Month: May 2023

EU Parliament

MDR Extension: Notified Body Confirmation Letter

The European Commission (EC) has released a “Confirmation Letter” detailing recent amendments to the Medical Devices Regulation (MDR). This document, titled “Template for NB – Confirmation letter in the framework of Regulation (EU) 2023/607,” has been eagerly awaited by medical device manufacturers, the industry, and healthcare providers. This confirmation letter is pivotal following the changes …

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EU Parliament

SCHEER Phthalate Guidance Updates

The European Commission has tasked its Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) with revising guidelines related to the assessment of specific phthalates in medical devices. This applies to phthalates with harmful properties such as being carcinogenic or endocrine-disrupting. Manufacturers, dealing with the requirements of General Safety and Performance Requirement (GSPR) 10.4.3 of …

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EU Parliament

New Guidance: Summary Clinical Investigation Reports

The European Commission (EC) has recently issued vital guidance (2023/C 163/06, dated May 8th) concerning the summary of clinical investigation reports, as mandated by Article 77(6). Manufacturers embarking on or planning clinical investigations must strictly adhere to the European Medical Devices Regulation (MDR) 2017/745, Declaration of Helsinki, and EN ISO 14155:2020. According to Article 77, …

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