Medical device manufacturers are constantly navigating the regulatory world. And like most other industries in 2022 and beyond, that world looks to be more complex and dynamic than ever. Particularly in the EU, UK, and US, change is unfolding at an unprecedented pace and with greater stakes as governing bodies envision and adjust to the post-pandemic world. Let’s look at what manufacturers need to know right now in these three regions, and what the latest changes mean both from strategic and compliance standpoints.
European Union: Medical Device Regulatory Changes
The European Union’s (EU) Medical Device Regulation (MDR) went into full effect in May 2021 following a three-year transition period and additional one-year pandemic extension from when the regulation was first published in 2017. With Medical Device Directive (MDD) certificates all expiring in 2024, manufacturers will need to obtain MDR certification.
Under the MDR, all device manufacturers are required to have a quality system in place as well as a designated person responsible for regulatory compliance. Additionally, every device must now have a Unique Device Identification (UDI). New general safety and performance requirements have brought significant changes and additional documentation across clinical evaluation, post-market surveillance, post-market clinical follow-up, and the Periodic Safety Update Report. Clinical evaluation has seen the most transformation with it no longer being just a report, but rather, a formal plan and process with detailed guidelines and strict requirements. Across the board, manufacturers must prepare to take planning and reporting to the next level for MDR compliance.
Meanwhile, the In Vitro Diagnostic Regulation (IVDR), also released in 2017 and originally slated to take effect in May 2022, is now in a longer transition plan with the highest-risk (Class D) devices requiring a notified body review by May 2025. Class C devices have until May 2026. Class B and Class A Sterile devices have until May 2027. Class A Non-Sterile devices are under IVDR regulations as of May 2022. Currently, only 8 percent of all in vitro diagnostics (IVDs) are subject to notified body control. Under the IVDR, this number will increase to 80 percent.
The extended IVDR implementation timeline is certainly a welcomed reprieve, but manufacturers should note IVDR reviews are taking 9-11 months once an application has been accepted by a notified body. Get started now. The review period will then be a good time to revise your IVDR implementation plan, making compliance-based process updates, and obtaining your economic operator registration in EUDAMED (European Databank on Medical Devices).
Between the MDR and IVDR, there are roughly 70 new guidance documents published and roughly 30 more guidance documents pending. Europe certainly keeps us on our toes!
英国：Medical Device Regulatory Changes
Brexit further complicated the European regulatory trends in 2022 and beyond. For now, the UK is continuing with the MDD, IVDD, and Active Implantable Medical Devices Directive (AIMDD). The CE mark will remain valid in the UK until 2023年6月30日. However, the new UK Conformity Assessed (UKCA) mark became available on 2021年1月1日 and will eventually become the new standard. To obtain the UKCA mark, manufacturers will need to find a UK-approved notified body and register all devices in the UK. Additionally, a designated person responsible for UK compliance is now required.
Northern Ireland is part of the UK, but the UKCA mark presents somewhat of an exception. Because of the Belfast/Good Friday Agreement of 1998, the EU MDR and EU IVDR will apply in Northern Ireland. The important development to note in Northern Ireland is newly required registration with the Medicines and Healthcare products Regulatory Agency (MHRA). If you have a product for use in Northern Ireland, you will need an authorized representative for the EU or Northern Ireland, and you will continue to use the CE mark. Learn more about post-Brexit requirements for medical devices in the UK.
米国 (Corporate HQ)：Medical Device Regulatory Changes
In the US, the regulatory environment is fluid with new draft guidances and a recent publication released by the US Center for Devices and Radiologic Health (CDRH). Real-World Data (RWD) and Real-World Evidence (RWE) are at the center of the new US Food and Drug Administration (FDA) publication, “Framework for FDA’s Real-World Evidence Program.”
RWD are data relating to patient health status or the delivery of health care routinely collected from a variety of sources. RWE is the clinical evidence regarding the usage and potential benefits, or risks, of a medical product derived from analysis of RWD. Examples of RWD include electronic health records (EHRs), claims and billing activities, product and disease registries, patient-generated data including in-home use settings, and data gathered from other sources that can inform on health status, such as mobile devices. Under the FDA’s suggested RWE framework, RWE is more heavily scrutinized.
Other draft guidances to review include the Digital Health Technologies for Remote Data Acquisition guidance, with a close eye on what it means for a device to be “fit for purpose,” and the Transition Plans for Medical Devices (Enforcement Policies and EUAs) as society begins to transition from pandemic to endemic COVID-19. Once the latter reaches final guidance from the FDA, manufacturers of medical devices and personal protective equipment (PPE) previously approved through enforcement policies or emergency use authorizations during COVID-19 will have 180 days to submit documentation and secure approval for ongoing manufacturing. Otherwise, the time will finally come for a phase-out plan and sell-off period.
What They Say About Change Is True
In the regulatory landscape, change is the only constant. It’s happening as we speak. To learn about these regulatory changes in the EU, UK, and US along with other important updates in med tech today, watch our 2022 Medical Technology Symposium.