PMCF studies are studies that manufacturers use as part of Post-Market Clinical Follow-up (PMCF) to continuously demonstrate compliance of their medical devices. Manufacturers do not always need to conduct studies to meet PMCF requirements. And not all types of PMCF studies are subject to MDR requirements. This article compactly summarizes the regulatory requirements in the…
DetailsMedical device manufacturers have high expectations of Regulatory Information Management Systems (RIMS). The costs and efforts involved are immense and usually much higher than expected. The benefits, on the other hand, are not clear. This article will give you some hints, 1. Definition: RIMS 2. Goals of RIMS Pharmaceutical and medical device manufacturers expect several…
DetailsThe EU regulations the MDR and IVDR set out precise requirements for importers. And they also define who is an importer. Bringing a device into the EU does not always constitute an import. And, furthermore, companies that import medical devices don’t just have to meet the requirements established for importers. 1. What is an importer?…
DetailsWith PFAS, the EU plans to ban an entire class of chemicals. In doing so, it is not only threatening the supply of medical devices but also the competitiveness of EU manufacturers. After all, the assumption that manufacturers inside and outside the EU are treated equally is just one of the EU’s five misconceptions in…
DetailsMany companies consider Regulatory Intelligence so important that they create their own roles and departments for it. This article clarifies what Regulatory Intelligence is, how companies can benefit from it, and where tools can provide support. 1. What is “Regulatory Intelligence”? This includes gathering and analyzing regulatory information from various sources, including regulatory agencies, industry…
DetailsThe EU Medical Devices Regulation (MDR) regulates not only medical devices but also devices without an intended medical purpose, e.g., liposuction devices, breast implants, and colored contact lenses. In December 2022 – four and a half years after the MDR was published – the EU regulated the necessary details with two Commission Implementing Regulations (2022/2346 and…
DetailsASCA stands for Accreditation Scheme for Conformity Assessment. The procedure is intended to accelerate conformity assessments and, thus, approval procedures. However, it is not applicable to all devices or all markets. This article explains who benefits from ASCA and how the procedure works. 1. ASCA – The basics a) Who is affected by ASCA? ASCA…
DetailsThe TIR45 (“Guidance on the use of AGILE practices in the development of medical device software”) is a Technical Information Report (hence TIR) of AAMI, the Association for the Advancement of Medical Instrumentation. First published in 2012, TIR45 has one primary objective: To guide medical device manufacturers on developing software compliant with FDA requirements while…
DetailsTrend analysis is a legal obligation of all medical device manufacturers, especially in “Post-Market Surveillance.” Manufacturers must not fail in the selection and application of suitable statistical methods for trend analysis. This is because the focus of authorities and notified bodies is increasingly shifting to monitoring post-market activities. This article provides a quick introduction to this…
DetailsThe term “medical device PC” is not clearly defined. However, most people understand a medical device PC to be Depending on the constellation, manufacturers must fulfill different regulatory requirements. These are presented in this article. 1. Case distinctions for medical device PCs Case A: Standalone software is delivered If you as a manufacturer only supply…
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