{"id":3710,"date":"2023-09-06T05:40:00","date_gmt":"2023-09-06T05:40:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=3710"},"modified":"2025-11-14T04:59:18","modified_gmt":"2025-11-14T04:59:18","slug":"medical-devices-usa-europe-regulatory-news-september-2023","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/medical-devices-usa-europe-regulatory-news-september-2023\/","title":{"rendered":"Medical Devices-USA\/Europe Regulatory News-September 2023"},"content":{"rendered":"\n<\/span>

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USA (FDA)<\/h3>\n\n\n\n

Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors<\/strong><\/p>\n\n\n\n

The FDA has released guidance designed to support institutional review boards (IRBs), clinical investigators, and sponsors in meeting the agency\u2019s requirements for informed consent in clinical investigations. The document outlines core regulatory expectations, clarifies the responsibilities of relevant parties, and provides answers to frequently asked questions. <\/p>\n\n\n\n

The FDA emphasizes that informed consent is more than obtaining a signature. It is an ongoing process in which potential participants\u2014or their legally authorized representatives\u2014receive sufficient information, are given the chance to ask questions, and voluntarily agree to take part. Investigators must continue to offer updated information throughout the study as needed.<\/p>\n\n\n\n

Use of Off\u2011The\u2011Shelf (OTS) Software in Medical Devices<\/strong><\/p>\n\n\n\n

This guidance describes the documentation FDA recommends including in premarket submissions for medical devices containing off\u2011the\u2011shelf (OTS) software. The intent is to streamline FDA review and outline the minimum information typically generated during software development, verification, and validation. <\/p>\n\n\n\n

The term \u201cpremarket submission\u201d includes 510(k) notifications, De Novo requests, PMA applications, IDE submissions, and HDE applications unless otherwise stated.<\/p>\n\n\n\n<\/span>

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EUROPE<\/h3>\n\n\n\n

MDR and IVDR Communication Survey<\/strong><\/p>\n\n\n\n

An online survey has been launched to gather insight into stakeholders\u2019 information needs related to the MDR and IVDR. The goal is to understand how the regulatory changes are affecting stakeholders and identify challenges they face during the transition period.<\/p>\n\n\n\n

Flowchart on MDR Transitional Provisions<\/strong><\/p>\n\n\n\n

A new flowchart has been published to help manufacturers and other actors determine whether their device qualifies for the extended transitional period under Article 120 of Regulation (EU) 2017\/745 (MDR), as amended by Regulation 2023\/607. The tool helps determine eligibility, required conditions, and associated deadlines. Users should consult the MDR text and corresponding Q&A for full legal clarity.<\/p>\n\n\n\n<\/span>

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Czech Republic (NISZP)<\/h3>\n\n\n\n

Information Sheet for Non\u2011EU\/EEA Authorities<\/strong><\/p>\n\n\n\n

Manufacturers outside the EU intending to market devices in the EU must understand the timelines and obligations under MDR and IVDR. During the transition period, legacy Directive\u2011compliant devices and Regulation\u2011compliant devices will coexist. This is especially important for third countries that rely on CE marking for market entry.<\/p>\n\n\n\n<\/span>

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Latvia (ZVA)<\/h3>\n\n\n\n

New Medical Device Regulations Implemented<\/strong><\/p>\n\n\n\n

On 23 August 2023, Latvia introduced Cabinet of Ministers Regulation No. 461, aligning national requirements with MDR (EU) 2017\/745. The previous 2017 regulations on registration, conformity assessment, distribution, and supervision are now replaced.<\/p>\n\n\n\n

Rules for Clinical Studies and IVD Performance Studies<\/strong><\/p>\n\n\n\n

Also effective 23 August 2023, Regulation No. 455 establishes procedures for clinical studies involving medical devices and performance studies for IVDs. These rules implement obligations under MDR 2017\/745 and IVDR 2017\/746 and replace the earlier 2010 clinical research procedures.<\/p>\n\n\n\n<\/span>

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Poland (URPL)<\/h3>\n\n\n\n

Notice on Provision of IVD Devices to Lay Users<\/strong><\/p>\n\n\n\n

Poland clarified restrictions under national law implementing IVDR (EU) 2017\/746. Non\u2011self\u2011testing IVD devices, except sample containers or general laboratory products, may not be supplied to laypersons. Violations may result in fines up to PLN 250,000. <\/p>\n\n\n\n

Only IVD devices explicitly intended for self\u2011testing and certified by a notified body\u2014with proper CE marking, notified body number, and labeling in Polish\u2014may be provided to non\u2011professional users.<\/p>\n\n\n\n<\/span>

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Slovakia (S\u00daKL)<\/h3>\n\n\n\n

Issuing Free Sale Certificates (FSC)<\/strong><\/p>\n\n\n\n

As of 1 August 2023, S\u00daKL may once again issue FSCs for medical device and IVD manufacturers or authorized representatives based in Slovakia, following amendments to Act 362\/2011.<\/p>\n\n\n\n

Temporary Amendments to Act 362\/2011<\/strong><\/p>\n\n\n\n

The amendments define requirements for clinical testing and performance studies, as well as rules for handling medicines and devices during crisis situations. They also clarify definitions related to placing medical devices on the market.<\/p>\n\n\n\n<\/span>

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Switzerland (Swissmedic)<\/h3>\n\n\n\n

Swissdamed \u2013 Swiss Database on Medical Devices<\/strong><\/p>\n\n\n\n

Swissmedic is developing Swissdamed, an IT platform for managing medical device and IVD regulatory requirements. The system will feature:<\/p>\n\n\n\n