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Author name: EuMe-adm

AI and Data Security: Methods for Detecting Data Leaks in the MedTech Sector

Knowledge & Resources /

With our last LinkedIn article, “Balancing Transparency and Intellectual Property: Obligations of Data Processing Service Providers in the Medical Device Industry”, we were asked about a reliable method to prove data leakage through AI. This is a critical issue, particularly in industries such as healthcare and MedTech, where data security is strictly regulated. Our article focuses […]

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New MHRA Guidance on Digital Mental Health Technologies (DMHT)

Regulatory Updates /

The MHRA has published new guidance on device characterisation, regulatory qualification, and classification: ???? Digital Mental Health Technology – Regulation and Evaluation for Safe & Effective Products This guidance is applicable to Digital Mental Health Technology (DMHT) products placed on the UK market, covering Great Britain (England, Wales, Scotland) and Northern Ireland. It explains the

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MHRA Update: Nanomedicine Decision Tree Released

Regulatory Updates /

On 5 February, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a Nanomedicine Decision Tree—a structured tool designed to guide manufacturers, developers, and regulatory professionals in determining the appropriate regulatory pathway for nanomedicines. This decision tree aims to support researchers and developers in navigating the application of various guidelines from the International Council

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HIPAA Compliance for Medical Device Manufacturers: What It Is and What It Is Not

Knowledge & Resources /

Introduction: Revisiting the Role of Information Security in MedTech In our previous article “The Benefits of Integrating an Information Security Management System to Medical Device Manufacturers,” we discussed the impact of having an information security management system related to compliance with the US Health Insurance Portability Accountability Act (HIPAA). In this article, we will provide

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Free now: Senior Medical Device Specialist – Clinical & Product Development

Knowledge & Resources /

Are you seeking a highly skilled professional to support your clinical and product development projects? A Senior Medical Device Specialist with extensive experience in (pre-)clinical studies, new product development, clinical biocompatibility, and biological safety? With exceptional analytical abilities and a commitment to delivering results on time, our expert is ready to make a meaningful impact

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New PMS Obligations for Medical Devices in Great Britain (2024)

Regulatory Updates /

The ???????????????????????????? ???????????????????????????? (????????????????-???????????????????????? ???????????????????????????????????????????????? ????????????????????????????????????????????????) (????????????????????????????????????) (???????????????????? ????????????????????????????) ???????????????????????????????????????????? ???????????????? introduce new post-market surveillance (PMS) obligations for medical device manufacturers in Great Britain by adding Part 4A, which outlines requirements for monitoring device performance and safety after market introduction. ???????????? ???????????????????????????????????????? ????????????????????????????: ???????????? ???????????????????????? ???????????? ????????????????: Manufacturers must establish a PMS system and develop

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New EUDAMED Q&A published

Regulatory Updates /

The European Commission has released an updated Q&A document on the gradual roll-out of EUDAMED, now accompanied by a helpful flowchart. ???????????? ????????????????????????????????????: Gradual Implementation: EUDAMED modules will be introduced progressively, following independent audits and confirmation of functionality. ???????????????????????????????????? ????????????: Each module becomes mandatory 6 months after the publication of a notice in the Official Journal

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Swissmedic IvDO Amendment 2025: Key Changes for IVD Compliance

Regulatory Updates /

New year starts with amendment of Swiss In Vitro Diagnostic Medical Device Ordinance (IvDO) in order to restore euqivalence to EU IVDR (EU 2017/746). It includes: – Extension of tranisitional provisions for medical device certification – Permanent simplification of mandatory labelling for devices dispensed by professionals – Product registration obligation enters into force at 1st

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Mandatory Reporting for Medical Device Supply Interruptions Starting January 2025

Regulatory Updates /

Manufacturers are obliged beginning from 10th January 2025 to notify authorities in case of discontinuation or interruption of supply of certain medical devices. Which devices? All models or types of devices, placed on the Union market and for which it is reasonably foreseeable that a supply interruption or discontinuation could result in serious harm or

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Amendment of Swiss In Vitro Diagnostic Medical Device Ordinance (IvDO)

Regulatory Updates /

New year starts with amendment of Swiss In Vitro Diagnostic Medical Device Ordinance (IvDO) in order to restore euqivalence to EU IVDR (EU 2017/746). It includes: – Extension of tranisitional provisions for medical device certification – Permanent simplification of mandatory labelling for devices dispensed by professionals – Product registration obligation enters into force at 1st

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