Essentials of European Medical Device Regulatory Affairs

Other Guidance

• Notified body

• National Competent Authorities (CA) obliged to render decisions for any individual product (if asked) - Note: European opinion may differ

• European Court of Justice (“the Court”) the authoritative interpretation of Community law.

The Organisationfor Professionals inRegulatory Affairs

Classification of medical devices Classification dispute

Dispute on classification in the MDR MDR Art.51

• Any dispute between the manufacturer and the notified body concerned, arising from the application of the classification criteria, shall be referred for a decision to the competent authority of the Member State where the manufacturer has his registered place of business • The Competent Authority of the manufacturer shall notify the MDCG and the Commission of its decision • The decision shall be made available upon request

The Organisationfor Professionals inRegulatory Affairs

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