on 3 December 2021 | By Nancy Morrison, RQM+
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...
Read Moreon 30 November 2021 | By Nancy Morrison, RQM+
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...
Read Moreon 28 June 2021 | By Nancy Morrison, RQM+
EU IVDR 2017/746 includes a requirement to write a summary of safety and performance (SSP) for Class C and D IVDs. This is a new requirement that wasn’t included in IVDD. The goal of this requirement is to enhance transparency and provide adequate public access to summarized...
Read Moreon 26 May 2021 | By Nancy Morrison, RQM+
The European Union (EU) Medical Device Regulation (MDR) 2017/745 date of application is here! To celebrate the incredible effort medical device manufacturers have put in so far to get to this point, we have compiled a brief review of the remaining EU MDR timeline and a list of...
Read Moreon 20 May 2021 | By Nancy Morrison, RQM+
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...
Read Moreon 18 May 2021 | By Nancy Morrison, RQM+
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.
Read Moreon 28 April 2021 | By Nancy Morrison, RQM+
CE marking is the system used in the EU to indicate that products meet the region’s safety, health, and environmental protection requirements. Products labeled with the CE marking can be freely traded in the European Economic Area without restrictions.
Read Moreon 28 April 2021 | By Nancy Morrison, RQM+
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....
Read Moreon 21 October 2020 | By Nancy Morrison, RQM+
R&Q's August 2020 webinar focused on Economic Operators: Addressing the EU MDR and IVDR requirements head-on. In this follow-up blog post, our knowledgeable MDR and IVDR regulatory experts sat down to answer audience questions.
Read Moreon 27 November 2019 | By Nancy Morrison, RQM+
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...
Read Moreon 4 October 2019 | By Nancy Morrison, RQM+
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...
Read Moreon 18 June 2019 | By Nancy Morrison, RQM+
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...
Read Moreon 16 January 2019 | By Nancy Morrison, RQM+
Hope for the best, but prepare for the worst.
Read Moreon 8 May 2017 | By Nancy Morrison, RQM+
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...
Read Moreon 24 August 2016 | By Nancy Morrison, RQM+
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...
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