IVDR Annex I GSPR Section 20 of IVDR have requirements regarding the information supplied by the manufacturer.
The following section provides requirements which are applicable for Labels,
1. 20.1. General requirements regarding the information supplied by the manufacturer
2. 20.2. Information on the label
3. 20.3 Sterile packaging
IVDR brings lot of changes. As compared to IVDD, IVDR Label requirements
are more detailed, some NEW requirements are incorporated.
The below table shows some of the major IVDR Label New requirements.
|
Label General
Requirements |
|
20.1 Information supplied
by manufacturer shall be provided through manufacturer website. |
|
20.1. 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). (IVDD B.8.1 P1,
Highlighted text added in IVDR) |
|
20.1.(b) The information
required on the label shall be provided on the device itself. If this is not
practicable or appropriate, some or all of the information may
appear on the packaging for each unit. If individual full labelling of
each unit is not practicable, the information shall be set out on the
packaging of multiple devices. (IVDD B.8.1 P3,
Highlighted text added in IVDR) |
|
20.1.(c) Labels shall be
provided in a human-readable format and may be supplemented by
machine-readable information, such as radio-frequency identification (‘RFID’)
or bar codes. |
|
20.1.(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. (IVDD B.8.2, Highlighted
text added in IVDR) |
|
20.1.(j) The provisions
of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless
all relevant information, as appropriate, is already made available in the
instructions for use. |
|
Label Content
Requirements |
|
20.2(g) The UDI carrier
as referred to in Article 24 and Part C of Annex VI; |
|
20.2(i) 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; |
|
20.2(j) Where relevant,
an indication of the net quantity of contents, expressed in terms of weight
or volume, numerical count, or any combination of thereof, or other terms
which accurately reflect the contents of the package |
|
20.2(n) If the
instructions for use are not provided in paper form in accordance with point
(f) of Section 20.1, a reference to their accessibility (or availability),
and where applicable the website address where they can be consulted; |
|
20.2(p) 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; |
|
20.2(q) If the device is
intended for self-testing or near-patient testing, an indication of
that fact (IVDD B.8.4(k),
Highlighted text added in IVDR) |
|
23.2(r) Where rapid assays are not intended for
self-testing or near-patient testing, the explicit exclusion hereof; |
|
20.2(s) Where device kits
include individual reagents and articles that are made available as separate devices,
each of those devices shall comply with the labelling requirements contained
in this Section and with the requirements of this Regulation; |
|
20.2(u). The label for
devices for self-testing shall bear the following particulars: |
|
20.2(u)(i).The type of
specimen(s) required to perform the test (e.g. blood, urine or saliva) |
|
20.2(u)(ii).The need for
additional materials for the test to function properly |
|
20.2(u)(iii). Contact
details for further advice and assistance |
|
20.2(u). The name of
devices for self-testing shall not reflect an intended purpose other than
that specified by the manufacturer |
|
20.3. Information on the
packaging which maintains the sterile condition of a device (‘sterile
packaging’) |
|
20.3 The following
particulars shall appear on the sterile packaging: |
|
(a) an indication permitting the sterile packaging to be recognized as
such, |
|
(b) A declaration that the device is in a sterile condition |
|
(c) The method of sterilisation, |
|
(d) The name and address of
the manufacturer, |
|
(e) a description of the
device, |
|
(h) the month and year of manufacture, |
|
(h) an instruction to check the instructions for use for what to do if
the sterile packaging is damaged or unintentionally opened before use. |
References:
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
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