Module 17 2024

05/12/2024

Chapter 3: Economic Operators

Obligations of importers and distributors The regulations will introduce a number of obligations on importers and distributors The regulations will also require all economic operators to inform the MHRA if they are aware of any issues that will interrupt supply or cause a shortage of medical devices on the UK market. Qualified Persons Manufacturers will require having available within their organisation at least one Qualified Person with qualifications or regulatory experience that exceeds the minimum standards set out in the UK medical devices regulations. The need for international alignment will be considered in these requirements. SMEs will be required to have a Qualified Person permanently and continuously at their disposal and will not need to directly appoint a Qualified Person to their workforce.

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Chapter 3: Economic Operators

Cases in which the obligations of manufacturers apply to other economic operators The regulations will clarify the circumstances in which an economic operator other than the device manufacturer would and would not be required to take on the manufacturer's responsibilities. They will also outline the requirements that economic operators would need to meet in circumstances where they have modified a device and have not taken on the manufacturer's obligations. However, at this time, there are no details defined. (MDR: Article 16)

The Organisation for Professionals in Regulatory Affairs

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