After five years of drafting, the new Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR) were adopted on April 5, 2017 and became effective on May 25, 2017. These regulations will impact all medical devices, including active implantables, “general” medical devices, in vitro diagnostics (IVD), drug delivery devices and companion diagnostics, along with a new group of “devices without a medical purpose” (such as cosmetic fillers).
However, the new rules will only apply fully after a transitional period. This period lasts for three years after the entry of the regulation on medical devices (until May 2020), and five years after the adoption of the regulation on in vitro diagnostic medical devices (until May 2022). After May 26, 2020, all medical devices will need to include a unique device identification (UDI) code. Devices which fall under Class III and Class IIa/b will have their UDI recorded, indexed, and registered on a central European Union (EU) database called EUDAMED – the European Database on Medical Devices.
Manufacturers of Class III and Class IIa/b products will be responsible for sharing product data according to Annex VI Part B of the new regulation. Manufacturers of Class I products will also be required to collect and save product data, but only share this information if requested.
There is no “grandfathering” of products from the current Directives to the new Regulations, thus the new regulations will impact every device manufacturer bringing new devices to the EU market.
Reasons Behind Changes
Problems with diverging interpretations of the current Directive, along with the incident concerning the fraudulent production of the Poly Implant Prothese (PIP) silicone breast implants, highlighted the weaknesses of the legal system in place at the time. This significantly damaged the confidence of patients, consumers and healthcare professionals regarding the safety of medical devices. The new regulations aim to ensure the following: a consistently high level of health and safety protection for EU citizens using medical device products, the free and fair trade of the devices throughout the EU, and the recognition of the technological and scientific developments in the medical device arena which occurred over the last 20 years.
What Is New
The major principles of the European regulatory system have not changed, specifically the CE marking classification rules based on risk (newly introduced to the IVDR), conformity assessment for most devices using third party Notified Bodies, and manufacturer self-certification for the lowest classes (Class I MDR and Class A IVDR).
Nevertheless, the new key additions to the Medical Devices Regulation (MDR) are significant. The MDR introduces an additional pre-market scrutiny stage for Class III and implantable devices, whereby the Notified Body must consult a new Commission Expert Panel in the conformity assessment process. For all devices, a renewed focus on clinical evaluation and clinical data will require manufacturers to focus on this area early on to ensure they have sufficient data available. New restrictions on equivalence will mean that, for higher risk devices, reliance on clinical data from an equivalent device will be possible only if there is full access to technical documentation of the equivalent device. Manufacturers will also need to ensure that they have robust post-market clinical follow-up plans in place. For Class III and implantable devices, manufacturers are now required to produce a summary of safety and clinical performance to be evaluated by the Notified Body before being uploaded to the EUDAMED data base.
There are higher burdens for IVD manufacturers as well. Approximately 80-90% of all IVD’s will need some level of Notified Body intervention, compared to only around 10-20% under the former Directive. Also, for companion diagnostics, a large number of assays that were self-declared under the IVD Directive are moved to Class C under the IVD Regulation, requiring Notified Body assessment for the first time. New clinical evidence requirements for IVD’s will be necessary to ensure that an acceptable level of evidence is available.
Persons Responsible for Regulatory Compliance and Vigilance
Both the manufacturer and the Authorized Representative must appoint a person for their own entity with formal qualification of two years’ experience, or five years’ experience if no formal qualification, in a Quality Assurance/Regulatory Affairs role. Responsibilities include batch release, maintaining Technical Documentation and vigilance overview. Most of the current medical device guidance on vigilance is incorporated into the regulations and is compulsory. However, current 30-day reporting is reduced to 15 days, and there is a central portal for reporting with increased focus on trend reporting.
The introduction of the EU MDR obligates medical device manufacturers to invest in additional technology to enable the fast and accurate application of traceability coding to products and packaging at the individual item level. Failure to comply may result in withdrawal of products from sale. A new prescribed format of technical documentation with additional detail required to ensure presentation in a clear, organized, readily searchable way is a crucial change. The essential requirements are being replaced with “safety and performance requirements” which will necessitate technical files to be re-written. All of the new changes might also affect registrations outside the US which rely on CE marking. Even though transitional grace periods are in place, due to the complexity and level of effort required, manufacturers should begin immediately to work to ensure compliance before May 2020 for medical devices and 2022 for in vitro diagnostic devices.
Ensuring Your Organization Is Prepared
The new EU regulations for medical devices and in vitro diagnostic medical devices pose new regulatory hurdles and require significant changes. As May 2020 approaches, consider having an independent assessment to determine your organizational readiness to ensure compliance with the new regulations.
About the Author: Judith (Judy) Meritz is a seasoned regulatory counsel to senior management and senior executives in the medical device industry. Judy specializes in strategic planning and compliance remediation concerning Food and Drug Administration (FDA) and other international regulatory authority matters, including due diligence for acquisitions, governmental enforcement resolution, product approval strategies and global marketing and advertising program compliance.