Status of IVDR Implementation 2022

The objective of the IVDR survey was to assess the status of IVDR implementation a few weeks before the effective date. 45 IVD manufacturers participated in the survey. Of these, more than half were small companies with fewer than 50 employees. All risk classes were represented, particularly A (sterile), B and C. The majority of respondents had not yet certified their products under IVDR.

The results show that the requirements are already clear to most companies, but the majority are still in the middle of preparation, very few have started EUDAMED registration and only half have a Notified Body. The most challenging aspects of the IVDR are the timelines, performance requirements and post-market requirements.

Excerpt of the results:

• 60% of respondents knew the IVDR requirements and associated responsibilities "well" and 26% "very well".
• Nearly 85% of companies were still "in the middle" of IVDR preparation; 11% had "not yet started".
• For their clinical data capture, 47% were using Excel, 21% were using paper and 17% were using an EDC ("Electronic Data Capture") system
• 39% of respondents had no support for meeting the IVDR requirements, while 22%
  had support from a testing laboratory, and 10% from a CRO, legal manufacturer,
  and service provider for patent protection, respectively
• 43% did not yet have a Notified Body

For regulatory questions, feel free to contact the TRIGA-S team at  info@triga-s.de.

About Climedo 

Climedo's mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions.Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products.
By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals and patients), Climedo allows for increased performance, better cost-efficiencies - and ultimately - accelerated medical innovation.

Learn more: www.climedo.com.

TRIGA-S

TRIGA-S Scientific Solutions (TRIGA-S) stands for quality and trustful collaboration in clinical and analytical studies for in vitro diagnostics (IVD) since over 20 years. As part of the new EU regulation IVDR, TRIGA-S offers manufacturers tailor-made solutions for performance studies. In addition, they plan and conduct exploratory and feasibility studies. In their in-house BSL2 laboratory, they carry out contract measurements and offer controlled storage and shipping options for human samples and study materials. TRIGA-S is based in Habach, south of Munich, is ISO 13485 certified and was awarded "Bavaria's Best 50" in the SME category in 2020.

Learn more: www.triga-s.de.