As we all know, to place an In Vitro Diagnostic (IVD) device in the European Union (EU) market, manufacturers must abide by the EU IVD Regulations (EU IVDR) 2017/746. One of the key requirements of the IVDR cycle is performance evaluation. The objective of performance evaluation is to demonstrate that the IVD is safe and effective to use, and at the same time, it is aligned with its intended use. The performance evaluation of in the IVD begins with the devising of a Performance Evaluation Plan (PEP).

The European Notified Bodies (NBs) have published a new position paper to address the concerns of MDR/IVDR designated NBs. It will be effective from May 26, 2022 to May 26, 2024. The MDR/IVDR regulations aim to improve patient safety by strengthening the requirements for manufacturers and NBs.

The Medical Device Coordination Group (MDCG) has recently published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices Regulation 2017/745 (IVDR). It is well known that the IVDR is expected to come into force later in May 2022. As the IVDR implementation sets specific challenges for the stakeholders, the European Commission (EC) and the Member States, the MDCG reviewed the relevant inputs from all the stakeholders and established a joint implementation plan.

Many Medical devices and Invitro Diagnostic (IVD) manufacturers gain market authorizations or device approvals in Australia using the conformity assessment certification issued by the EU Notified Bodies.

Below are the various factors affecting or impacting device registration in Australia.

It is a known fact that the European Union’s In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will be in effect from May 26, 2022 and IVD manufacturers have to be prepared to implement the mandatory Regulatory requirements for this transition. This new regulation requires manufacturers to demonstrate appropriate levels of clinical evidence to gather the right clinical data based on the class of the IVD, intended purpose, the software involved and whether the software is independent or combined or an accessory?

In the light of the international health crisis, on April 17, 2020, the European Commission (EC) proposed a one-year delay in the adoption of the new European Union Medical Device Regulations (EU MDR). Originally, the set of regulations were supposed to come into force by May 26, 2020. Considering the current global scenario and the shortage of devices and other medicinal products, the EC deemed it necessary to focus on ensuring the adequate supply of devices, as usual, instead of stressing more on the transition of the EU MDR.

With each year, Life Sciences industry is transforming in unpredictable ways, of course it is to better the end-user’s safety. The industry is progressing with technological advancements and the health authorities are equally striving to upgrade the existing Regulatory frameworks to align with market requirements. The Agencies are considering the industry point of view, too, to simplify the regulations. We have seen many such regulations in 2018. But what’s there in 2019?