Hi all, the wording 'indication for use' is not used in the MDR (nor in the MDD for that matter) and are as far as I know, used in relation with US medical device Regulations. Apart form that, indications for use are focused on the use of a product in relation to a therapy or diagnosis, but do not necessarily reveal the nature of the product as being a medical device or a medicinal product. So in my opinion 'indications for use' are not suitable as such to indicate a device as a medical device.
Like Dan explained the indication shall be on the label. The label shall be provided on the device (Ann I(23.1(b)) unless not practicable or appropriate.
The flexibility provided by the MDR in requiring what to do rather than how to do, is a blessing in disguise; without guidance, common specifications or harmonized standards it is up to you how to do this. And up to the Competent Authorities or Notified Bodies to accept it.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
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Original Message:
Sent: 21-Jul-2020 05:00
From: Richard Vincins
Subject: MDR labelling rules Class 1 non-sterile and non-measuring.
Hello Anon,
The statements from the Annex I for indicating the device is a medical device could have been written better or at least provided more succinct information about what this means, i.e. is the indications for use statement enough? is a statement in the IFU 'This is a medical device,' enough? and the symbol that has been proposed cover this requirement? I am hoping there will be some further guidance detailing how this requirement could be met. For me, if the indications for use is clear the product is a medical device, I would argue that is sufficient. However, many people are leaning toward the fact there needs to be the "MD" symbol in a box on the actual device label to meet this requirement. First, the "MD" symbol is not in any standard and certainly not a harmonised standard, so if you are using this symbol it clearly needs to be explained and described in a symbol glossary within the IFU. What you should think about is stating in the General Safety and Performance Requirements (GSPR), Annex I, how you are meeting this requirement and clearly describing in your regulatory strategy for compliance how this is being met. This requirement was added in because there are companies selling products could be construed as medical devices or accessories as medical devices in there own right, so this requirement clearly supports a company as indicated clearly their product is a medical device. It is up to the organisation within the GSPR, Annex I of the EU MDR to show how they are meeting this requirement.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 20-Jul-2020 11:25
From: Dan O'Leary
Subject: MDR labelling rules Class 1 non-sterile and non-measuring.
No, the medical device symbol is not required at all. What is required, Ann. I(23.2)(q), is that the label contain "an indication that the device is a medical device".
If you use a symbol, then follow Ann. I(23.1)(h), "Any symbol or identification color used shall conform to the harmonized standards or CS. In areas for which no harmonized standards or CS exist, the symbols and colors shall be described in the documentation supplied with the device".
Since the MDR does not have any harmonized standards or CSs, then describe all symbols in the documentation.
The MDR tells you what must happen, but seldom includes all possible combinations of things. If the symbol were required on the device, there would be a requirement in the MDR. The MDR doesn't says that the symbol doesn't need to be on the device.
Presumably, you ask the question because somebody thinks the symbol needs to be on the device. Have that person cite the requirement. (The burden of proof rests on the affirmative.)
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 18-Jul-2020 03:10
From: Anonymous Member
Subject: MDR labelling rules Class 1 non-sterile and non-measuring.
This message was posted by a user wishing to remain anonymous
Under the new MDR labelling rules does the medical device symbol (M in a box) need to be on the device. We manufacture both finished Class I devices and medical device component which are intended to be assembled, eg lower limb prosthetic components. These are also Class 1. In the latter case, does the symbol need to be on the device or will the packaging be okay. If the answer is " it doesn't need to be on the device" could you give me chapter and verse.
Regards