R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

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.  

MEDDEV 2.7/1 & CERs: Know the Changes and What to Do [Webinar]

Part of your month, [almost*] 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: July 25th, where we'll discuss cybersecurity (*there will be no R&Q Intelligence Series webinar in June).

EU MDR and Clinical Evidence: What You Need to Know

THE SKINNY: The Council of the European Union adopted the proposed new European Medical Device Regulation (EU MDR) in March 2017 and passed by Parliament in April 2017. It is expected to be published in the Official Journal of the European Union in the upcoming weeks, making the application date mid-2020. The EU MDR will replace the Medical Device Directive (Council Directive 93/42/EEC) and the Active Implantable Medical Device Directive (Council Directive 90/385/EEC). Among the vast changes occurring with this transition from directive to regulation are the new requirements surrounding clinical evidence. If you found the clinical portion of your technical documentation to be challenging in the past, you need to prepare for some additional hurdles.

 

~ Note: This post is just a taste of the detail we'll explore during our R&Q Intelligence Series webinar on EU MDR April 25th at 1:00pm EST. All registrants will have access to the slides and recording from the session.

Register Now

 

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.

MDSAP: A Better Inspection Option for Device Manufacturers?

Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal at R&Q. Jake has more than 20 years of experience working for the FDA. Please join us for a free one-hour webinar on MDSAP, March 28th.

Medical device firms, are you looking forward to your next FDA inspection? I have conducted around 400 of them, and I am still trying to think of an instance when the firm was happy to see me. I never took it personally. FDA inspections can be stressful, not to mention they are very expensive and time consuming to support. Furthermore, FDA inspections are often followed by an unpleasant period of uncertainty regarding outcomes and adequacy of responses.

MDSAP: What is it? Is it for me? How will I get it done? [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: April 25th, where we'll discuss EU MDR.

Review Controls Applied to Outgoing Data Streams (Because the FDA Might Be)

Medical device manufacturers need to carefully manage several important outward streams of information regarding their products. The regulatory community is generally most familiar with the data stream that relates to obtaining clearance to market devices, which involves communications directly with the FDA. The FDA data stream is customarily well integrated with a firm’s internal regulatory functions of review and approval. However, there are other data streams that are critical to the commercial success of device manufacturers.

NEWS: Bill Introduced to Improve FDA's Medical Device Inspection Process

Senator Johnny Isakson [R-GA]

Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal at R&Q. Jake has more than 20 years of experience working for the FDA. We hope his commentary brings a useful perspective to the new bill.

Anytime there is an administration change in the federal government, thoughts turn to potential changes in the regulatory environment. With a Republican chief executive and majorities in the 115th Congress, this year is no exception. On February 15th, Senator Johnny Isakson [R-GA] introduced S.404: a bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.

A Risk-Based Approach to Your QMS Implementation - ISO 13485:2016 and ISO 9001:2015 [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: March 28th, where we'll discuss the Medical Device Single Audit Program (MDSAP).

Acquisition Regulatory Assessments: A Case Study

About R&Q's Case Studies: We hope this Acquisition Regulatory Assessments case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this particular subject? Contact us.


Challenge

Investigating acquired products and associated FDA clearances.

A client took ownership of numerous products they had obtained through an acquisition. Remediation of the regulatory documents was needed, which included a review and evaluation of the 510(k) products to establish whether or not the current marketed products aligned with the existing FDA clearances. R&Q conducted a 510(k) inventory, which required a significant amount of investigation work to compile a list of all applicable products and associated 510(k) clearances, as well as non-filing justification (NFJ) with regard to design changes.

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