IVDR

In 2017 the European Commission changed and updated the legal framework regarding the medical devices, superseding the existing directives, with two new regulations which added new responsibilities for European Medicines Agency and national regulatory authorities. The two new regulations, the MDR 2017/745 on medical devices and IVDR 2017/746 on in vitro diagnostic devices are scheduled to be fully implemented (after a transition period) from may 26-th 2020 (MDR) and may 26-th 2022 (IVDR), respectively. During this transition period the existing EU directives (93/42/EEC, 98/79/EC and 90/385/EEC) will apply to any medical device tested to be put on the market but the manufacturers can opt to follow the new regulations under the condition of full compliance with them. The new directives demand a mandatory conformity assessment for all devices manufactured in the EU, to prove that they conform to the legal requirements, perform as claimed and are safe to use. Only after passing a conformity assessment the manufacturers can put a CE mark (Conformité Européenne) on their medical device. These conformity assessments will be conducted by accredited bodies, designated by EU member states. The procedure for obtaining the CE mark requires an audit of the manufacturer's technological workflow and an evaluation of the technical and scientific documentation supporting the performance and safety claims of the device. In the new legislation, the Clinical Research Organizations (CRO) are assigned a more important role in providing the scientific evidence and regulatory assistance during the whole process of placing a medical device on the market. The new MDR and IVDR directives emphasize a more robust clinical evaluation process to collect and analyze data pertaining to a medical device. They also require clinical evaluations to assess whether there are sufficient data to prove the compliance of the device with the requirements for safety and performance, when...
The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the three-year transition for the EU Medical Devices Regulation), the procedures to designate Notified Bodies (NBs) under each of these two regulations have started at the same time. NBs are already submitting their applications to Designating Authorities to be ready for the new IVDR. Nevertheless, the new designation process brings up some unique issues for both manufacturers and NBs. When compared to the IVD Directive, the IVD Regulation represents a revolutionary change for both NBs and manufacturers. Under the existing Directive, approximately 10-20% of IVDs have been through the certification process involving NBs; this will increase to more than 90% under the new Regulation. Those who have read the Commission Implementing Regulation EU 2017/2185 (23 November 2017), will have seen how it defined the new scope designation codes [1] representing IVD, and the related scientific/technical competences that NBs must demonstrate to the Designating Authorities. There are now over 80 codes (under the IVDD, there were just 27 NBOG codes), adding a whole new level of complexity. Although the Implementing Regulation was subject to a public consultation and received a number of proposals for amendments , it was, in my view, published without substantial changes (See MedTech Europe’s comments as well as at the amendments proposed by others). Given the wider array of IVDs that will require certification, I believe that the NBs’ goal may be to enlarge the range of product certification that they can offer and to prepare for a significant increase in quantity and quality of work. In order to demonstrate their own expertise to Designating Authorities, NBs will need to determine how many product codes will be covered by their expert teams...

Stefano Dettori

IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)