Below you will find a general process for MDR Compliance.

There are amended and new classification rules. Some producers might find their products grouped in higher risk classes under the MDR. There will be an extended version of the Essential Requirements, now called the General Safety and Performance Principles or Requirements (SPR). Also, the provisions for clinical evaluation and Post-Market Surveillance (PMS) have been revised.

MDR Compliance Process

Level 1: Appoint your European Authorized Representative

Level 2: Identify all EU Directives/Regulations applicable to your product (such as MDR, WEEE, EMC etc.)

Level 3: Select and perform the Conformity Assessment Procedure applicable to your product 

Level 4: Check your device against the General Safety and Performance Requirements (annex I)

Level 5: Identify the applicable harmonized standards for your product

Level 6: Prepare a Technical File (annex II and III) and implement a Quality Management System 

Level 7: Select a Notified Body (for classes Is, Im, Ir, IIa/b and III) and sign your Declaration of Conformity

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