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Drug-device products.

F Tarabah¹, G Taxacher

¹TUV Product Service GmbH Paris, France.

Medical Device Technology

|October 28, 1999

Summary

This article explains the regulation of drug-device products, which often require adherence to both the Medical Device Directive and Medicinal Product Directive, detailing necessary conformity assessments.

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Area of Science:

Regulatory Affairs
Medical Device Regulation
Pharmaceutical Regulation

Background:

Drug-device products present unique regulatory challenges, often falling under multiple European directives.
Existing regulations include the Medical Device Directive and the Medicinal Product Directive.
Some products necessitate compliance with requirements from both directives.

Purpose of the Study:

To provide a comprehensive overview of the regulatory landscape for drug-device products.
To clarify the application of the Medical Device Directive and Medicinal Product Directive to these combination products.
To outline the required conformity assessment procedures for drug-device products.

Main Methods:

Review of relevant European Union directives (Medical Device Directive, Medicinal Product Directive).
Analysis of regulatory pathways for combination products.
Explanation of conformity assessment procedures.

Main Results:

Drug-device products are regulated under either the Medical Device Directive or the Medicinal Product Directive.
Specific product types require cross-referencing and adherence to requirements from both directives.
Conformity assessment procedures are detailed for these complex products.

Conclusions:

Understanding the dual regulatory requirements is crucial for drug-device product approval.
Clear guidelines on conformity assessment streamline the regulatory process.
This overview aids manufacturers in navigating the complex regulatory framework for drug-device products.

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