EVERBIZ News Center: company news, global medical device regulatory updates, and registration and compliance insights.
192 Plaintiffs Claim EUR 36 Million! The PFAS Storm Is Spreading to EU and US Packaging Compliance
A recent PFAS story from Europe has attracted wide attention. In the “Chemical Valley” south of Lyon, France, 192 residents have sued Arkema and Daikin Chemical France, claiming more than EUR 36 million. Several public reports describe it as one of the most representative PFAS civil lawsuits in Europe. Many companies’ first reaction to such…
Key Points in Implementing Medical Device UDI
In March 2026, the National Medical Products Administration (NMPA) issued two new announcements on the implementation of the Unique Device Identification system for medical devices. Announcement No. 21 (2026) sets out the mandatory timetable for UDI coverage of all device categories and the rules for registration and filing. Announcement No. 15 (2026) provides the detailed…
EU MIR Manufacturer Incident Report Form v7.3.1: What’s New
The European Commission / Medical Device Coordination Group (MDCG) has published the new MIR (Manufacturer Incident Report) form v7.3.1, which becomes mandatory from 1 May 2026. It gives companies clear compliance guidance for completing the form and reduces ambiguity and errors. Alongside MIR v7.3.1, a separate downloadable PDF help document was published, adding extensive field-by-field…
MDR (Regulation (EU) 2017/745) Amending Acts
In March 2026 the EU issued two acts in quick succession that relax clinical investigation and technical documentation assessment requirements for certain products – good news for some Class III and Class IIb implantable medical devices. The first act, C(2026) 1798 final, amends the MDR (Regulation (EU) 2017/745) to extend the list of device types…
Thai FDA Medical Device Registration
Thailand’s imports of medical devices are growing noticeably each year, which fits well with the overseas expansion plans of Chinese medical device manufacturers and exporters. To bring medical devices into Thailand, companies need to understand the local regulatory requirements. The Thai Food and Drug Administration (Thai FDA/TFDA), part of the Ministry of Public Health (MOPH),…
The Interplay Between the MDR/IVDR and the AI Act (AIA)
In June 2025 the EU Artificial Intelligence Board (AIB) and the Medical Device Coordination Group (MDCG) jointly published the guidance document “Frequently Asked Questions on the Interplay between the MDR/IVDR and the Artificial Intelligence Act (AIA)”, reference AIB 2025-1/MDCG 2025-6. It is the EU’s first official guidance that systematically coordinates the sector-specific medical device regulations…
EU Regulations on Clinical Trial Design for AI-Assisted Detection Products
Clinical trial design is the most central and most challenging part of compliance for AI-assisted detection products in the EU. The key requirement is that the trial design must satisfy both the clinical evidence requirements of the medical device regulations (MDR/IVDR) and the additional provisions of the EU Artificial Intelligence Act (AIA) on algorithm transparency,…
Introduction to EU AI Medical Device Compliance
The compliance route for AI medical devices entering the EU market rests on the coordinated regulation of the MDR/IVDR and the EU Artificial Intelligence Act (AIA). This means a device must meet both the safety and performance requirements for medical devices and the trustworthiness requirements specific to artificial intelligence. The EU Artificial Intelligence Act (AIA)…
Medical Device Software Terminology in the EU and the US
The EU and US terminology systems for medical device software both use the core definitions published by the International Medical Device Regulators Forum (IMDRF) in 2013 as their global baseline, but each has developed its own terminology, scope relationships and usage conventions based on its regulatory framework. EU MDSW (Medical Device Software): US SaMD (Software…
GDPR vs the EU Data Act: Similarities and Differences
Regulation (EU) 2016/679, the General Data Protection Regulation (GDPR), has applied in full since 25 May 2018. Most provisions of Regulation (EU) 2023/2854, the Data Act, apply from 12 September 2025. Both are EU regulations that apply directly and uniformly across the entire EU. For the medical device industry, both regulations apply mandatorily to all…
GDPR Data Protection Impact Assessment (DPIA) Template for EU Medical Devices
Chinese manufacturers exporting medical devices to EU countries must meet not only the MDR (EU Medical Device Regulation) but also the requirements of the GDPR (General Data Protection Regulation). The GDPR compliance bar is even higher when processing patients’ health data (special category personal data). Download the EU GDPR text at: https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng. Article 35 of…
The New EU ESPR Regulation Is Here
The New EU ESPR Regulation Is Here: Fully Replacing Ecodesign – Will Every Product Be Affected? For more than a decade, when companies thought of EU product energy-efficiency and environmental rules, the first thing that came to mind was the Ecodesign Directive 2009/125/EC. But from 2024 the EU officially launched a new, more ambitious regulation…