EMERGO SUMMARY OF KEY POINTS:

• The European MDR and IVDR require medical device manufacturers to publish user information on their websites.
• Publishing user information on a manufacturer’s website makes Regulation (EU) 207/2012 on e-labelling applicable.
• The e-labelling Regulation is only applicable to medical devices, not for IVDs.
• This simple requirement may have consequences for firms’ quality management systems as well as their agreements with importers and distributors.

Section 23.1 of Annex I of the Medical Devices Regulation (EU) 745/2017 (MDR) and section 20.1 of Annex I of the In-Vitro Diagnostic Medical Devices Regulation (EU) 746/2017 (IVDR) pertain to requirements that looks quite simple: If the manufacturer has a website, it must publish the user information (label, instructions for use (IFU), technical manuals etc.) online. However clear and straightforward this may look, there are some unexpected consequences.

Challenge: Labels and languages

The first issue has to do with a typical European challenge: languages. This requirement covers all languages in which the label and/or IFU are distributed. Some manufacturers treat their user information as controlled documentation, so may find it relatively easy to get all these documents organized. But other firms may have left translation responsibilities to local distributors. Now they have to gather these documents and organize them. This could be quite challenging, with some possibly significant deviations from these companies’ corporate identities. Therefore more manufacturers will likely adopt the practice of treating user information as controlled documents.

Challenge: Compliance statements

There is another reason for covering medical device user information within the scope of a manufacturer’s quality management system. The manufacturer remains responsible for the content of the user information, as required in Annex I, and only the manufacturer can claim compliance. This includes all translations. According to article 16 in the MDR and IVDR, importers and distributors can add labels to devices without being considered manufacturers themselves. But only under the condition (see article 16.2) that this is done in accordance with the requirements in Annex I; again, only the manufacturer can state that compliance.

Challenge: e-Labeling regulations

Another consequence of publication of user information on the manufacturer’s website is that this makes Regulation (EU) 207/2012 on e-labelling applicable. Article 1 of that regulation, second paragraph states that this regulation is also applicable for user information published on the manufacturer’s website. In this regulation a particular paragraph is of interest: Article 7.2 (g) requires to keep previous versions available on that website. However, there is a catch. The e-labelling directive is only applicable for medical devices and active implantable devices, not for IVDs. This implies that the user information on the website related to devices covered under the MDR will have to contain older versions, but for IVDs this is (currently) not required. For now Emergo assumes the “previous versions” are those that are issued under the MDR, and we may see guidance stating they can be removed 10 or 15 years after the last device with that information has been placed on the market (maybe with certain exceptions).

In summary: The manufacturer should publish all user information that accompanies the device on its website. This must be done in all languages in which that user information has been translated. For medical devices, older versions of user information must be kept available.

Related European MDR and IVDR resources from Emergo:

• European CE Mark consulting and strategy for medical devices
• European CE Mark consulting and strategy for IVD devices
• European MDR 2017/745 gap assessment and transition strategy support
• Whitepaper: Understanding Europe’s MDR
• Whitepaper: Understanding the European IVDR