November 16, 2021

[FEATURED] Latest European Commission Figures Suggest One More IVDR Notified Body In Pipeline And Then A Gap

The European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.


The urgency of having the necessary structures in place, including notified bodies, so that manufacturers can comply with the IVD Regulation, continues to be emphasized by all stakeholders in the EU IVD sector.

Accompanying this is a general sense that there has been a lack of transparency about when additional designations will be made, which hinders companies’ preparations.

The latest figures from the European Commission show that progress is being made, but not as quickly as the sector would like.

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November 8, 2021

[FEATURED] EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due ‘By December’

The EU Medical Device Regulation applied in May, but the 200 or so associated standards that support it remain in the early stages of preparation. A few have been issued, and now industry can expect a small second wave later in 2021.


In a best-case scenario 61% of today’s IVDs will be certified by the 26 May 2022 IVD Regulation deadline, and in a So far, only five standards have been published in the Official Journal of the EU in the context of the EU’s Medical Device Regulation, and four in the context of the IVD Regulation.

But more standards are due to be officially published this year, including the European versions of the international quality system standard EN ISO 13485 and of the risk management standard EN IS0 14971, standards that are the very foundation of the implementation of the MDR and IVDR but which are now going to be officially available later than the originally anticipated October deadline.

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November 2, 2021

[FREE WHITE PAPER] Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness

Overview

This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review (SLR) process and take a wholistic approach to conducting an In Vitro Diagnostic Regulation (IVDR)-compliant SLR.

Leveraging published data can help meet global regulatory expectations, fill knowledge gaps, and inform internal decision-making. This applies to IVDR and Medical Device Regulation 2017/745 (MDR) requirements, but for the sake of providing an example, we focus on IVDR here. A methodologically-sound SLR can leverage published data for critical IVDR-required reports (e.g., the Scientific Validity Report, clinical performance). Remember, an SLR is far more than an internet search. It is a clear and robust plan for the identification, retrieval, selection, appraisal, and weighting of published data. SLR has long been the “gold standard” process for evidence-based research, especially in the academic and professional arenas. In today’s regulatory landscape where rigorous methodological SLR principles are now being mandated, adopting a transparent and reproducible process for literature reviews is essential. Every methodologically-sound SLR has 5 clearly defined steps…

Download the rest of this white paper here.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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November 1, 2021

[FEATURED] EU Is Heading For Partial IVD Market Collapse, Recent Analysis And Figures Suggest

With just six notified bodies designated under the IVD Regulation, and amidst repeated warnings of insufficient auditing capacity, the EU could lose between three-quarters and over a half of its IVDs, a recent survey warns.


In a best-case scenario 61% of today’s IVDs will be certified by the 26 May 2022 IVD Regulation deadline, and in a worst-case scenario only 24% will be, a survey recently conducted by EU medtech industry association MedTech Europe found.

The conditions for this crisis situation have mainly arisen because, while just 8% of IVDs need a notified body certificate under the currently applicable IVD Directive, 78% will need notified body involvement under the IVDR. That is according to the organization’s latest estimates.

The biggest loss, it predicts, is likely to come from SMEs who make niche products in smaller volumes and who may be less able to endure loss of business, MedTech Europe says.

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October 25, 2021

[FEATURED] European Commission Gives In On IVDR Delays: Proposal For New Transition Periods

The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.


The European Commission has proposed a “progressive” roll-out of the new IVDR to prevent disruption in the supply of IVDs.

While the IVDR will fully apply on 26 May 2022, as expected, there will be a tiered system allowing many products a grace period before they have to be fully compliant with the regulation.

Under certain circumstances, as cited below, Class D higher risk IVDs, such as HIV or hepatitis tests, would have a transition period of three years, until May 2025, while class C IVDs, such as certain influenza tests, would not have to be compliant until May 2026, according to a proposal issued on 14 October. Lower risk IVDs, meanwhile, such as class B and A sterile devices, would not have to be fully compliant until five years later than the current deadline of May 2027.

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