The Importance of Article 16 of the MDR
Article 16 represents a major advancement in the regulation of parallel imports, providing more clarity and detail than previous regulations. Specifically, it:
- Clearly defines what constitutes a parallel import of a medical device.
- Underscores the critical importance of adherence to essential requirements and harmonized standards.
- Imposes specific obligations on parallel importers, including verification of technical documentation and device traceability.
- Allows for corrective and safety measures to be taken in the event of non-compliance.
