EU MDR Standards Update

The European Commission continues to advance the implementation of harmonised standards under the EU medical devices framework, supporting compliance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). These standards play a critical role in enabling manufacturers to demonstrate conformity with essential safety and performance requirements.

Role of Harmonised Standards

Harmonised standards are European technical specifications developed by recognized standardisation bodies such as CEN and CENELEC under mandates issued by the European Commission.

Once referenced in the Official Journal of the European Union (OJEU), these standards provide manufacturers with a presumption of conformity with the applicable legal requirements of MDR and IVDR.

While the application of harmonised standards remains voluntary, their use significantly simplifies compliance by offering a structured and widely accepted pathway to meet regulatory obligations.

Legal Framework and Standardisation Mandate

Harmonised standards are developed under the framework of standardisation request M/575, which defines the scope and priorities for standards supporting MDR and IVDR implementation.

The legal basis includes:

• Regulation (EU) 2017/745 (MDR)
• Regulation (EU) 2017/746 (IVDR)

These regulations require manufacturers to demonstrate compliance with General Safety and Performance Requirements (GSPRs), for which harmonised standards serve as a key technical tool.

Latest Developments (2025–2026)

The European Commission has continued publishing updated references to harmonised standards through Implementing Decisions, reflecting ongoing alignment with MDR and IVDR.

Key developments include:

• Regular updates to the list of harmonised standards published in the OJEU
• Inclusion of revised and newly adopted standards covering safety, performance, and risk management
• Continued transition from legacy directives (MDD/IVDD) to MDR/IVDR-aligned standards

These updates ensure that standards remain consistent with evolving regulatory expectations and technological advancements in the medical device sector.

Compliance and Operational Implications

The use of harmonised standards provides several regulatory advantages:

• Facilitates CE marking by demonstrating conformity with GSPRs
• Reduces the burden of proof during conformity assessment
• Supports smoother interactions with notified bodies

However, manufacturers choosing not to apply harmonised standards must:

• Demonstrate compliance through alternative technical solutions
• Provide detailed justification and supporting evidence
• Ensure equivalent levels of safety and performance

Additionally, companies must continuously monitor updates to harmonised standards to ensure ongoing compliance, particularly when standards are revised, replaced, or withdrawn.

Affected Stakeholders

The framework impacts:

Medical device manufacturers

• In vitro diagnostic (IVD) manufacturers
• Notified bodies responsible for conformity assessment
• Importers, distributors, and authorised representatives

All stakeholders involved in the EU medical device supply chain must ensure alignment with the latest harmonised standards where applicable.

Ongoing Compliance Considerations

• There is no single compliance deadline; however:

• Compliance is continuous and dynamic, linked to updates in OJEU publications
• Manufacturers must track newly listed or revised standards
• Transition periods may apply when standards are updated or replaced

Failure to align with the latest standards may result in increased scrutiny during conformity assessments or delays in CE marking.

Harmonised standards remain a cornerstone of the EU medical device regulatory framework under MDR and IVDR. With continuous updates through European Commission Implementing Decisions, manufacturers must proactively monitor and adopt relevant standards to ensure compliance, maintain CE marking, and secure uninterrupted access to the EU market.

Source: Harmonised Standards for Medical Devices