FAQs: In Vitro Diagnostic Medical Device Regulation (IVDR)
In coincidence with the EU Regulation on medical devices (MDR), the EU Regulation 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR) entered into force on 26 May 2017. The IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC).
Discover quick facts about the expected changes below.
1. What is In Vitro Diagnostic Regulation (IVDR)?
The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.
2. When is the IVDR expected to be implemented?
The IVDR was published on 5 May 2017 and entered into force on 26 May 2017. Several implementing acts to be issued by the commission are stipulated to complete some of the requirements to be met.
3. When do medical device manufacturers need to comply to the new IVDR?
Manufacturers of currently approved in vitro diagnostic medical devices will have a transition time of five years, up to 26 May 2022 to meet the requirements of the IVDR. Products already certified by a Notified Body may be placed on the market for further 2 years under some conditions, e.g. the certificate issued under the IVDD is still valid and subject to surveillance by the Notified Body who had issued it and no significant changes to the product are made.
4. What are the key changes expected in the new IVDR?
The actual terms of the proposed regulation are subject to change until final publication of the IVDR in the Official Journal of the European Union. Some of the key changes expected include:
Product scope expansion. Expanded scope will cover diagnostic (including Internet-based) services, genetic testing and other tests that provide information about a patient’s predisposition to a specific disease or susceptibility for a medical treatment.
Reclassification of devices according to risk. Risk classes will range from Class A for low risk devices to Class D for high risk devices.
More rigorous clinical evidence. Manufacturers will need to conduct clinical performance studies and provide evidence of safety and performance according to a device’s assigned risk class.
Self testing and near patient testing devices will be subject to a premarket approval approach.
More stringent documentation.
Identification of ‘person responsible for regulatory compliance’
Implementation of unique device identification for better traceability and recall
Requirements for post market surveillance will be reasonably increased and general timeline for reporting reduced.
More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices
Greater Scrutiny of Notified Bodies
No “grandfathering” provisions. All currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements.
5. What are the implications of the new IVDR for In vitro medical device manufacturers?
The complex development process for in vitro diagnostic medical devices, combined with the anticipated changes, are likely to make the transition a complicated and time consuming process for most device manufacturers. Manufacturers of in vitro diagnostic medical devices are well-advised to stay current on amendments to IVDR by Implementing and Delegated Acts, as well as additional changes that may impact them.