Last Updated on March 20, 2023 by BIOMEDRIC
Directive 97/79/EC of the European Parliament, which is the current regulation before EU IVDR 2017/746, includes the Union regulatory framework regarding in-vitro diagnostic medical devices. In-Vitro Diagnostic Directive particularly directs the safety, superiority, performance, and precautions associated with the in-vitro diagnostic medical devices. The main aim is to make sure the health and safety of the patients are not put at any risk due to the quality factor of the in-vitro diagnostic medical devices. However, a radical revision of the Directive is expected for establishing a vigorous, explicit, and foreseen legal framework for the in-vitro diagnostic medical devices for the purpose of offering a supreme level of health and safety along with considerate improvement.
EU IVDR 2017/746 is the contemporary regulation of the European Union which focuses on the in-vitro diagnostic medical devices in the European markets. The idea for the new regulation was actually brought up on the 5th of May 2017 and is expected to come into force from the 26th of May 2022. Many rules and regulations were updated to provide the topmost health care and well-being to the people.
In-Vitro Diagnostic Directive vs. In-Vitro Diagnostic Regulation
On comparing In-Vitro Diagnostic Directive (IVDD) and In-Vitro Diagnostic Regulation (IVDR), the most significant changes seen are in the up-gradation of safety and quality of in-vitro diagnostic medical devices also the opacity of the information is reduced to be more transparent. IVDR offers an improved oversight and a far better ability to provide accommodation to new scientific inventions and technological changes; the scope of IVDR is comparatively massive, it is expected to include software diagnostics. In addition, in IVDR grandfathering of any medical device is no longer an option, so every device is supposed to be re-evaluated in consideration of the probability of the risk.
In IVDR several new rules and regulations regarding the classification of substantial devices have been framed. But the classification system as a whole has not completely changed. All the medical devices containing substances that are supposed to be absorbed or have to be let in the human body will have to depend on a drastically changed classification system.
Notified bodies that are authorized for evaluating the medical devices will also be affected under IVDR. They may be subjected to losing their assigned posts or may be made responsible for working on a different task. Now, the job of the Notified Bodies will be of increased responsibility as they have to be in close touch with the European Commission for the clinical testing and also carry out surveillance assessments. Their requirement has become comparatively stringent. However, same as the prior format under IVDD the notified bodies are still responsible for assessing the higher class of medical equipment and devices.
Preclinical, Clinical and Post-clinical Stages
- Preclinical evidence of in-vitro diagnostic medical devices mainly includes scientific validity and analytical validity. The basic step for the scientific validity is to comply with the physiological state or the disease. The risk associated with the usage of the device should be given utmost importance. For the analytical validity, the appropriate method has to be used to rely on the measurements.
- Clinical evidence stating the clinical performance and utility of the in-vitro diagnostic medical devices should support the intended aim of the device as mentioned by the manufacturer.
- The reactive and proactive post-market surveillance ensures that the devices continue to meet the same quality, safety, and performance requirements as when they were first released to the market.
BIOMEDRIC Support for IVD Medical Device Manufacturers
BIOMEDRIC has hopped on to adopting the new rules. Under IVDR, quality and safety have been given the utmost focus and post-market surveillance also guides to gather and analyze all the data during the functioning period of the medical device. This benefits the manufacturer for monitoring CAPA actions and procedures for all the medical devices.
The life-cycle management and continuous evaluation of the products are the key emphases of IVDR. So, all the leading medical agencies should adopt the new regulations. All the advanced, safe, and quality services with the new technology are the core of BIOMEDRIC.
BIOMEDRIC ensures the three main stages, preclinical stage, clinical stage, and post-clinical stage, involved in the quality control of medical devices from all the manufacturers it supports, both clinically and non-clinically, are up to date. With a highly scientific and solution-oriented approach, BIOMEDRIC has debuted in 2020 shortly before the effective dates of EU MDR 2017/745 for medical devices and EU IVDR 2017/746 for in-vitro diagnostic medical devices, which are May 2021 and May 2022 respectively.
Not only this, but BIOMEDRIC also gives extensive briefings related to all aspects of medical devices, their types, usage, and the laws. The interface also promotes a user-friendly outlook to assessing the needs and use of the company, with due diligence to the regulations of EU IVDR 2017/746.