The White Paper “Medical Devices Labelling: instructions for use” explains, from the regulatory point of view, what are the labelling requirements for Medical Devices according to the MDR (EU) 2017/745 Regulation.
It is mandatory and fundamental to apply the
requirements for the labelling of Medical Devices as the information on the product label helps the user to identify and use it correctly. It
contributes to high standards of quality
and safety of devices produced or marketed in Europe.
In the MDR (UE) 2017/745 Regulation there are several parts dealing with the subject; so, we advise you to read this in-depth to have a comprehensive overview of the legislative requirements laid down.
Medical Devices Labelling: which are the main requirements?
At European level, with the full application
of the MDR (EU) 2017/745 Regulation on
Medical Devices on 26 May 2021 and
the IVDR (EU) 2017/746 Regulation on
in vitro Diagnostic Medical Devices on 26
May 2022, the industrial sector of Medical Devices is preparing for a major
regulatory change.
While the Medical
Devices labelling is dealt with in different parts of the regulations, in
this White Paper you can find the most
important labelling requirements for Medical Devices in a single document.
The main
labelling requirements and other related aspects are explained according to
the MDR (EU) 2017/745 Regulation.
First of all, the requirements of the instructions for use
(IFU) in Annex I of the MDR (EU) 2017/745 Regulation are
further developed. They are fundamental because it is through this information
that the Manufacturer can provide the user with details of the composition and
operation of the product, also indicating the safety warnings.
Secondly, we focus on the linguistic requirements necessary to be able to distribute a
Medical Device in the Member States of the European Union, as provided for in art.
10 of the MDR (EU) 2017/745 and in annex II of the MDR. These are important aspects for the Medical
Device labelling process because according to where the product is marketed, it
is necessary the provision of the information in the official language
established by the Member State.
Given the importance of language for achieving
compliance with regulations and ensuring the use of devices in the European
market, the validation process of the
translation of contents is also fundamental, as provided for in art. 16 of
the MDR (EU) 2017/745.
Other labelling requirements: symbology and UDI system
The use of symbols on the labels of Medical Devices, in compliance with the MDR (EU) 2017/745 Regulation, is another aspect that has been decided to address in the White Paper. Although not yet official, the standardization proposals elaborated by MedTech Europe are being examined by the ISO. MedTech Europe is a European trade association representing medical technology industries, from diagnosis to treatment.
Moreover, in the White Paper ample space is given to the UDI system as it is also a requirement of Medical Devices labelling provided by the Regulation. The UDI system allows the Manufacturer to identify and label devices through a unique identifier that increases its traceability throughout the supply chain, in order to be able to act promptly in case of need.
How to meet the requirements of the MDR (EU) 2017/745 Regulation on Medical Devices labelling?
In the last part of the document you will find
some useful tips to prepare yourself
for the implementation of these essential requirements provided for in the
Regulation.
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