As of 26.05.2021, the 93/42/EC Medical Device Directive (MDD), which is based on the CE certification process for Medical Device Manufacturers, was abolished by the European Commission and replaced by the 2017/745/EEC Medical Device Regulation (MDR).
The new Regulation has brought with it many new things or changed the existing studies, especially for safety, clinical and performance, such as Clinical Research, Post-Market Clinical Follow-up, Critical Reporting for Medical Devices, which brought the production of Medical Device Manufacturers.
WHAT SERVICES DOES MEDISMART PROVIDE FOR MEDICAL DEVICES?
Research Protocol Design
Sample Size Calculation
Case Report Form Design
Informed Consent Form Design
Ethics committee and Titck application file preparation
The Site Feasibility and Selection
Planning and Coordination of Investigator Meeting
Site Organization Management
Data Entry Support Service
Electronic Data Entry
Statistical Analysis and Reporting
Medical Writing Procedures
Adverse Events/Serious Adverse Events Monitoring and Collection
According to the current regulation, "medical device",
When used in humans, it does not provide its main function with pharmacological, immunological, or metabolic effects, but can be supported by these effects while fulfilling its function on humans; diagnosis, prevention, monitoring, treatment or alleviation of disease, or diagnosis, monitoring, treatment, alleviation or redress of injury or disability; or The investigation, modification or replacement of an anatomical or physiological function, or Birth control. All kinds of tools, instruments, equipment, software, accessories, including software that are manufactured to be used for its intended purpose, that can be used alone or in combination, that are specifically manufactured by the manufacturer to be used for diagnostic and/or therapeutic purposes, and that is necessary for the medical device to perform its intended function. or other materials.
WHAT ARE THE PRODUCT CLASSES?
Classification references for your device according to Annex IX of the Medical Device directive:
Class I products are low-risk eg external patient protective products. Class I devices supplied sterile are considered Class Is and Class I devices with a measurement function are considered Class Im.
Class IIa, Class IIb devices are medium risk eg Electro medical devices, and implants.
Class III devices are high-risk eg cardiovascular catheters
WHICH PRODUCT CLASSES REQUIRE AN APPROVED ORGANIZATION CERTIFICATE?
All class Is, Im, IIa, IIb and class III devices require Notified Body approval and Medical CE certification. Manufacturers producing these product classes should apply to the Notified Body. Notified bodies for CE Certification can issue product-specific CE certificates for medical products. After obtaining the CE certificate for your medical device, your information will be registered with EUDAMED (EU Databank) and UBB (T.R. Ministry of Health National Data Bank) and you will have the right of free movement in the European market.