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What You Need to Know About Significant Changes Under IVDR

Co-authored by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation Until recently, many IVD manufacturers were able to make changes to the design or intended use of their devices with minimal consequences under IVDD (98/79/EC). With the transition to IVDR and the date of application just around the corner, that time window is quickly closing. As of 26 May 2022, IVD manufacturers will no longer be able to make changes to the intended purpose or design of a device under IVDD, and all classes of IVDs will be subject to IVDR regulations.
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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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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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webinar | EU | Europe | European Union | EU MDR

EU MDR: Assessing the Impact and Next Steps [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: May 23rd, where discuss MEDDEV 2.7.1 & CERs.
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class iia | EU | disease management | mobile platform | mobile medical applications | health management | FDA | Substantial Equivalence | verizon wireless | software platform | medical applications | software technologies | medical application

Mobile Medical Applications - Most Reliable Apps, Internationally?

A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!
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Japan PMDA | EU | audits | TGA | GHTF | FDA | health canada | quality improvements | iso 13485

FDA’s Guidance Document on Voluntary Submission of ISO 13485 3rd Party Audit Reports

I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.
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QMS | MDD | EU | Canada | Medical Devices | FDA | health canada | 21 cfr 820 | Preventive Action | iso 13485

A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word that is common-place in our society (though, here in Pittsburgh, you'll get a lot of confused looks if you tell someone you've opened a CAPA as it is a local performing arts school. That's a strange nightmare with future Broadway stars re-enacting a root cause analysis!).
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13485 | MDD | EU | Quality Management System | Quality System | Product Quality | FDA | medical device | 21 cfr 820 | Joseph Juran | quality

Architect of Quality – Part 2: The Human Dimension

Welcome to the second installment in our blog series featuring Joseph Juran, “Architect of Quality.”1 Today, we’re going to take a deeper look at one of his major contributions – the addition of the “human dimension” to management theory.
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listing | MDD | EU | Medical Devices | us | gmp | mdufa III | FDA | FDASIA | enforcement actions | registration

Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week:
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MDD | EU | FDA | health canada | medical device | cleveland

Mistake, I Think Not!

As a native Clevelander and lifelong (i.e. 47 years) Northeast Ohio resident, I have heard my fair share of “Mistake on the Lake (Erie)” jokes. Yes, it’s true the Cuyahoga River caught fire in 1969, the city has suffered from loss of jobs due to de-industrialization, there have been numerous failed redevelopment efforts, and as far as sports teams go; well, I have yet to see a championship winning team. Jokes aside, I don’t think anyone can argue that the Northeast Ohio region has evolved into a world class leader in medical treatment, education and innovation in the health care industry.
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MDD | EU | label | Regulatory Affairs | RQS | labeling | ifu | FDA | health canada | medical device | user guide | instructions for use | manual

Labels impact the device

During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.
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Biocompatibility | MDD | EU | Medical Devices | 10993-1 | FDA | health canada | medical device | Medical Device Directive | 10993

Biocompatibility - Simple, Right?

I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device intended use and see that irritation testing, sensitization testing and cytotoxicity testing are required for any new device materials prior to introducing them into the market. Not only did our regulatory folks clearly understand these requirements, but our project teams were also onboard. If engineering wanted to change materials or change the material color or tint, they would contact a toxicologist to perform these three necessary tests. End of story.
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MDD | EU | end user | FDA | health canada | medical device | customer

In Your Face

My teenager works at a local eatery – I thoroughly believe the saying, “A good teenager is a tired teenager”. Besides, there is a lot to be learned from being in the work force.
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medical device innovation consortium | RAPS | off-label promotion | webinar | MDD | EU | mHealth | Medical Devices | mobile medical applications | Training | FDA | scanadu | Pharma | Medical Device Directive | mobile medical apps | US vs. Caronia | Caronia | United States vs. Caronia | qualcomm | x prize

Quick Hits - December 11, 2012

In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:
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MDD | EU | Europe | medicaldevices | medical device | European Union | Medical Device Directives | IVD | medicaldevice | active implantable medical device

Overview of New Medical Device Regulations in Europe

This week my inbox was flooded by notifications of a great blog post from the Emergo group, outlining the changes set to occur to the medical device regulations in Europe. Changes such as:
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occupational safety and health | osha guidelines | MDD | EU | Medical Devices | intuitive responses | design considerations | usability | interaction | occupational safety and health administration osha | environments | FDA | health canada | medical device | occupational safety and health administration | 510(k) | environmental conditions

Mobile Medical Applications: Mobile Medical Device Design

Many medical devices are meant to be used while in mobile situations. These devices could be wearable, carried in a user’s pocket or by hand, pushed like a cart, etc. Users of mobile medical devices expect them to be safe, reliable, durable, and easy to use while in motion or when transported, so let’s look at some design considerations specific to this subset of devices.
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proposals | EU | FDA | CE Marking | European Union | new legislation | FDASIA | September

More changes heading our way?

After a recent statement by the EU health commissioner, it appears that FDASIA's influence may have gone abroad. As the medical device industry gears up and is adapting to the changes that FDASIA brings, it may also have to prepare itself for even more changes heading our way.
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