What is IVD/IVDR

In Vitro Diagnostic (IVD) medical devices are intended for examining specimens of the human body to either provide information on the physiological state of the patient or to monitor therapeutic measures. They could also be used to define the compatibility of products with the patient’s body.  IVD medical devices are represented by calibrators, specimen receptacles, control materials, and reagents. This group includes various pathology test and similar instruments intended for examination of samples of human origin. They could be used either separately or in combination with other medical devices and products, both in healthcare institutions and laboratories, or at home by patients themselves. The most common IVD medical devices are Human Immunodeficiency Virus (HIV) and hepatitis C virus (HCV) tests. The main feature of IVD medical devices is that they are intended for in vitro use by the manufacturer. There is a specific sub-group called in-house IVD that includes devices created within the particular healthcare institution and thus not intended for third party use.  At the same time, some of the devices intended for similar purposes are excluded from regulation. In particular, these are devices that are not intended for therapeutic use, such as alcohol or parentage tests. According to the Regulation described below, all genetic tests and other tests providing information to predict treatment response are in vitro medical devices too. 

IVDR, or Regulation (EU) 2017/746 of the European Parliament and of the Council is a legal act intended to establish regulatory framework in the sphere of in vitro diagnostic medical devices. It replaces the Directive 97/79/EC and other documents regulating the related sphere. The main goal of the new IVDR is to improve transparency and maintain a high level of safety for public health, establishing a balance between protecting health, and the interests of small and medium enterprises involved in medical device manufacturing. The Regulation also establishes standards applicable for these types of medical devices and general requirements for their safety and efficiency.  

How It Works

IVDR regulates all issues related to assessment, registration, distribution, and post-market maintenance related to medical devices. The list of main innovations implemented by the regulation includes the following: 

  • Each company shall designate a person responsible for regulatory compliance. This position employs the same principle as Data Protection Officer in GDPR. The responsible person would manage all issues related to compliance with applicable regulations and rules, and maintain communication with regulatory authorities. This person should have relevant qualifications and experience necessary to perform these functions.
  • The list of medical devices falling within the scope of regulation was expanded substantially. Now it also includes software as medical devices as well as online services used for self-diagnostic purposes. According to the Regulation, software is an IVD medical device if it is intended for appropriate purposes by the manufacturer. The distinction between software and other devices does not matter. 
  • Even if the particular IVD medical device has been approved earlier and now has a valid certificate allowing its manufacturer to distribute it, the device should also pass obligatory certification under the new rules. 
  • Each medical product should have a unique identification code that allows any person to check the origin of the device and information about the manufacturer and the device itself. 
  • New classification rules would be applied to in vitro medical devices based on the potential risk to patients. This classification includes safety classes from Class A to Class D, depending on the risks associated with the particular device. The devices of all classes (except Class A) are subject to pre-market approval by notified bodies. Classification rules developed regarding the specific features of IVD medical devices, distinguishing them from other medical devices. 
  • Regulation includes requirements for safety and performance of medical devices and also the requirements applicable to the manufacturing process to ensure the safety at all production stages. Each medical device manufacturer should implement the appropriate quality management system. 
  • Medical device manufacturers obliged to evaluate the performance of medical devices and vigilance reporting, providing information on all adverse events and incidents occurred during the use of medical devices.

The Importance of IVDR

IVDR has been effective since May 26, 2017. It is applicable within the territory of the European Union, so any medical device manufacturer that is going to distribute its products in the European market should comply with the appropriate regulations. There is a special transition period provided for medical devices that are already present in the market – it is five years, up to May 26, 2022. 

According to the new rules, medical device manufacturers should not file the approval to the national regulating authority in the sphere of healthcare nor to its department responsible for medical devices, but to notified bodies, which are special institutions designated to review marketing submissions, perform conformity assessments, examine the documents, evaluate safety and efficiency to be able to approve or refuse the particular device. Notified bodies also have the power to conduct trials and examinations of samples provided by medical device manufacturers. There are very few notified bodies designated within the EU, which could probably cause some issues and difficulties with marketing approval if they fail to deal with the growing amount of submissions. That is why IVD medical device manufacturers should be aware of possible delays during the certification process. 

If a medical device manufacturer is not established in the EU, it is necessary to appoint an authorized representative to perform all procedures related to compliance and deal with regulatory issues. Authorized representatives shall communicate with notification bodies and perform post-market maintenance and surveillance. 

How RegDesk Can Help

RegDesk’s platform provides in vitro diagnostic medical device manufacturers with the latest updates on the most important regulations applicable to this type of device. The regulatory framework incurs substantial changes nowadays, so it is necessary for each involved party to be aware of the most recent amendments and requirements implemented to maintain compliance and to be able to distribute medical devices in the European market. RegDesk provides well-structured and reliable information on IVD medical device regulations to help medical device manufacturers deal with regulatory issues. 

Other interesting article about IVD regulations: https://www.regdesk.co/medtech-mdr-ivdr/