PMDA Application for CE Marked Devices: Data Utilization and Considerations

When medical device manufacturers with existing CE marking in Europe consider expanding into the Japanese market, many will undoubtedly ask, "Can European data be used as is?" The answer is, "Some parts can be utilized, but it cannot be used without modification."

This article explains how to utilize European data and the considerations for PMDA applications involving CE-marked devices.

Similarities and Differences between European and Japanese Regulations

First, it is crucial to understand the similarities and differences between both regulatory frameworks:

Similarities

• Adoption of IMDRF (formerly GHTF) Guidance: Both regulations are based on IMDRF guidance, and the concept of STED is common.
• Utilization of ISO Standards: International standards such as ISO 13485, ISO 14971, and ISO 10993 are recognized in both regulations.
• Concept of Clinical Evaluation: The approach of utilizing a Clinical Evaluation Report (CER) without conducting clinical trials is common.

Differences

Usable European Data

Technical Documentation

EU MDR's Technical Documentation has a structure similar to PMDA's STED. The following data can be directly utilized or referenced:

• Design and Manufacturing Information: Product description, design history, manufacturing process.
• Risk Management Documentation: Risk analysis based on ISO 14971 (requires confirmation of consistency with JIS T 14971).
• Non-clinical Test Reports: Test results based on ISO standards (requires confirmation of differences with JIS standards).
• Biocompatibility Assessment: Assessment based on ISO 10993 (requires confirmation of consistency with PMDA guidance).

Clinical Data

Literature and clinical data used in the EU MDR clinical evaluation can also be utilized in PMDA's Clinical Evaluation Report (CER). However:

• Conversion to a format compliant with PMDA's clinical evaluation guidance is necessary.
• Additional research of Japanese literature may be required.
• Justification of relevance to the Japanese medical environment and usage conditions is necessary.

Points Requiring Attention

Utilization of International Standards (ISO) and Importance of GLP

Test data based on ISO standards used for European certification can, in principle, be utilized directly for PMDA applications. There is no longer a need to worry about conformity to "Japan's unique evaluation criteria" as in the past.

However, the following two points are strictly checked as requirements for data utilization:

• GLP Compliance for Non-clinical Tests: Non-clinical data used for approval/certification applications, such as biological safety tests (ISO 10993), must, in principle, be conducted at GLP-compliant facilities. Even if GLP is not mandatory for certain tests in Europe, GLP compliance is generally required for applications in Japan. Therefore, please confirm the selection status of the testing laboratory.

• Compliance with the Latest International Standards: PMDA refers to the latest international standards (ISO/IEC). If certification is maintained in Europe based on an older version of a standard, a gap assessment against the latest ISO standard (and corresponding JIS standard) may be required.

Creation of Essential Requirements Checklist

An "Essential Requirements Checklist" equivalent to EU MDR's Annex I must be created based on Japan's PMD Act essential requirements. The EU version cannot be used as is.

Creation of Japanese Instructions for Use

Simply translating the EU version of the Instructions for Use is not sufficient; revisions are necessary to align with Japanese regulatory requirements (e.g., required information, contraindications, warnings).

Adjustment of Indications for Use

The indications for use (intended purpose) in the EU version may not always align with the intended use in Japan. It is crucial to set indications for use that are consistent with Japanese medical practices and insurance coverage.

Efficient Application Strategy

Key points for streamlining PMDA applications for CE-marked devices:

1. Conduct a Gap Analysis: Identify gaps between EU technical documentation and PMDA requirements early.
2. Confirm JIS Standard Compliance: Identify applicable JIS standards and confirm differences with existing test data.
3. Prepare Bridging Justification for Clinical Data: Prepare justification to bridge European clinical data to the Japanese patient population and usage environment.
4. Utilize PMDA Pre-consultation: Confirm PMDA's views on the strategy for utilizing CE-marked data in advance.

Actual Timeline

Estimated timeline for PMDA application of CE-marked devices:

For products recently CE-marked, the application preparation period may be shortened due to the wealth of data accumulated during the European review process.

MK Consulting Support

MK Consulting provides specialized support for PMDA applications of CE-marked devices. We offer comprehensive services, from gap analysis of European data to JIS standard compliance, bridging justification for clinical data, and Japanese translation of application documents.

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