New regulations for medical devices were adopted by the European Parliament in April 2017 as part of an ongoing effort to clarify and modernize the previous regulations and the mechanisms which track them. These changes implemented on May 25, 2017 will come at some additional expense to medical device manufacturers – both financially and in time spent on compliance tracking.
Although the Medical Device Regulations (MDR) have been officially adopted by the EU, there are compliance time lines, both for new devices entering the market and for devices already being sold in the market with no device being grandfathered in. All devices will eventually need to be in compliance with Regulation (EU) 2017/745 and Regulation (EU) 2017/746
The changes, which were spurred on by frequent instances of misinterpretation of the old regulations, have several goals. One is to set more concise regulatory standards for tracking medical device origins and performance throughout a device’s lifecycle. The result for EU citizens will be a consistently higher level of health and safety protection under the law. Another aim of the regulations is to establish a path for EU legislation to adapt to technological and scientific progress in the medical sector while creating the ability to monitor the overall performance of medical devices across borders.
How do these changes affect medical device manufacturers selling product into the EU?
At a glance, here are just some of the more notable changes under the new MDR:
- The “Qualified Person” Requirement
Medical device manufacturers are required to identify and name at least one “qualified person” within their organization who is designated as the person responsible for all aspects of compliance and regulatory matters pertaining to medical devices manufactured at their facility.
- Establishment of a comprehensive EU database for Medical Devices
A pan-European database for medical devices (Eudamed) will be established to track devices and store relevant data throughout a device’s lifecycle. Improved transparency and traceability will be accomplished based on a UDI (unique device identification) system, which assigns each device its own tracking number.
- Labeling and Electronic Notification of ‘best practices’ for each device
Manufacturers and distributors will have to provide a label for each device which will summarize, amongst other things, its trial data information, the intended use for each device, indications and contra-indications, clinical evaluation information, and suggested profile and training of the end user. If the device is featured on a website, this information has to be made available there as well.
- Inclusion of devices previously not listed as ‘medical devices’
There are changes to the overall definition of a medical device which will expand the scope of devices that will need to comply with the new MDR.
- A new risk classification system
Because of health and safety concerns, some devices not listed as ‘high-risk’ under previous medical device regulations have now been reclassified as high risk devices. In these cases, monitoring of performance, as well as a clinical trials and data retention, will now be mandatory and impact the amount of time manufacturers spend post-market. (see Annex VIII of the MDR Classification rules)
- Stricter guidelines for performance monitoring on high-risk devices pre-market and post-market
Device manufacturers are required to perform clinical trials pre-market and will need to provide sufficient evidence to support safety and performance claims before commercialization. They are also required to collect, retain and assess on-going post-market clinical data, to determine if there are potential safety risks.
- Post-Market oversight by Notified Bodies and Independent Experts
New regulations call for increased post-market monitoring by Notified Bodies and independent experts. A ‘Notified Body’ is any entity that has been accredited by a state to assess the safety of medical devices pre-market and to determine if they are performing as stated post-market. The MDR requires all current Notified Bodies to re-apply for designation. This process, expected to be completed in 2019, will result in far fewer Notified Bodies. If a manufacturer’s Notified Body is not reauthorized, they will need to find another Notified Body to register with.
- A financial mechanism that compensates patients for defective medical devices
Another component of the tracking and reporting changes allows for the consumer to request compensation should a medical device malfunction. Previously, it was difficult for a patient from one EU country to seek damages from a manufacturer in another EU country.
Medical devices available for sale in the EU prior to the new MDR implementation in May 2017 may continue being sold under the original MDD certifications until May 2020. All medical devices will need to be compliant with the new MDR by May 26, 2020.
In-vitro devices available for sale in the EU prior to the new MDR implementation in May 2017 may continue to be sold under the original MDD certifications until May 2024. All in-vitro devices will need to be compliant with the IVDR section of the new MDR by May 26, 2024.
This is an overview and not a comprehensive, official listing of the regulatory changes for medical devices in the EU. You will find much more information regarding requirements and timelines for medical device manufacturers by reviewing the latest information on this topic from the European Commission.
The information contained in this bulletin is, to the best of our knowledge, accurate and reliable, however no guarantee of accuracy is made. Readers must conduct their own independent analysis of the information and assume all responsibility for utilization of same.
