12 months ago we all thought 2020 would be the year of the EU MDR. Little did we know: another acronym carved its name in 2020 history books instead.
So this year, while juggling sudden non-MDR priorities, we’ve all tried to make the most of the MDR bonus year in our own ways. I’ve for example tuned in to as many online events as my headphone-hugged ears have endured learning more about the nuts and bolts of MDR.
Many MDR nuances have become clearer to me! That’s why I’d like to share with you some of the webinars I’ve watched in 2020 that are still easily available online. I believe they would help anyone out there entering 2021 as an MDR rookie trying to build MDR understanding fast or as a more experienced professional ready to raise her/his MDR game.
Let’s get started.
Tip – Click on the headlines below to open the webinar links.
1. How to write SSCPs that reach your target audience
Under the MDR, manufacturers of implantable and class III medical devices are required to add a few new documents to their repertoire. One of them is called Summary of Safety and Clinical Performance (SSCP). SSCP needs to be updated whenever the annual update of the Post-Market Clinical Follow-Up (PMCF) evaluation report and the Periodic Safety Update Report (PSUR) affects SSCP as well.
What makes SSCP so fascinating is that its target audiences are both healthcare professionals and patients who are directly using the device. Manufacturers probably need the help of writers who have strong technical writing skills and writers who can turn complex scientific information into user-friendly content.
This webinar by Qserve is essential if you want to get a better understanding of what SSCP is and know which practical steps to take when attempting to write a clear, notified body-, health care professional- and patient-friendly SSCP (phew, it’s friendly in here!).
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2. EU MDR prep: Translation requirements that will make or break your devices in Europe
The MDR enforces lots of language and translation requirements to documentation, labels and quality assurance of medical devices. They impact not only manufacturers, but distributors and importers as well. They all need to be aware of what MDR requires and what each Member State expects.
You shouldn’t miss this webinar by RAPS if you want to make sense of MDR requirements for language and translation and how they’ll affect your company’s multilingual content and QMS.
Note – for RAPS members the webinar is free; others can access it for just 20 dollars.
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3. Clinical evaluation under the MDR – Do you understand the requirements?
With Christmas just in the rear-view mirror, I can only say that Clinical Evaluation feels like a gift that keeps on giving. Whenever I think I’ve seen it all (“I can totally tell CEP, CER, CDP, SSCP, PSUR and PMCF apart”, “This time state-of-the-art won’t fool me”), I realise (like during this webinar) there is yet another devil in the detail!
But no worries, I’m completely blissful and joyful that BSI organised this webinar to sharpen my (and anyone else’s) understanding of the clinical evaluations under the MDR. BSI walks you through the clinical process and evaluation not only from MDR and MDCG perspectives, but also from a notified body’s angle. Sounds like a late Christmas present you really should open, right?
Tip – Fill in your contact details on the webpage and tick MDR to access this webinar.
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4. How the MDR impacts the QMS? Beyond the obvious aspects we already know
Certain parts of the MDR, such as technical documentation, risk management, clinical evaluation and post-market surveillance have become quite familiar to most of us. But beyond them, how well do we really know the MDR and the effect it has on the QMS? For example PRRC, traceability, website requirements and device registrations.
In this webinar, Qserve provides a much appreciated reminder (or even a wake-up call to some?) on the many lesser known MDR components which impact the QMS. Even if you think you know all about how QMS will be affected by the MDR, I dare you to watch this webinar and see for yourself how many boxes of your soon-to-be MDR-compliant QMS checklist you can tick at the end.
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5. Update your medical device UDI data & labels-This year FDA class I | Next year EU MDR
While the Unique Device Identification (UDI) is well-known to those involved in the medical devices business in the US market, here in the EU it is still mainly in the learning phase. And learning we must do to be able to understand and follow MDR UDI requirements: how to create the UDIs, update medical device labels and documents the right way, and upload correct information to EUDAMED.
Reed Tech’s webinar lays down the UDI specifics clearly and gives a chance to compare the US and EU UDI. Always good to get perspective! The webinar provides plenty of examples and resources to help you take the next step.
Tip – Once on the webinar page, fill in your contact details and submit to access the webinar.
Did you watch any of these webinars in 2020?
If you did, did you find it/them valuable like I did?
Or do you have other favourites that you’d like to share in the comments below?
As always, if you’re looking for someone to help you find answers to any MDR question circling in your head, please get in touch – I’d be happy to help.
