The new European Medical Device and IVD Regulations adopted in May 2017 replace the existing Medical Devices Directive (MDD), In Vitro Diagnostic Directive and Active Implantable Medical Devices Directive (AIMDD). The new regulatory framework will apply after a transitional period, which ends May 26th, 2020 (May 26th, 2022 for IVDs), and from that date on the new Regulations will fully apply. As many initiatives are being put in place during this period, the European Commission recently updated the MDR and IVDR implementing measures rolling plan containing the list of essential enforcing acts and actions for the transitional period as well as expected timelines and next steps for their implementation.
Although the product life-cycle regulatory approach is maintained by the new rules and supported by the European MEDDEV guidelines, these Regulations provide greater details and information from both guidance and standards than previously. Strong emphasis has been put on clinical data and clinical evaluation requirements, and equivalence between devices will be rigorously assessed, getting more difficult to demonstrate clinical safety and performance for Medical Devices and In Vitro Diagnostic products.
These new Regulations also introduce a new regulatory body called the Medical Device Coordination Group (MDCG), composed by experts representing Competent Authorities of the different EU countries, to optimize efforts and foster cooperation between Member States, which will increase the European Commission’s power to act at the same time. The MDCG will provide advice and assist the Commission and the European countries in the implementation of both Regulations. The MDCG has recently established 11 different working subgroups consisting of various stakeholders, deadline of the call for applications as observers to the MDCG working groups is November 15th, 2018.
It is important to note that as Regulations, both MDR and IVD, won’t need to be transposed into National legislation and will be implemented directly across all the Member States that participate in the EU process, which comprises 28 Member States including the United Kingdom, the European Economic Area, including Iceland, Liechtenstein and Norway and Switzerland, through bilateral treaties. However, there is no final decision on which category the United Kingdom will fall in after the conclusion of Brexit negotiations. Magellan Device Compliance Platform is abreast of the latest news in the European market, please meet us at Medica, the leading international trade fair for the medical sector (Düsseldorf, Germany from 12 – 15 November 2018), to further discuss how Magellan can keep you aware of them!