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Johner-Institut

Regulatory Affairs

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Overview

Conformity Assessment: Medical device manufacturers have to prove compliance of the devices by following one of the conformity assessment procedures that are described in the Medical Device Directive / Regulation. Which procedure can be used for which device ...
Harmonized Standards
Technical Documentation: A regulatory compliant technical Documentation (Technical File) is the precondition for any medical device approval. Best practices to pass audits ~
MEDDEV 2.7/1: Revision 4 of the MEDDEV 2.7/1 guideline for clinical evaluations has been in force since 1 July 2016. It offers more detailed assistance than the previous version, but also formulates stricter requirements and surprises with a narrow focus on Europe.
CE Marking: With the CE mark manufacturers of medical devices declare conformity with the respective European directives. Even everybody calls it like this, but there is no CE certification!
Device group: generic device group, device category, device group versus device category, MDR, IVDR, device range,
Data Security and Protection Requirements for Digital Health Applications: The data security and data protection requirements for DIGA (digital health applications) go far beyond the set of questions contained in the DiGAV.
Privacy Shield Agreement: Privacy Shield Agreement: What Its End Means, GDPR, Switching to Amazon's data center site in Frankfurt?, Hosting in Amazon, Google & Co. clouds?
Post-Market Surveillance Plan: Complying with the Requirements of ISO TR 20416: Post-Market Surveillance Plan, Complying with the Requirements of ISO TR 20416
ClinicalTrials Search Mask: Why the ClinicalTrials Search Mask Could Cost You Hundreds of Thousands of Euros
CFDA, NMPA
Marketing Personal Protective Equipment (PPE): Someone who wants to place personal protective equipment (PPE) on the market has to comply with different legislation to someone who wants to place medical devices (MD) on the market.
Regulatory Requirements for Medical Devices with Machine Learning: Manufacturers of medical devices with machine learning are faced with the difficult task of having to demonstrate the conformity of their devices.
The Medical Device File: What You Don’t Have to Include in This File: The Medical Device File, What You Don’t Have to Include in This File, MDR, IVDR, 21 CFR, ISO13485, FDA file, comparison of files
MDR Usability Requirements: MDR, usability, requirements, usability requirement, medical device regulation, mdd, mdd usability requirements, manufacturers
Measuring Function: The ISO 13485:2016 replaces the ISO 13485:2012. Find out more about the differences between ISO 13485:2016 and previous versions. [ROADMAP]
Distributor Requirements: Distributor, Requirements, legal security , manufacturers, mdr, medical device regulation, importer, role
Class 1 Medical Devices
21 CFR Part 11
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.
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 input
Design Change: A design change may require a re-approval respectively re-submission. There are many regulatory requirements related to design changes.
Essential Requirements: Medical devices have to fulfill the "essential requirements" laid down in the medical device directive respectively the "general safety and performance requirements" laid down in the medical device regulations. Get an fast overview here!
GDPR
EUDAMED: EUDAMED, European Database on Medical Devices, is introduced by the Medical Device Regulation MDR. In stores data about medical devices, clinical evaluations etc.
Free Sales Certificates: Many countries insist on Free Sales Certicates (FSCs) to clear medical devices. wWat FSCs are, how to obtain certificates, by whom, and at which costs
Harmonized Standards
IVD Software: IVD Software is standalone Software that is classified as IVD. Learn how to classify and develop the software compliant with IVDR and other regulations.
MDR Rule 11 (Software): MDR's classification rule 11 is a nightmare: It will be a major issue for manufacturers of medical device software. Read what's new and why the EU commission needs to act.
MEDDEV Documents
Notified Bodies: Medical device manufacturers have to involve for approval processes notified bodies. These are companies that evaluate and certify quality management systems on behalf of national authorities.
Periodic Safety Update Report PSUR: The MDR and IVDR require a Periodic Safety Update Report (PSUR) or a Post-Market-Surveillance Report. Tips for implementation!
Post-Market Surveillance: Regulatory Requirements and Tips for Procedural Instructions considering Post-Market Surveillance, Market Surveillance and Vigilance.
Premarket Approval (510k)
Systems & Procedure Packs: MDR and MDD have different(!) requirements with respect to system and procedure packs. When a conformity assessment procedure is required...
Technical File versus DHF: The FDA requires in 21 CFR part 820.30 a design history file (DHF). These is part of the technical documentation, sometimes also referred to as device master record DMR.
Unique Device Identification: The MDR requires a Unique Device Identification for medical devices. It consists of a device identifier (UDI-DI) and a production identifier (UDI-DI).
Physiological processes: It is important to understand what is a vital physiological processes since the classification rules of MDD and MDR depend on this definition.
Medizinprodukte-Durchführungsgesetz (MDG): Article about german Regulation
3D Printing in Medicine: Avoiding Regulatory Traps: 3D Printing, Medicine, Regulatory Traps, Medical Devices
Qualified Person: PRRC, Qualified Person, Person Responsible for Regulatory Compliance, Regulatory Compliance, MDR, IVDR
Request versus Application for Certification
Coronavirus: Coronavirus, China, in vitro diagnostic medical devices, WHO ,Epidemic, pandemic, coronavirus diagnostic , device development
Registration of Medical Devices in Brazil
Regulatory Update: Regulatory Update or How to Stay Up to Date with Regulatory Requirements,certainty during audits National laws, MPG MPDG
Authorization of Medical Devices in Japan: The authorization of medical devices in Japan represents a big challenge for European manufacturers. But it’s not one they should shy away from, because Japan is one of the 10 biggest markets in the world.
Medizinprodukte-Anwendermelde- und Informationsverordnung – MPAMIV: The Medizinprodukte-Anwendermelde- und Informationsverordnung (MPAMIV) replaces the Medizinprodukte-Sicherheitsplanverordnung (MPSV).
Saudi Arabia: Is It Worth Having Your Medical Devices Authorized?: Saudi Arabia, Is It Worth Having Your Medical Devices Authorized?, big market, investments in the healthcare market, Authorization of medical devices
State of the Art: It’s Worse Than You Think: State of the Art: It’s Worse Than You Think, difficult to define, No harmonized standards, Incorrect and inconsistent translations
The Clinical Evaluation Literature Search: The Clinical Evaluation Literature Search, 6 Tips to Save You Time and Stress, MEDDEV 2.7/1 Revision 4, MDCG documents, Literature search protocol
International Medical Device Authorizations: 5 Steps to New Markets: International Medical Device Authorizations, 5 Steps to New Markets, international authorizations, “International authorization” checklist
MDCG 2020-5: MDCG 2020-5: The End of the Equivalence Route for Clinical Evaluations?, Regulatory requirements for equivalence, MDR, equivalence
The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed?: The EU Regulates Medical Laboratories – Are Laboratory Developed Tests Still Allowed?, Laboratory developed tests (LDT), IVDR
Medical Device Consultant: Medical Device Consultant – Only A German Concept?, MPG, MPDG, roles and occupations,Regulatory requirements, Comparison of the requirements