Correction of quality standards for notified bodies: what changes in 2026

Key data

Notified bodies operating under the Regulation (EU) 2017/745 (MDR) and the Regulation (EU) 2017/746 (IVDR) must immediately incorporate the corrected texts of Commission Implementing Regulation (EU) 2026/977. This correction, published on 10 June 2026 in the Official Journal of the EU, ensures the correct application of the European regulatory framework for medical products without adding new substantive burdens, but does require precision in internal procedures.

For regulatory and quality departments in the healthcare sector, ignoring a correction of this type is not an option: certification procedures must reflect the official text in force at all times.

What does this regulation establish?

Commission Implementing Regulation (EU) 2026/977, approved on 4 May 2026, establishes uniform quality management requirements and conformity assessment procedures that must be followed by notified bodies designated under the MDR and IVDR.

The correction published on 10 June 2026 rectifies errors or inaccuracies detected in the original text of that regulation. Its specific scope is as follows:

• It affects the quality management requirements that notified bodies must comply with in their conformity assessment activities.
• It affects the conformity assessment procedures that these bodies apply to certify medical products and in vitro diagnostic products.
• It ensures the correct application of the European regulatory framework, without introducing new substantive obligations beyond those already contained in the original regulation.
• It applies to all notified bodies designated under the Regulation (EU) 2017/745 (MDR) and the Regulation (EU) 2017/746 (IVDR).

In practical terms, the correction does not rewrite the regulatory framework: it refines it. But notified bodies are obliged to always work with the official text in force, which makes it essential to update any internal procedure that cites or reproduces the corrected regulation.

Economic and operational impact

The correction does not generate new direct costs arising from additional substantive obligations. However, it does have operational implications that may translate into indirect costs:

• Notified bodies: Must review and, where appropriate, update their internal quality management and conformity assessment procedures to reflect the corrected text. This involves review time by regulatory and quality teams.
• Manufacturers of medical devices: If the certification procedures of their notified body are modified as a result of the corrected texts, they may be affected in the timelines or conditions of their ongoing certification processes.
• Regulatory departments: Need to update internal documentation that references Regulation (EU) 2026/977 to ensure they are working with the corrected version.

The actual economic impact will depend on the scope of the specific corrections introduced and whether they affect procedures already underway. In any case, the cost of not updating procedures—and working with outdated text during an audit or inspection—far exceeds the effort of preventive review.

Who does it affect?

• Notified bodies designated under Regulation (EU) 2017/745 (MDR) for the certification of medical devices in the EU.
• Notified bodies designated under Regulation (EU) 2017/746 (IVDR) for the certification of in vitro diagnostic products in the EU.
• Manufacturers of medical devices working with notified bodies to obtain or maintain their CE certification under the MDR.
• Manufacturers of in vitro diagnostic products working with notified bodies to obtain or maintain their CE certification under the IVDR.
• Regulatory and quality departments of healthcare sector companies that manage relationships with notified bodies.
• Consultants and regulatory advisors specializing in the medical devices sector in the EU.

Practical example

A Spanish manufacturer of class III medical devices (the highest risk, such as active implants) has an open conformity assessment file with its notified body under the MDR. The notified body, upon receiving the correction of Regulation (EU) 2026/977, detects that one of its internal technical documentation review procedures must be adjusted to the corrected text.

As a result, the notified body updates its procedure and notifies the manufacturer that the review of the file will follow the updated procedure. The manufacturer does not need to modify its technical documentation, but must be aware of the change to understand the criteria by which it will be evaluated and to update its internal references to the regulation if it has any.

This scenario illustrates why manufacturers' regulatory departments must maintain active monitoring of regulatory corrections: not only to comply, but to anticipate how they may affect their ongoing certification processes.

What should companies do now?

1. Notified bodies: review the corrected text of Regulation (EU) 2026/977 published on 10 June 2026 in the Official Journal of the EU and identify which sections have been modified compared to the original text of 5 May 2026.
2. Update internal procedures for quality management and conformity assessment that reference or reproduce the articles or annexes affected by the correction.
3. Manufacturers with ongoing certifications: contact their notified body to confirm whether the correction affects the procedures applicable to their file and on what timelines.
4. Regulatory departments: update internal documentation (SOPs, regulatory references, compliance matrices) that cite Regulation (EU) 2026/977 to reflect the corrected text.
5. Record the review in the organization's quality management system, leaving traceability of the impact analysis performed, especially for future audits.

Official source

Consult complete regulation at official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202690455