In 2022-2023, 24 local EU authorized representatives in the Netherlands were examined by the Health and Youth Care Inspectorate (IGJ). 

The main inspection by IGJ was to confirm that the EU complies with the MDR/IVDR obligations.

Check the content

In the examination, the competent authorities will oversee a greater focus on the following three themes:

1) authorized representative agreement between manufacturer and outside the European Union, including the draft agreement signed terms and spot check, etc.;

2) Qualification and experience of authorized representative PRRC (compliance person);

3) authorized representatives to represent the responsibility of the manufacturer, and the manufacturers will medical devices into the European market.

The authorities feedback problem

In the course of the review, for all Odes examined, the main feedback from the competent authorities was as follows:

1) Individual Oems inspected on site, addressed as postal addresses, without the presence of any employees; Authorized representative of the 

work and business place is located outside the European Union;

2) In the case of only one authorized representative employed by the company, this person also acts as the Compliance Officer (PRRC) of Odai. 

In these cases, there is usually no specify if what happens after leave the personnel;

3) The Dutch Medicines Agency has verified the minimum required documents that an authorized representative is required to have. However, 

unable to determine whether the authorized representative to verify the actual file is correct. Therefore, there is uncertainty as to whether the 

medical device actually meets the legal requirements and whether it is effective and safe;

4) the eu authorized representative agreement no uniform version format file; A copy of the agreement without saving; No specific equipment 

name or equipment group is specified in the agreement; Authorized representative agreement is not signed by both sides,

5) the generation of the compliance chief (PRRC) appointment should be prior to the appointed shall conform to the requirements of the PRRC 

experience law of qualifications, not directly with professional working experience during the appointed shall prevail; In addition to the legal requirements, 

the PRRC must have sufficient skills to be able to apply this knowledge appropriately in practice; Eu member states must have at least one PRRC

 (more than one can be weighed according to workload);

6) The authorized representative shall verify the manufacturer's technical documents and DOC, and have corresponding assessment records, and, 

where applicable, indicate that the manufacturer has carried out the compliance assessment procedures; Multiple authorized representatives of 

the same device (group) appeared at the same time.

Summary of SUNGO

According to the inspection, SUNGO Dutch the generation company's audit result is in line with expectations. At the same time, according to the 

official documents, in 2024, the Dutch Medicines Agency will strengthen the supervision of local authorized representatives in the Netherlands, 

which means that the inspection will no longer be limited to the basic requirements of authorized representatives' authorization, PRRC and responsibilities. 

Later we will also strengthen the compliance regulation of manufacturers.