With the holidays and end of 2018 approaching, we are now past the half-way point in the 3-year implementation period for the European Union Medical Device Regulation (EU MDR). Publications and surveys have indicated that many medical device manufacturers have not finalized plans or begun the changes needed for compliance with EU MDR. Are you one of them?
Since all medical devices will need to be reassessed and registered to the new requirements and no devices will be “grandfathered”, resources including the Notified Bodies, Competent Authorities, and the European Commission may be stretched beyond their capabilities if device manufacturers wait until the last minute to schedule their assessments. Companies that have not already made significant progress in gap assessments, planning and implementation may be at risk of losing EU product registrations. At the same time, while your competitors procrastinate to implement EU MDR requirements and reregister their devices, if you make a push to implement quickly, you can create a competitive advantage with your products being first to market under the new safety and performance requirements.
Some key areas that are likely to require significant time and resources to ensure compliance are as follows (note this is not an all-inclusive list):
Changes to Notified Bodies
In light of Brexit and the requirements for Notified Bodies under EU MDR, it is important to have a conversation with your Notified Body and to understand their plans and timelines to be able to perform EU MDR assessments. It would be to your advantage to come to an agreement on implementation and assessment timelines and to perhaps even get on their schedule for assessment as soon as they are able to begin scheduling.
Medical Device Reclassification
You should immediately identify any possible changes to product risk class along with the new compliance requirements resulting from reclassification. Note the revised language throughout the regulation as “Class III and Implantable” devices, meaning that in some cases Class II devices will have the same requirements as a Class III device.
Clinical Data Requirements including Clinical Evaluation and Clinical Investigation
Some devices rely on historical data that has not been sufficiently updated and may no longer be compliant. You should review the availability, integrity and quality of all data for your devices as soon as possible. At this point it may be too late if additional clinical investigation is needed.
Technical File Updates and Documentation Requirements for all CE-Marked Products
There are now expanded requirements for the Technical Files which will require all Technical Files to be updated. In addition, the following documentation will be required for all CE-Marked products:
- Risk Management File (RMF) including a Risk Management Plan, use of appropriate risk management tools such as FMEA, etc., Risk Benefit Analysis and a Risk Management Report
- Clinical Evaluation Plan and Clinical Evaluation Report (CER)
- Post-Market Clinical Follow-up (PMCF) – PMCF Plan and PMCF Report
- Summary of Safety and Clinical Performance (SSCP) for Class III and Implantable devices
- Post-Market Surveillance Plan (PMS Plan) with linkage to the Risk Management File (RMF)
- PMS Report for Class I or Periodic Safety Update Report (PSUR) for Class IIa, Class IIb and Class III devices
- Complaint Trend Reporting including Signal Detection / Signal Evaluation
The International Medical Device Regulators Forum (IMDRF) has published UDI system guidance and MDR/IVDR UDI requirements. UDI implementation dates are based on the product risk classification, with the higher risk (Class III) devices to be implemented first. Manufacturers will need to determine where the device master data are located and who owns that data; and will need to establish the roles and UDI responsibilities for all Economic Operators (e.g. manufacturer, authorized representative, importers, distributor, assembler of systems and procedure packs) in addition to establishing the UDI systems/infrastructure, processes and labeling.
Economic Operators and Medical Device Tracking
A Medical Device Traceability/Tracking system will need to be in place. This may be more difficult for manufacturers that use multiple distributors within the EU. Manufacturers will need to understand the distribution network and document the roles and responsibilities of all economic operators. Distributors will be required to keep records of all devices they have received and from whom, as well as all devices they have supplied and to whom.
Authorized Representative (AR) Liability & Person Responsible for Regulatory Compliance (PRRC)
With greater responsibilities placed on the Authorized Representatives, companies should ensure their AR is capable and willing to meet these requirements. Persons Responsible for Regulatory Compliance (PRRC) will need to be established at the manufacturer and with the Authorized Representative.
The above are just a few examples of requirements that may take considerable time to implement. With the implementation period more than half-way through, if you have not done so already, it’s time to make EU MDR implementation a priority in order to continue to distribute product within the European Union.
It has been said, and it is true, anyone can read the regulation, but interpretation remains vague in some areas and implementation is difficult in a resource constrained environment. Improved understanding and best practices for implementation come with experience, from working with multiple companies/clients and the exchange of information throughout our network. Validant has experience in providing training and implementation tools, performing gap assessments, targeted remediation, resource assistance, as well as full turn-key solutions for implementation of EU MDR.
Contact Validant today for assistance with EU MDR implementation and to help make compliance your competitive advantage.
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