EU Commission Published Summaries of 17 Harmonized EU Standards for MDR and 10 for IVDR

In this Issue

From the Editor ✍🏽 | In-Brief💥 | Featured Interview 🔥 | Sections ✅ | Postscript 🐝

From the Editor ✍🏽

Yesterday, Mario Gabrielli Cossellu posted summaries of 17 Harmonized EU Standards for MDR and 10 for IVDR that were just published this week by the European Commission.

Plus, this week's issue of MLV includes 14 more super-helpful posts, a featured video interview with Ajda Mihelčič, and the Regulatory Roundup by Martin King.

This week's issue of MLV is proudly sponsored by Hoodin.

In Brief 💥

A popular new post from Harsh Thakkar shares 7 books to maximize critical thinking in a QA role.

Sudarshan L S compiled a handy list of 50 commonly used abbreviations in regulatory affairs. (How many did you know?)

A detailed analysis of the FDA’s Premarket Software Submissions Final Guidance by Eric Henry, including the implications of the new guidance.

Brandon Thompson announced some BIG news about a new OTC breast cancer prevention device.

An important new MDCG 2022-18 release was shared by Matt Burton.

Suttons Creek shared a recent article entitled “Creating A Design History File (DHF) That Gets Approval”.

Thanks to Antiksha Joshi for sharing the Top 3 things that frustrate her about change controls.

Vivek Thakkar underscores the importance of terminologies with the FDA.

A summary of changes to the ISO 10993-17:2023 was discussed in a helpful post by Danny Oseid.

Lesley Worthington shared an eye-opening post on compliance and the risks it involves.

A new article entitled “A Systematic Analysis of Recent Technology Trends” was shared by Rucha Natu.

Mike B. Wetherington shared a thoughtful post on saving time and money through market leveraging

A popular post by Ziad Ksouri discusses how machine learning could revolutionize healthcare.

Evangeline Loh highlights the similarities between regulatory systems.

Featured Interview 🔥

Click the image to watch the interview.

Recently, MedTech Leading Voice spoke with Ajda Mihelčič at Obelis Group about "What's Happening Now with EU Device Regulation." Watch this short video for highlights, and read the entire interview soon in MLV.

Sections ✅

✅ Weekly Regulatory Roundup

By Martin King, July 3, 2023.

Click Index to view the Regulatory Roundup.

In This Week's Regulatory Roundup

🔥 New updates from the European Medicines Agency, European Commission, Medical Device Coordination Group, Ministry of Health Sciences Authority Singapore, US FDA, IEC (International Electrotechnical Commission), Medical Device Authority Malasya, Swissmedic, Therapeutic Goods Administration, BSI, International Council for Harmonization ICH, and Egyptian Drug Authority.

Postscript 🐝

Want to sponsor an issue of MLV and reach a growing audience of more than 2.5k of MedTech's most engaged leaders?

🌼 Contact me for introductory "Summer of Love" pricing.

PPS - Please check out last week's sponsor Rochester Clinical Research.

Sean 🐝

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