With the new EU MDR, all medical companies need to ensure that they meet the new regulation to sell the medical devices in the European Union.
What is EU IVDR?
The IVDR regulation is applied to medical devices that medical companies use to diagnose medical issues.
IVDR is the replacement of IVDD (In Vitro Diagnosis Directive). IVDR is applied especially on medical devices that will be manufactured and sold in the European Union.
Since May 2017, the new EU IVDR regulation is more demanding due to a lot of changes in In Vitro Medical industry. According to the new IVDR, more companies have to register with a notified body instead of self-certifying. Every medical company needs to ensure that their technical documentation meets all the new requirements in the first step only.
What is New MDR?
The European Union Medical Device Regulation also called EU MDR is the new legal requirement that applies to medical devices that will be manufactured in or supplied within European Union.
This regulation is the new version of the previous MDD regulation which was in the European Union for almost 25 years. The New MDR applies to medical devices to ensure that medical devices are of high standards and with a safety kit before they will be manufactured or supplied within the European Union.
The New MDR will come into effect from May 2021 and all medical devices must be certified according to the new guidelines by May 2024, or before if the MDD certificate expires before this date.
Difference Between MDR and IVDR
The EU MDR and IVDR were originally published on May 05, 2017, by the parliament. They said this is an important requirement for the medical devices and IVDR manufacturers that distribute the products in the EU.
The CAMD – Competent Authorities for Medical Devices Executive Group recommended the establishment of an IVDR/MDR implementation execution team to work with collaboration and joint effort within the organization of the medical devices during the performance stage of the new regulations.
The main objective of In Vitro Device Regulation and Medical Device Regulation is to implement an effective, predictable, robust, and secure regulatory system with better protection for human health in the medical device sector.
The new MDR is somehow different from the IVDR regulation. The new MDR does not include any guidelines for IVDR medical devices as they leave this to be covered by IVDR regulation only.
However, in Article 1(pint 7), the new MDR covers that how two regulations are related. This is only possible when both the regulations use the same medical devices.
The EU MSR and IVDR are different regulations with different rules and different substance lists that are applied to different devices. These two different regulations are the two sides of the same coin.
Below we have collected some comparison points between MDR and IVDR
MDR applies to medical devices that come into direct contact with humans that will be manufactured or sell into the EU.
IVDR applies to In Vitro medical devices covering diagnostic and monitoring devices that will be manufactured or sell into the EU.
UDI – Unique Device Identification
The purpose of unique device identification is to identify or track the devices that will be supplied within the European Union.
A unique device identification number is required in both MDR and IVDR.
MDR requires a clinical evaluation report based on the evaluation of clinical evidence which becomes part of the Clinical Evaluation technical report.
IVDR requires performance analysis and performance studies for IVD devices which later becomes part of the Clinical Evaluation technical report.
MDR requires ongoing post-market clinical follow-up.
IVDR requires post-market surveillance and vigilance.
To learn which documents are important in PMS template MDR, visit our website to check out in-depth.
In MDR notified bodies to apply to all classes on medical devices.
In IVDR notified bodies are applicable more in Vitro Diagnosis devices only.
The most important thing to note about MDR and IVDR is that soon these regulations are coming into effect. All manufacturers of medical devices have to ensure their future compliance before they come into effect.