EU digital by default medtech plans signal shift in submissions, product information and online sales

Digitalisation is a recurring theme in the European Commission's simplification agenda. The Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) already contemplated electronic systems such as the European database on medical devices (Eudamed), while core provisions addressed the online sales of medical devices and diagnostics. 

The proposed amendments introduced on 16 December could push the system further towards a "digital by default" model . The explanatory memorandum accompanying this proposal highlights that fragmentation of governance structures and limited digitalisation can contribute to administrative and adjustment costs for both authorities and medtech or diagnostic operators. Stakeholders emphasised that digital tools could alleviate burdens, enhance efficiency and reduce resource constraints.

Key changes would include mandatory electronic submission of information, the digital provision of key compliance documents, clarified unique device identifier (UDI) and Eudamed registration duties, and new rules addressing online sales and interoperable IT systems. If adopted, these measures aim to reduce administrative burden, improve transparency and support more dynamic information exchange along the device lifecycle. 

Regulatory documentation

Under the current MDR and IVDR, manufacturers should draw up an EU declaration of conformity (DoC) and keep it up to date, but the manner of provision to authorities and customers or distributors is not fully specified. Paper documents remain common.

The proposal amends the relevant provisions to explicitly allow digital provision. Communicating DoCs digitally is introduced under specified conditions as a simplification measure. Manufacturers will be able to make DoCs available electronically, including via websites, provided that authenticity, integrity and accessibility are assured.

New article 52b of the MDR and article 48b of the IVDR (both titled as digitalisation of technical documentation, conformity assessment and reports) open the door for manufacturers to prepare technical documentation and reports in digital format – including structured, machine‑readable formats. This is permitted provided the documentation can be converted into a human-readable form and that version control is in place to allow retrospective conformity checks. Where such documentation is submitted to a notified body, the manufacturer and notified body should agree on the digital format to be used.

To support this shift, the Commission may adopt common specifications setting out minimum requirements or functional specifications for digital formats. The aim is to ensure that documentation remains reliable, interoperable across systems and consistent with emerging standards.

Digital label and instructions for use

The MDR and IVDR already permit electronic instructions for use (IFUs) in certain circumstances, a matter addressed in a recent draft amendment updating regulation (EU) 2021/2226. The proposal signals an intention to broaden this possibility, with the list of amendments referring to the digital provision of certain label information and IFUs, subject to implementing rules.

While the precise scope will be defined by future implementing acts, the direction of travel is to allow more product information to be provided digitally, particularly for professional‑use devices and in environments where internet access and electronic documentation systems are reliable. Implementing acts may define, for example, categories of devices or use settings where digital IFUs are permitted or encouraged, and set conditions for access, updates and data protection.

This can reduce printing and packaging burdens and allow manufacturers to update safety information more dynamically. It will, however, require careful consideration of users' access needs, especially in settings where digital access cannot be guaranteed.

Mandatory electronic submissions

The most far‑reaching digitalisation change is the introduction of article 110a (submission of information or documents) in the MDR. The draft provision states that the submission of information or documents in accordance with the regulation shall take place electronically. The corresponding provision in the IVDR is article 103a, which bears the same title.

This mandatory electronic submission requirement aligns with the Commission's recent implementing decision establishing May 2026 as the date from which use of Eudamed becomes gradually obligatory for manufacturers and other economic operators.

When read with existing provisions on Eudamed and the specific electronic systems for vigilance, clinical investigations and performance studies, this suggests that applications, notifications, periodic safety updated reports, incident reports, clinical investigation documentation and other regulatory submissions should be made via electronic platforms: that is, either Eudamed itself or interoperable systems designated by the Commission.

Article 123 (entry into force and date of application) of the MDR is amended to clarify that, once the Eudamed provisions apply, Member States maintaining national databases should retrieve relevant information from Eudamed. This underlines Eudamed's central role as the authoritative source of device information at Union level.

