibility of the manufacturer to comply with the general safety and
performance requirements. |
|
23.4(p) If the device
bears an indication that it is for single use, information on known
characteristics and technical factors known to the manufacturer that could
pose a risk if the device were to be re-used. This information shall be
based on a specific section of the manufacturer's risk management
documentation, where such characteristics and technical factors shall be
addressed in detail. If in accordance with point (d) of Section 23.1 no
instructions for use are required, this information shall be made available
to the user upon request. (MDD 13.6(h) ,Highligted
text added in MDR) |
|
23.4(t) 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 and that are absorbed by or
locally dispersed in the human body, warnings and precautions, where
appropriate, related to |
|
23.4(u) in the case of
implantable devices the overall qualitative and quantitative information on
the materials and substances to which patients can be exposed. |
|
23.4(v) Warnings or
precautions to be taken in order to facilitate the safe disposal of the
device, its accessories and the consumables used with it, if any. This
information shall cover, where appropriate. (Partially covered in
MDD) |
|
23.4(w) For devices
intended for use by lay persons, the circumstances in which the user should
consult a healthcare professional. |
|
23.4(x) For devices
covered by this Regulation pursuant to Article 1 (2), information regarding
the absence of a clinical benefit and the risks related to the use of the
device.(Devices without an intended medical purposeas in Article 1(2)) |
|
23.4(z) A notice to the
user and/or patient that any serious incident that has occurred in relation
to the device should be reported to the manufacturer and the competent
authority of the Member State in which the user and/or patient is
established. |
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(ab) for devices that
incorporate electronic programmable systems, including software, or software
that are devices in themselves, minimum requirements concerning hardware, IT
networks characteristics and IT security measures, including protection
against unauthorised access, necessary to run the software as intended. |
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Article 18 Implant card and
information to be supplied to the patient with an implanted device |
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(aa) Information to be
supplied to the patient with an implanted device in accordance to Article 18 |
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1. The manufacturer of an
implantable device shall provide together with the device the following: |
|
(a) information allowing
the identification of the device, including the device name, serial number,
lot number, the UDI, the device model, as well as the name, address and the
website of the manufacturer; |
|
(b) any warnings,
precautions or measures to be taken by the patient or a healthcare
professional with regard to reciprocal interference with reasonably
foreseeable external influences, medical examinations or environmental
conditions; |
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(c) any information about
the expected lifetime of the device and any necessary follow-up; |
|
(d) any other information
to ensure safe use of the device by the patient, including the information in
point (u) of Section 23.4 of Annex I |
Click below link to know more about IVDR IFU requirements :https://meddev-info.blogspot.com/2021/04/ivdr-instruction-for-use-ifu.html
Source:
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
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