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.

Do you like it?0
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.

Do you like it?0
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.

Do you like it?0
October 20, 2021

[Ask the Expert] Performance Evaluation Report

performance evaluation report

This session’s topic: The Performance Evaluation Report (PER)

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance?

During this 45-minute Q&A session, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the role of the State-of-the-Art section within the PER, whether using a PER template is right for you including what the notified body expects to see, and the methodology and strategy for PER, PEP, and PMPF plans.

Who should watch this webinar?

Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission.

Watch the recording!

What You Need to Be Compliant

Watch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section, and explain how it fits into the overall process of writing a successful, IVDR-compliant PER. Additionally, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources, feeder documents, and expertise needed to consider your IVD “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.

Ultimately, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.

Do you like it?0
October 14, 2021

[FEATURED] How The MDR Is Making The EU Competitively Backward

Pedantic versus pragmatic implementation of the EU MDR and its guidances, as well as notified bodies struggling with capacity and new processes, are creating a clunky, slow and expensive EU regulatory system that could damage EU industry, delegates heard at the RAPS Convergence meeting earlier this week.

When it comes to guidances supporting the implementation of the Medical Device Regulation, major issues are being created because there is “no real possibility for industry to actively and meaningly engage in drafting EU guidances” and provide input on how to make the new system work efficiently, Elizabeth Gfoeller, corporate director, regulatory affairs at MED-EL, an EU manufacturer of globally marketed hearing loss solutions, told the first day of the meeting on 13 September.

Do you like it?0