The In-Vitro Devices Regulation 2017/746 (IVDR) is a new harmonized regulation introducing a major update of the regulatory framework in the EU. Regulation, entered in force in May 2017, will replace a current EU's Directive and become applicable on May 26th 2022.
New Regulation creates greater transparency, stricter requirements and better traceability of devices, as well as smooth operation of the single EU market for in-vitro diagnostic medical devices. However, the main goal of new Regulation is to ensure a high level of patient's safety taking into account analytical performance and scientific validity of in-vitro diagnostic medical devices on the European market.
Due to the extraordinary circumstances, created by the pandemic situation, and due to the lack of the Notified Body designated and work under the IVDR, the European Commission published on October 14th a proposal for a Regulation delaying the application of Regulation (EU) 2017/746 by three to five years, depending on the risk class of the device.
This proposal was affirmed by European Parliament and European Council on December 21th.
New timeframe for implementation of the IVDR for different risk class devises:
Operating in the international diagnostic market and being a trusted partner worldwide, at DiaSource Immunoassays we are engaged to help and support a patient with best treatment/diagnostics by providing our clients, medical professionals, safe in-vitro medical devices.
What DiaSource is doing to be aligned with IVDR ?
Regulation's additional and heightened requirements have a significant impact on everyday's workload also at DiaSource.
To ensure our products being compliant with the new Regulation, the implementation of improvements into the quality system and the process flow can be seen at any level in the company.
DiaSource is aware that transition from IVDD to the IVDR is a complex and detailed work, therefore all departments are involved into this important process and contribute to the final success.
Which is the implication of company (regarding our TD, QMS, etc) ?
IVDR presents significant change not only to quality management system but also to technical documentation as requirements are stricter. This takes more time for generating a necessary documentation and for approvals to be completed.
New classification rules classified our product in two risk classes – class B (majority of our product) and class C.
Furthermore, new Regulation affects also economic operators and relationship between them, as well as redefine their responsibilities, which has an direct impact on DiaSource partners inside and outside the EU, also ours OEM-in/OEM-out business partners.
- Regulation (EU) 2017/746
- MedTech Europe: Impact of changes under the new EU/IVDR Regulation (EU) 2017/746 to international registrations; 26 May 2020
- European Commission: Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation
- Regulatory Affairs Professionals Society - IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage; 14 October 2021;