European Commission’s proposal for revising EU MDR and IVDR: Key Points

The European Commission has published a far-reaching proposal to revise the MDR 2017/745 on medical devices and IVDR 2017/746 on in-vitro diagnostic medical devices, with the stated aim of simplifying the system, reducing burden and improving availability of devices in Europe, while keeping a high level of patient safety.

What Does the New EU MDR and IVDR Revision Proposal Mean for Manufacturers in Europe?

For PRRCs, QARA teams and medical device manufacturers, this MDR revision could reshape day-to-day regulatory work: from how you generate clinical evidence, interact with notified bodies and use expert panels, to how you manage in-house devices, niche indications and long-term certificate maintenance.

The proposal also pushes digitalisation (Eudamed, UDI, electronic documentation) and introduces tools such as regulatory sandboxes, structured dialogue with notified bodies and priority pathways for breakthrough and orphan devices.

Although language obligations remain largely national, there are signals that translation requirements for professional-use devices could become slightly more flexible, which makes your translation and language strategy a key element of MDR/IVDR compliance planning in the coming years.

Below we unpack the main building blocks of the proposal, why they matter, and how feasible they look from a practical compliance perspective.

Why Is the EU Revising the MDR and IVDR Now?

The Commission’s evaluation concluded that, while MDR and IVDR improved safety and transparency, they also created a system that is often complex, slow and disproportionately costly, especially for SMEs.

Key problems identified:

• Bottlenecks and variability in notified body practices
• Heavy clinical and post-market evidence requirements
• Fragmented governance and limited EU-level technical advice
• Negative impact on innovation, niche devices and availability

The new proposal aims to:

• Keep the safety and public-health objectives of MDR/IVDR
• Simplify and “right-size” requirements where risk is low
• Make certification more predictable and cost-efficient
• Increase EU-level coordination (EMA, expert panels, MDCG)

From a feasibility standpoint, the goals are realistic, but success will depend heavily on speedy secondary legislation, EMA capacity and how consistently Member States implement the new tools.

What Is the Practical Feasibility of the MDR/IVDR Revision for PRRC and QARA Teams?

For PRRCs and QARA leaders, the MDR revision is not a “light-touch” fix but a structural optimisation of the existing framework.

In practice, you should prepare for:

• Re-mapping of device portfolios to new classification and WET criteria
• Updating clinical and post-market evidence strategies using the new flexibility
• Revising change control and vigilance SOPs (new timelines, categories of changes)
• Re-negotiating agreements and expectations with notified bodies (structured dialogue, remote audits)
• Leveraging digitalisation for documentation, UDI and Eudamed

Overall feasibility is high, but timelines will be tight, and interim guidance will be essential. Many of the “simplifications” still require careful technical justification and high-quality documentation.

How Can Stakeholders Use the Commission’s “Have Your Say” Process?

The Commission’s proposal for a targeted revision of the MDR and IVDR is tied to its “Have Your Say” initiative on Medical devices and in vitro diagnostics – targeted revision of EU rules (initiative 14808). The adopted act is currently open for feedback from 7 January 2026 to 24 March 2026 (on 27/01/2026) (midnight Brussels time), with the eight-week period being extended daily until the proposal is available in all EU languages.

Manufacturers, notified bodies, healthcare professionals, patients and authorities can submit comments via the portal (registration or social-media login required). All feedback will be published and summarised by the Commission and forwarded to the European Parliament and Council, feeding directly into the legislative debate. For PRRCs and QARA teams, this is a concrete opportunity to highlight feasibility issues and propose improvements to the MDR/IVDR framework.

What Does the MDR Revision Mean for Translation Requirements and Language Strategy?

How Might Language Requirements Evolve Under the Proposal?

The proposal reiterates that each Member State remains responsible for deciding in which language information is supplied to users in its territory. However, it also explicitly invites Member States to consider accepting other EU languages commonly understood in the medical field, especially for professional-use devices, to reduce translation costs.

What this doesn’t mean

• It does not abolish national language rules.
• It does not guarantee that English (or any other language) will be accepted everywhere.

What it could mean

• Some Member States may become more flexible for professional-only devices (e.g. specialist capital equipment in university hospitals).
• Manufacturers might design tiered language strategies:
  • Full-translation countries (e.g. IFU and label fully in national language)
  • Countries allowing English or another common language for professional users
  • Mixed models, where safety-critical elements are localised, and some background material remains in English

How Do Digitalisation and Online Sales Increase Translation Needs?

Even if limited language flexibility appears, the MDR revision likely maintains or increases the overall need for high-quality translation:

• More digital content (eIFUs, web portals, online product description) that must be aligned linguistically with labels and paper IFUs.
• Increased cross-border online sales, where clear, localised instructions are vital to avoid misuse.
• Greater reliance on EU-level tools (Eudamed, EMA advisory procedures), where internal documents (CERs, PSURs, SSCPs) may need to be shared and understood by multi-national teams and authorities.

For PRRCs, inaccurate translation remains a regulatory risk, potentially leading to:

• Misuse or off-label use due to mistranslated indications or contraindications
• Non-compliance with Member State language laws
• Delays with notified bodies questioning inconsistencies between technical documentation and IFUs

Why Should European Manufacturers Prepare Now and Choose the Right LSP?

Although the European Commission’s MDR/IVDR revision is still a proposal, the political momentum and the need to stabilise the EU medical device market make its entry into force highly likely.

At the same time, the proposal does not change the key MDR and IVDR certification deadlines, which are still approaching fast for manufacturers across Europe. Waiting to adapt language, labelling and documentation strategies until the last moment increases the risk of bottlenecks with notified bodies and national authorities.

For medical device manufacturers in the EU, early collaboration with a translation company specialized in the translation of medical devices is therefore a strategic advantage. A qualified LSP can help design a multilingual documentation strategy that:

• Aligns translations with current and evolving language rules in each EU Member State
• Ensures consistent regulatory terminology across CERs, SS(C)Ps, IFUs, labels and digital content
• Supports PRRC and QARA teams with harmonised, audit-ready documentation

With tight timelines and evolving requirements in the European market, anticipating now, rather than waiting until the last moment, can protect market access, reduce regulatory risk and strengthen long-term compliance under the revised MDR and IVDR framework.

Conclusion: Why Is This Proposal a Turning Point for EU Manufacturers?

The Commission’s proposal to revise the MDR and IVDR is more than a technical adjustment: it will shape how devices and IVDs are developed, certified and maintained in Europe for years to come. If implemented well, more proportional requirements, clearer routes for niche and breakthrough devices, leaner notified-body processes and stronger digitalisation could remove key bottlenecks while preserving high patient safety.

Its real impact, however, will depend on secondary legislation, national implementation (including language rules) and the speed at which stakeholders adapt. For manufacturers, PRRCs, QARA teams and others, the transition is now partly in their own hands: by preparing portfolios and documentation early, and by building robust multilingual strategies with a specialised MDR/IVDR translation company, they can reduce regulatory risk, protect market access and actively help steer the system towards a more predictable, innovation-friendly framework when performing regulatory medical translations.