MDR Labels

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 Labels,

1.     23.1. General requirements regarding the information supplied by the manufacturer

2.     23.2. Information on the labels

3.     23.3 Sterile packaging

MDR brings lot of changes. As compared to MDD, MDR Label requirements are more detailed, some NEW requirements are incorporated.

·       Per Article 18 MDR all implantable devices (Except WET) shall have patient information document and implant card label.

The below table shows some of the major MDR Label New requirements.

Label General Requirements

23.1 Information supplied by manufacturer 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).

23.1.(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, and/or on the packaging of multiple devices. (MDD 13.1, Highlighted text added in MDR)

23.1.(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.

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, Highlighted text added in MDR)

Label Content Requirements

23.2(a) The name or trade name of the device.

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), Highlighted 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(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; (MDD 13.3(d), Highlighted text added in MDR)

23.2(h) the UDI carrier referred to in Article 27(4) and Part C of Annex VI;

23.2(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;

23.2(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. (MDD 13.3(k), Highlighted text added in MDR)

23.2(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.

23.2(q1) An indication that the device is a medical device.

23.2 (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;

23.2 (s) for active implantable devices the serial number and for other implantable devices the serial number or the batch number.

23.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)

(a) an indication permitting the sterile packaging to be recognized as such,

(e) a description of the device,

(h) the month and year of manufacture,

(j) an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.

Article 18 Implant card and information to be supplied to the patient with an implanted device

(aa) Information to be supplied to the patient with an implanted device in accordance to Article 18

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;

(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 Label requirements :https://meddev-info.blogspot.com/2021/05/ivdr-labels.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