Overview
- Substance-Based Medical Devices
- System Architecture
- Digital Health Applications Ordinance
- Conformity Assessment
- Harmonized Standards
- Technical Documentation
- CE Marking
- Device group
- 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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HIPAA in a Nutshell
HIPPA is a US law that expands existing laws on data protection and interoperability in healthcare.
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