Discover new articles every week on the topics of regulatory affairs (including international approval and FDA approval), QM systems (e.g., ISO 13485), risk management (ISO 14971), software development (IEC 62304), IT security, clinical evaluation, usability engineering (IEC 62366-1), and systems engineering (including IEC 60601-1, ISO 10993) - also for IVD medical devices.
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EUDAMED is the European database for medical devices. However, it is not only used to manage medical devices. The Medical Device Regulation (MDR) relies on EUDAMED and determines which requirements must be stored in this database. These regulations affect the work of manufacturers and also the work of authorities and notified bodies.
DetailsThis 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.
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.
DetailsThe 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.
DetailsBoth 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 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,
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.
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…
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