Considerations for a harmonised approach for handling changes arising from the transition to EU MDR and IVDR
In 2017, the European Union adopted Regulations (EU) 2017/745 (EU MDR) and (EU) 2017/746 (EU IVDR) with the aim of creating a robust, transparent and sustainable regulatory framework for medical devices and in vitro diagnostic (IVD) medical devices that is recognised internationally. The EU MDR replaced the Medical Devices Directive 93/42/EEC (EU MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and became applicable on 26 May 2021. The EU IVDR replaced the IVD Medical Devices Directive 98/79/EC (EU IVDD) and became applicable on 26 May 2022.
The EU MDR and EU IVDR introduced major updates to the European regulatory framework effectively leading to more information being available about medical devices. This modernisation introduced several changes to the regulatory documentation required to place medical devices and IVDs on the European Union (EU) market. The impact of the transition to the EU MDR and IVDR extends well beyond Europe as CE marking, recognised as evidence of compliance with EU legal requirements, is widely used to support medical device and IVD registrations in international markets. The extent of the impact varies across jurisdictions depending on their specific regulatory requirements. It is also important to note that not all changes apply to all medical devices and IVDs in the same way. Therefore, changes to regulatory documentation because of the EU MDR/IVDR are likely to vary from device to device.
The transition to EU MDR and EU IVDR, their subsequent respective amendments (Regulation EU 2023/607, Regulation EU 2022/112 and Regulation EU 2024/1860), as well as the complexity of the requirements under the Regulations, have proven challenging to navigate also to non-EU regulators.