CE mark, CE marking for medical devices
This article describes when and why manufacturers must affix a CE mark, what is meant by CE marking, and what manufacturers must do up to that point.
QM manual: Content and structure
The QM manual is the top document in the document pyramid of the QM system. It is an entry point for employees and auditors to get a quick overview of the QM system. In this article, you will learn when you need a QM manual, its objectives, and what it should contain.
DetailsQuality Management Representative
The Quality Management Representative (QMR) is also called the quality representative or “management representative” by ISO 13485. In this article, you will learn which tasks the person with this role is responsible for within an organization and which regulatory requirements must be observed.
DetailsMDR / IVDR – “Person Responsible for Regulatory Compliance” (PRRC)
Both the MDR and the IVDR require a “person responsible for regulatory compliance” (PRRC). Some people also call them the “article 15 person” (after the corresponding articles in the two EU regulations) or the “qualified person”. The terms “person responsible for compliance with regulatory requirements” (abbreviated to “person responsible”) and “qualified or competent person” are used in German. The “person…
DetailsPMCF studies: three types to be distinguished
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…
DetailsRIMS: Future or anchoring in the past?
Medical 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,
DetailsPFAS ban: You must act immediately!
With 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…
DetailsRegulatory Intelligence – a core task of regulatory affairs?
Many 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.
DetailsDevices without an intended medical purpose – Annex XVI devices
The 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…
DetailsTIR 45: Agile software development for medical devices
The 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…
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