Overview
- The FDA eSTAR Program: should or must you take part?
- Instructions for Use for Medical Devices and IVDs in the EU
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Medical Device Advertising in Germany and the EU – What is Allowed and What Isn’t
Medical device advertising is generally permitted in Europe, but there are some specific requirements that have to be taken into account. What the UWG, HWG, MDR and IVDR say.
- Substance-Based Medical Devices
- System Architecture
- Digital Health Applications Ordinance
- Conformity Assessment
- Harmonized Standards
- Technical Documentation
- CE Marking
- Device group
- How You Can Meet the Data Security and Protection Requirements for Digital Health Applications
- Privacy Shield Agreement
- Post-Market Surveillance Plan: Complying with the Requirements of ISO TR 20416
- Marketing Personal Protective Equipment (PPE)
- The Medical Device File: What You Don’t Have to Include in This File
- Measuring Function
- Class 1 Medical Devices
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NAKI - The German National Working Group
The National Working Group (NAKI) was created to answer questions on the implementation of the EU regulations, the MDR and the IVDR.
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Accessories for Medical Devices
Medical devices accessories have to meet the same regulatory requirements as the medical device. However, there are differences, manufacturers should be aware of.
- Declaration of Conformity
- Design Change
- Essential Requirements
- GDPR
- EUDAMED
- Free Sales Certificates
- Harmonized Standards
- Laboratory Developed Tests
- MEDDEV Documents
- Notified bodies
- Periodic Safety Update Report PSUR
- Post-Market Surveillance
- Systems & Procedure Packs
- Unique Device Identification
- Physiological processes
- 3D Printing in Medicine: Avoiding Regulatory Traps
- Request versus Application for Certification
- Regulatory Update
- State of the Art: It’s Worse Than You Think
- The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed?
- Medical Device Consultant
- Product Liability
- Code Verifier
- EU Declaration of Conformity
- From a Regulatory Perspective: What Is a Child?
- DVPMG
- Impact of EU Case Law on Standard Harmonization
- MDCG 2020-6: Clinical Data Requirements for Legacy Devices
- Laboratory Products for “Research Use Only” (RUO) – Often a Dangerous Claim
- Companion Diagnostics (CDx)
- What Constitutes the Lifetime of a Medical Device in the EU?
- How Do You Write a Good Definition?
- Combination products
- Radio Equipment Directive (RED)
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EU Data Act
With the EU Data Act, the European Commission has submitted a proposal for a new regulation. It is aiming to create a new legal framework for handling data that won’t just affect the US tech giants but will also affect a lot of companies that process data. Including medical device manufacturers.
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The Health Insurance Portability and Accountability Act
HIPPA is a US law that expands existing laws on data protection and interoperability in healthcare.
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