With regard to compliance costs for industry, the regulatory impact states that additional costs are only to be expected if the competent authorities make use of the sampling instrument. Furthermore, the possible additional costs are classified as marginal. However, this does not include the indirect costs incurred by industry due to the provision of experts in the course of inquiries and inspections by the authorities.
The individual regulations
Re § 3 Principles of monitoring
The VDGH welcomes the annual plans to be drawn up in accordance with Article 88(2) IVDR. It is suggested that the annual summary, review and evaluation of activities should also be made available to the industry, especially as long as the referenced electronic system EUDAMED is not fully functional.
The VDGH proposes that the associations be informed in a letter about the publication of the report, for example on the website of the state authorities or the central coordination office in accordance with Section 4.
Re § 5 Quality assurance system
Organizational and personnel framework conditions are essential for proper and harmonized monitoring. The VDGH therefore welcomes the continuation of a quality assurance system, in particular the clear definition of the content of procedural instructions and other QA documents in accordance with paragraph 2 point 3 and the publication on the website of the coordination body in accordance with paragraph 3.
The publication of the procedural instructions in accordance with paragraph 3 should not be limited to the procedures for the performance of inspections in accordance with § 8 and the verification of products in accordance with § 9, but should, in the interests of harmonization, cover the entirety of the quality assurance system and extend across the entirety of the procedural instructions (letters a-i of paragraph 2 no. 3).
For a harmonized implementation of Article 92 IVDR, it must also be clarified in which procedural instructions the handling of "minor non-conformities" is included.
Re Section 7 Expertise of the persons responsible for monitoring
The additional legal university or university of applied sciences training included in paragraph 1 point 1 is to be welcomed in principle.
In the interests of harmonization throughout Europe, the VDGH supports the opportunity mentioned in paragraph 2 for professional training at European level in the form of professional training measures, joint workshops and internships with other competent authorities as well as joint inspections with persons from other authorities and exchanges of experience.
Re § 8 Performance of inspections
The introduction of possible remote inspections is appropriate and is welcomed.
