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IVD

RQM+ Executive Video Briefing: IVDR New Transition Timelines

While we are happy and relieved for the IVD industry to have an extension to the IVDR transition period, we’re concerned that the announcement may result in a misperception that there is plenty of time to get the work done.
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IVDR | EU MDR

MDR and IVDR Mock Technical Assessments and Design Examinations

— coauthored by Amie Smirthwaite, BEng, Ph.D., SVP, Intelligence & Innovation and Carlos Galamba, BSc, MSc, VP, Intelligence & Innovation - IVD With the rollout of EU MDR and IVDR, manufacturers are facing new challenges, especially when it comes to technical documentation review. Medical device and IVD manufacturers are accustomed to doing mock audits for quality systems and ISO certification, but these types of assessments are a relatively new concept in the regulatory realm. 
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FDA

FDA CDRH 2021: A Year in Review

By: Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer). Looking back to 2020, as the COVID-19 pandemic gripped the world, much of the FDA’s focus turned to their response to the public health emergency. CDRH in particular reviewed thousands of emergency use authorization (EUA) applications and worked to facilitate the development and availability of COVID-19 tests and collection kits, personal protective equipment (PPE), ventilators, and other devices. Despite this shift in focus, CDRH also received an increase in “conventional” premarket submissions, such as 510(k)s, De Novos, Premarket Approvals (PMAs), Q-Submissions (Q-Subs), and surprisingly even IDEs. Overall, this amounted to a massive 38% increase to CDRH’s premarket submission workload).1
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EU | IVD

The IVDR Performance Evaluation Report

Under the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), every IVD must have a Performance Evaluation Report (PER). PERs consist of three pillars: scientific validity, analytical performance and clinical performance. Collating data to satisfactorily address each pillar must be a priority for IVD manufacturers. With notified bodies under severe pressure and resource limitations, they will not engage with manufacturers who cannot demonstrate that they have processes for IVDR compliance in place.
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medical device

EU MDR Article 61 and equivalence – is there a new way forward?

About this article: Could there be more scope for use of equivalence data under EU MDR than you may have thought? Dr. Amie Smirthwaite, Sr. VP of Global Intelligence & Innovation at RQM+, EU MDR expert, thought leader, and member of the working groups that authored MDCG 2020-5 and 2020-6, has put a lot of thought into MDR Article 61 and the associated requirements around equivalence and sufficient clinical evidence. From the early days of implementing the MDR at BSI until now, five years later, supporting the industry in a consultancy role, Amie has found the wording of this article to be puzzling, creating unnecessary challenges for both notified bodies and manufacturers. Amie and the RQM+ team hope that the position taken in this blog will be food for thought for the European Commission, competent authorities and notified bodies, allowing a bit more flexibility for certifying devices that offer a real benefit to patients.
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medical device | ROW

UK Approved Bodies: on your UKCA mark, get set, go!

The world of medical device regulation has seen immense change in past years. The EU MDR has been at the forefront of every agenda for some time – and the one-year deadline delay provided valuable extra time for businesses to get their act together. That one-year delay also meant that the EU MDR was not implemented into UK legislation before the UK exited from the EU. The UK’s departure from the EU has now added a whole new set of regulatory requirements into the mix. Trading with the UK just got a bit more complicated!
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EU | IVD

Clinical Evidence Requirements Under IVDR

The next key regulatory milestone for manufacturers with products on the European market is the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). A critical stage of IVDR planning is for manufacturers to assess whether they have enough clinical and performance data that meets notified body expectations.
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medical device | ROW

What do we know so far about post-Brexit medical device regulation?

What do we know so far about post-Brexit medical device regulation? With the new European MDR and IVDR regulations at the forefront of every conversation across the medical device industry, the emerging UK regime may have been overlooked as another pending compliance challenge. Yet, the UK’s exit from the European Union (EU) has brought with it a whole host of new regulatory requirements that manufacturers will need to implement if they wish to continue selling their products on the UK market. The Medicines and Healthcare products Regulatory Agency (MHRA) have issued their delivery plan for the UK’s future regulatory framework and have recently launched their public consultation on the future of medical device regulation in the UK. But what do we know so far about the immediate impact on medical device regulation in the UK?
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post market surveillance | medical device | IVD | ROW

Canada Regulations News for Medical Devices and IVDs

In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report, which is similar to the post-market Periodic Benefit-Risk Evaluation Report (PBRER) required for pharmaceuticals in Canada. This new requirement goes into effect on 18 Dec. 2021, which is fast approaching.
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Medical Devices | EU MDR

Impact of of MDCG 2021-24 on the Classification of Spinal Implants

The recently released guidance on classification of medical devices is very concerning for manufacturers with spinal implantable medical devices. MDCG 2021-24 appears to have classified many spinal fusion devices that were previously thought to be Class IIb as Class III. This means a more intense application process, closer scrutiny from notified bodies, and a significant resource investment into reclassification.
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EU MDR

Is Your Medical Device a Well-Established Technology (WET)?

As guidance committees, manufacturers, and notified bodies continue to interpret the EU MDR, some areas remain fuzzy. Well-established technology (WET) is high on the list of definitions that are disputed as notified bodies seem to have a different interpretation than the guidance document. This puts manufacturers in the difficult position of having to decide whether a device is a WET and defending that stance to notified bodies.
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MDR | IVDR | SSCP Requirements | Safety and Performance (SSP)

Overcoming Challenges and Streamlining Your SSCPs and SSPs

In case you missed it, the latest presentation in our webinar series covers the new requirements under EU MDR and IVDR: the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP), respectively. It’s no surprise that manufacturers are finding it challenging to produce these reports because they are completely new to everybody. 
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