Is e-labeling allowed in the EU, UK and Switzerland?
E-labeling for medical devices and IVDs is allowable in certain cases in the EU, UK and Switzerland.  The requirements are based on the application legislation and device type.  The applicable regulations and guidances are linked at the bottom of this FAQ. Medical Devices E-labeling is allowed for the following types of medical devices, if they are for professional use and use by other persons is not foreseeable: Implantable and active implantable devices, Fixed installed medical devices and their accessories, and Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use. For all three markets, e-labeling is also permitted for professional use software products.  Further, under the updated e-labeling regulation related to the EU MDR, e-labeling is permitted for home-use software products.  The UK and EU MDD/IVDD/IVDR regulations, do not explicitly allow e-labeling for home-use software products, but in certain cases this may be justified.  Manufacturers can discuss further with their Notified Body (if applicable) or Competent Authority to confirm if it is allowable and should justify in their risk assessment that this will not impact the safe an effective use of the product with the end user. IVDs E-labeling is allowed for professional-use IVDs that are not specifically intended for use at point of care.* E-labeling Requirements Manufacturers should ensure they follow all the criteria outlined in the applicable regulation or guidance if choosing to offer e-labeling for their devices.  This generally includes, but is not limited to: Conducting a risk assessment that covers the criteria included in the applicable regulation/guidance Essentially, the assessment should demonstrate that the end-user has access to and knowledge of the technology being used to provide the e-IFU, sufficient back-up to provide the IFU if the technology fails, and that the user is able to receive the IFU in paper format, if needed/requested. Ensuring the e-IFU meets all the local language requirements where the product is sold Developing a process where the user can request the paper IFU at no additional cost, within the time period established by the regulation or guidance For medical devices, this is noted as 7 days whereas for IVDs the regulation just states it must be provided in a timely manner. Clearly indicating when the IFUs have been revised and the ability to inform the user if the revision was necessary for safety reasons Making the e-IFU accessible to users through a website that meets the criteria in the regulation or guidance In cases of medical devices with expiration dates, making the IFU available for the timeframes stipulated in the regulation or guidance: EU MDR: For non-implantable devices - 10 years after the last device has been placed on the market and at least two years after the expiry date of the last produced medical device.  For implantable devices - 15 years after the last device has been placed on the market. EU MDD/UK MD: For non-implantable devices - at least two years after the expiry date of the last produced medical device.  For implantable devices - 15 years after the last device has been placed on the market. IVDs: The IVD guidance does not reference any specific timeline for keeping the IFU available for expired devices. However, the legislation imposes minimum document retention periods: IVDD – 5 years after the last product has been manufactured IVDR – 10 years after the last device has been placed onto the market A full list of the criteria that must be met can be found in the regulation or guidance applicable to the market/device (linked below).  Legislation and Guidances Europe MDD: COMMISSION REGULATION (EU) No 207/2012 MDR: COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226 IVDD: MEDDEV 2.14/3 rev.1 IVDR: REGULATION (EU) 2017/746  (Annex I, Chapter III, Section 20.1(f)) In absence of a Commission Implementing Regulation to the IVDR 2017/746, manufacturers should consider the existing MEDDEV and MDR Commission Implementing Regulation for guidance. United Kingdom Medical Devices: Guidance on the regulations for electronic instructions for use of medical devices IVDs: MEDDEV 2.14/3 rev.1 Switzerland Swissmedic has not released any information related e-labeling requirements.  However, as both the Swiss medical device (MedDO) and IVD (IvDO) regulations align with the EU MDR and IVDR respectively, and compliance with these regulations is currently required for commercializing devices in Switzerland, EU requirements for e-labeling can generally be followed in Switzerland as well.  If there is a question if these requirements apply to a specific product, manufacturers should confirm with Swissmedic directly. *Point of Care Testing: Testing that is performed near or at the site of a patient with the result leading to a possible change in the care of a patient.