IVDR upcoming Changes, get ready !!
In vitro diagnostic medical device manufacturers will soon be expected to comply with major changes in the European Union’s (EU) long-standing regulatory framework which governs market access to the EU.
The IVDR was officially published on 5 May 2017 and entered into force on 26 May 2017. Manufacturers of currently approved medical devices will have a transition time of five years until 26 May 2022 to meet the requirements of the IVDR. Under certain conditions, products already certified by a Notified Body might be placed on the market for additional 2 years. It is important to note that, as an EU regulation, the IVDR will have the force of law throughout the EU when it comes into effect. This approach should eliminate country by country interpretations of the requirements permitted under current directives.
The proposed IVDR differs in several important ways from the EU’s current directive on in vitro diagnostic medical devices. Most significant changes in the proposed regulation include:
- Product scope expansion - The scope of IVD devices covered under the regulation will be significantly expanded to include high-risk devices manufactured for use within a single healthcare institution, as well as diagnostic (including internet based) services, genetic testing and other test that provide information about a patient’s predisposition for a specific disease or for susceptibility for a medical treatment.
- Re-classification of devices - The IVDR will impose a classification structure for in vitro devices consistent with that of the Global Harmonization Task Force (GHTF). Risk classes will range from Class A for low risk devices to Class D for those devices that pose the greatest risk to patients and the public. The Regulation provides specific rules for properly classifying IVD devices according to their level of risk instead of lists.
- Identification of 'a person responsible for regulatory compliance' - Device manufacturers will be required to identify at least one person within their organization who is ultimately responsible for all aspects of compliance with the requirements of the new Regulation. The organisation must document the specific qualifications of this individual relative to the required tasks.
- Increased Notified Body involvement - The application of the IVDR’s risk classification scheme will likely require the involvement of a Notified Body for the approval of all but Class A devices. As a result, it is expected that more than 70 percent of all IVD devices will now be subject to Notified Body review, compared with less than 15 percent currently. Concurrently, the requirements for designation and monitoring of Notified Bodies under IVDR will be considerably tightened.
- Implementation of unique device identification - The proposed regulation mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of IVD devices that have been found to present a safety risk.
- More stringent requirements regarding technical documentation and clinical evidence - The level of detail regarding the contents of the technical documentation will be reasonably increased. The IVDR will require device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with a device’s assigned risk class. Device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
- No "grandfathering" provisions – Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. Manufacturers with currently approved devices will have five years to demonstrate