UDI and Eudamed clarifications

The proposal amends the existing regulations to clarify UDI and registration obligations for different device categories and economic operators. These clarifications aim to ensure that devices benefiting from transitional provisions or special pathways – such as orphan devices  – are correctly represented in Eudamed, and that economic operators – including manufacturers, authorised representatives, importers – are properly identified with up‑to‑date, digital contact details.

Articles 110a of the MDR and 103a of the IVDR and the amendments to annex VI (UDI and registration requirements) to both regulations collectively confirm that economic operators should be ready to interact with Eudamed as the primary registry, including for UDI‑DI assignments, registration of device data and uploading of certificates.

Interoperable electronic systems 

Recognising that not all Member States or stakeholders may be able to rely solely on Eudamed for all regulatory interactions, the proposal allows for the possibility of establishing electronic systems outside Eudamed while maintaining interoperability requirements.

This approach is reflected in provisions such as article 106b (support by the EMA) of the MDR, which allows the European Medicines Agency (EMA) access to any electronic system for device registration, clinical investigations, vigilance, post-market surveillance, or market surveillance that is not included in Eudamed. Another example includes a new, proposed article 108a (international regulatory and administrative cooperation) of the MDR, which contemplates the use of electronic systems for exchange of information with third‑country regulators.

The Commission may recognise other systems, including EMA‑run platforms or national and regional IT tools, provided they are interoperable with Eudamed and comply with data protection and security standards.

Online sales and digital information 

The MDR and IVDR already contain provisions on distance sales. Those require that devices offered to persons in the EU via information society services comply with the regulations. The proposal does not radically change these articles but, in the context of broader digitalisation and cyber provisions, reinforces expectations around the provision of essential information in online contexts.

In particular, the proposal mandates that those offering medical devices or diagnostics online (for example, through web shops, app stores or online market places) or using them in the context of a commercial activity for the remote provision of a diagnostic or therapeutic service (for example, in telemedicine settings) should provide in their offer:

• Device identification. The name or trade name of the device, along with details strictly necessary for users to identify it, understand the packaging contents, and recognise its intended purpose (where not obvious).
• Manufacturer details. The name, registered trade name or trademark of the manufacturer, together with the address of its registered place of business.
• Authorised representative information. If the manufacturer is based outside the EU, the name and registered business address of the authorised representative should be provided.
• Safety warnings. Warnings or precautions that need to be brought immediately to the attention of the device user and any other relevant person (bearing in mind this information may be kept to a minimum, with more detailed information appearing in the IFU, tailored to the intended users)
• Access to the IFU.

Member States' market surveillance authorities are empowered to take action under the regulations where devices sold online are non‑compliant. In addition, the Commission is granted new powers under the proposals to engage in international cooperation, whereas reliance mechanisms extend to coordinated actions with third‑country regulators to address safety issues related to online sales.

Osborne Clarke comment

The proposed digitalisation measures, would represent a notable evolution of the MDR and IVDR framework, if adopted in their current form following the EU legislative process. Moving towards streamlined mandatory electronic submissions, structured electronic technical documentation and digital provision of compliance documents could offer benefits in terms of reduced administrative friction and enhanced transparency.

For manufacturers and other economic operators, these proposals would also have other practical implications across several areas.

Regulatory IT infrastructure would need to be capable of producing and managing version-controlled documentation in formats acceptable to notified bodies and authorities. Quality management systems may need to embed digital document control and electronic record-keeping practices, while customer-facing systems, including websites and e-commerce platforms, would likely require review to ensure device listings display the necessary regulatory information and that links to digital IFUs (and DoCs, where needed) are correctly implemented. Maintaining accurate, up-to-date data in Eudamed or linked systems could become increasingly important as authorities may rely more heavily on these systems for market surveillance purposes.

For online and digitally enabled medtech and diagnostic businesses, the potential convergence of UDI, digital labelling, cyber incident reporting and Eudamed registration suggests that regulatory compliance considerations may extend beyond technical and quality documentation into digital product design and commercial operations. As the legislative proposal progresses through the European Parliament and Council, stakeholders may wish to monitor developments and consider how these requirements might be integrated into their digital roadmaps and governance structures.