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 ...
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.
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!
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.
Medical devices accessories have to meet the same regulatory requirements as the medical device. However, there are differences, manufacturers should be aware of.
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!
EUDAMED, European Database on Medical Devices, is introduced by the Medical Device Regulation MDR. In stores data about medical devices, clinical evaluations etc.
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'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.
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.
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.
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.