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MDR | EU MDR

Optimizing your Technical Documentation to reduce NB review time and questions (Medical Devices and IVDs)

Whether you are used to working with a notified body or the MDR/IVDR requirements no longer allow you to self-certify and it’s all new to you, it is more important than ever to optimize your technical documentation. Notified bodies are already swamped with MDR submissions, and as the IVDR deadline approaches and new manufacturers engage them, the bottlenecks will get even tighter for IVD NBs.
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CE Marking

How to Obtain CE Marking Under the MDR

In the EU, CE marking is the system used to demonstrate that products meet the region’s requirements for safety, health, and environmental protection. When a product is labeled with the CE marking, it can be freely traded in the European Economic Area (EEA) without restrictions. 
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SSCP Requirements

8 Lessons Learned After Writing the Summary of Safety and Clinical Performance (SSCP) using MDCG 2019-9

EU MDR 2017/745 includes a requirement to write a summary of safety and clinical performance (SSCP) for implantable and Class III devices. Although this is still a relatively new requirement, RQM+ has already gained valuable experience preparing SSCPs on behalf of our clients. If you’re starting the process of creating your SSCPs, this post covers the basics and some lessons learned from our own experience.
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News

BREAKING NEWS: EU MDR Delay Class I Devices

RQM+ clients have one more thing to be thankful for this year as a new Corrigenda to the European Union Medical Device Regulation (MDR) has been issued that extends the due date for Certificates for Class I – reusable surgical instruments – for four years. Check out the newly released document here (English translation begins on page 44). The key message from this document is that if Notified Body involvement is required for a Class I device and the device is on a Declaration of Conformity by May 26, 2020, then it can remain on the market under certain conditions until May 26, 2024. Other Class I devices that have a Notified Body certificate (sterile or measuring) may remain on the market if they have a valid certificate from a Notified Body. In order to take advantage of this extension, the devices must meet the following conditions: 1. Must be on the Declaration of Conformity by May 26, 2020 for the Medical Devices Directive (MDD) 2. Must continue to meet the requirements of the MDD 3. No significant changes in design 4. No significant change in the intended purpose 5. Must follow EU Medical Device Regulation (MDR) post-market surveillance (PMS), vigilance and registration a. Note that starting on May 26, 2020, registration is affected by the European database on medical devices (EUDAMED) delay until May 26, 2022 Keep in mind that the corrigenda has a limited scope and does not extend other deadlines! RQM+ experts will continue to keep an eye on this breaking news and provide updates on our blog as we learn more.
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News

"Hope isn't a strategy." Takeaways from RAPS and new industry updates.

September was an incredible month for us at R&Q. Our thought leaders were out and about at DeviceTalks Minnesota, our own 3-hour CER Virtual Workshop (now available on demand), The MedTech Conference (AdvaMed), and the RAPS Regulatory Convergence. Whew! If you participated in any of these events with us, thank you, and we hope you walked away with actionable information and your questions answered. If you're reading this you're well aware our industry is always changing and in order for our subject matter experts to always deliver industry-leading consulting services, we need to stay on top of changes... and that's exactly what we do. We know "hope isn't a strategy," as someone so aptly put it at the RAPS Regulatory Convergence. This post is a short recap of major takeaways from the RAPS Regulatory Convergence and recent industry updates. After reading this post there's a better-than-average chance you may have questions. We encourage you to ask anything here and consult our free  webinars for more information.
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News

Two sides of the regulatory coin

One of the most rewarding aspects of regulatory work is that no two days are the same. There are always new (and constantly evolving) technologies and regulations to provide fresh opportunities to show your skills. If you’ve been tied up trying to get ready for May 26, 2020 and missed the new documents published in the last month, we thought we'd provide you with a short summary of what has been published recently. As we at R&Q well know, the other side of the [rewarding work] coin is that it can be awfully challenging to keep up! We hope you find this helpful and if you'd like to see more posts like this, definitely let us know.
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News

What does Brexit mean to your medical device company?

Hope for the best, but prepare for the worst.
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IVDR | EU MDR

RESOURCE: The MDR and IVDR Have Been Published! See Our Table of Key Dates

Publication in the Official Journal of the European Journal on May 5, 2017 means the regulations will enter into force on May 26, 2017, twenty days after publication. We will have a three-year transition period for the MDR and a five-year transition period for the IVDR. Products can be issued a certificate under the MDD with a full five-year expiry for the first two years of the transition period but should comply with all other aspects of the MDR in May, 2020. Since most IVD products are currently on the market as a self-certified they will require certificates by the end of the five-year transition period where most products now require Notified Body involvement.  
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News | FDA | 510(k) submission | regulatory news | compliance | 510(k)

What You Should Do About the Two New FDA Draft Guidance Documents

It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, 2016 it finally happened! For those of you who remember the FDA's attempt at updating the 1997 Memorandum in 2011, that draft guidance was met with general industry pushback, congressional input, an FDA report to congress, and now a new draft guidance.
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