Proposed MDR Article 50 Raises Concerns Over Notified Body Independence and Financial Sustainability

A newly published legal opinion has raised significant concerns regarding the European Commission’s proposed Article 50 MDR, part of the broader legislative proposal to amend the MDR and IVDR framework.

The expert opinion, prepared by Prof. Dr. Ulrich Haltern (LMU Munich), examines whether the proposed measures are compatible with EU law, particularly the freedom to conduct a business under Article 16 of the Charter of Fundamental Rights of the European Union (CFREU).

What Would Proposed Article 50 Introduce?

The proposal would introduce several new obligations for notified bodies, including:

• Mandatory fee reductions:

  • at least 50% reduction for micro enterprises;

  • at least 25% reduction for small enterprises;

  • at least 50% reduction for orphan device applications.

• Deferred payment obligations allowing micro and small enterprises to postpone payment until conformity assessment activities are completed.

• Potential Commission control over fee structures, through implementing acts defining the structure and level of notified body fees.

• Mandatory access obligations, including the possibility for competent authorities to instruct a notified body to accept a manufacturer’s conformity assessment request under certain public health circumstances.

Why Does This Matter for Manufacturers?

Although the proposal is designed to support SMEs, orphan devices, innovation, and device availability, the opinion argues that the measures could create unintended consequences across the conformity assessment ecosystem.

The analysis highlights concerns that notified bodies may be required to:

• charge significantly lower fees;

• wait longer for payment;

• absorb additional financial and default risk;

• and potentially accept projects they would otherwise decline.

According to the opinion, this cumulative effect could place substantial financial and operational pressure on notified bodies, potentially affecting capacity, timelines, and long-term sustainability of the certification system.

For manufacturers, particularly SMEs, the proposal may initially appear beneficial due to reduced certification costs. However, the opinion suggests that if notified bodies face increased economic pressure, this could indirectly impact:

• availability of notified body capacity;

• certification lead times;

• access to specialised expertise;

• and overall predictability of conformity assessment activities.

Concerns Around Regulatory Design

The opinion does not challenge the legitimacy of supporting SMEs or improving device availability. Instead, it questions the mechanism chosen by the Commission.

The report argues that the proposal effectively shifts part of the public-policy burden onto private notified bodies without introducing corresponding compensation mechanisms or safeguards.

It also raises concerns regarding the proposed Commission powers under Article 50(3), suggesting that essential decisions regarding private notified body fee structures may require stronger legislative definition rather than being left to implementing acts.

What Happens Next?

The proposal remains part of the ongoing EU legislative process and may still be amended during discussions between the European Parliament and the Council.

Manufacturers should closely monitor developments, particularly SMEs and companies relying on orphan-device pathways, as any final version of Article 50 could significantly influence:

• certification costs;

• notified body access;

• project planning;

• and regulatory strategy under MDR and IVDR.

As discussions continue, industry stakeholders are expected to closely debate how to balance SME support, patient access, innovation, and the long-term sustainability of the notified body system.

Read the full document below.