Last November 2020, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2020-16 “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746” to explain what are the classification rules of IVDs according to Annex VIII of the IVDR.
MDCG 2020-16: seven classification rules of IVDs for four risk classes
The document is an important guide for stakeholders in the field of in vitro diagnostics, as the Regulation IVDR (EU) 2017/746 introduces a new classification system based on rules that will subject IVDs to a higher control level.
In fact, Art. 47 of the IVDR establishes four new risk classes (A, B, C and D) for in Vitro Diagnostic Medical Devices depending on the intended use of the device and the risks associated with its use.
Compared to the previous Directive IVD 98/79/EC (IVDD), the classification of the devices is one of the most significant changes of the new provision and, for this reason, it is necessary to analyse carefully the seven classification rules of IVDs included in Annex VIII of the IVDR.
According the latest statistical projections, almost 85% of the IVDs in self-certification under the IVDD will require the intervention of a Notified Body under the IVDR and many Manufacturer will have to face the certification process for the first time. This will be a real challenge, considering the novelty of the implementation, the low number of Notified Bodies available and the timing of transition.
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Thema offers strategic-regulatory consulting services to companies that produce or distribute Medical Devices (MD) and in Vitro Diagnostic Medical Devices (IVD).
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For more information on the IVDR (EU) 2017/746, see also In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746: main changes