Clinical Evaluation Center for Devices
Our Parent Concern
EU MDR 2017/745
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What is EU MDR 2017/745?
The EU Medical Device Regulation (MDR) will replace the EU's current Medical Device Directive (93/42/EEC) and the EU's Directive on active implantable medical devices (90/385/EEC). The regulation applies to all Medical Device Manufacturers who intend to place their medical devices on the European market.
On April 5, 2017, the new EU MDR 2017/745 and EU IVDR 2017/746 have been passed in the European Parliament. EU MDR stands for European Union Medical Device Regulation as indicated above and EU IVDR is the acronym of In Vitro Diagnostic Medical Devices Regulation. On May 5, 2017, the Official Journal of the European Union has published the MDR and on May 25, 2017, it came into force. The transition period will come to an end and indeed this MDR becomes mandatory from May 25, 2020. The main purpose of this MDR is to ensure that the medical devices certified under EU MDR 2017/745 are safe and efficient to use in Europe.
Why is EU MDR 2017/745 Important?
The medical devices certified under EU MDR 2017/745 are safe and efficient to use in Europe. The aim of the regulation was to ensure better facilities of patient protection, to achieve higher quality standards for Medical Devices, to promote cooperation between EU Member States (MS) and to harmonize the procedures across the EU. The MDR, in comparison to the MDD, places much greater emphasis on the requirements for supporting clinical data and closely reflects the requirements defined by MEDDEV 2.7/1 Rev. 4 with greater emphasis being placed on planning CERs and having a clearly documented process.
EU MDR 2017/745 has the following key changes when compared to MDD, thereby making it more important:
How does CECD Adhere to EU MDR 2017/745?
Seven Key Changes to Understand and Implement in MDR:
There are seven key changes to understand in MDR when compared to MDD. CECD understands and implements the below key changes in an efficient way:
Device Classification - The EU MDR brings changes to the device classification. The EU MDR also strengthens the definition of a medical device. Also, the EU MDR consolidates the conformity assessment routes from six to three methods but imposes more requirements within the routes, including a requirement to implement a fully compliant quality management system.
Quality Management System - The EU MDR requires manufacturers, distributors, and importers to implement a comprehensive quality management system (QMS). The regulation includes specific requirements related to the inclusion of a post-market surveillance system for each device as an integral part of the manufacturer’s QMS.
CE Technical Documentation - Unlike MDD, the clinical evaluation (CE) Technical Documentation required by MDR is a full set of information that demonstrates how general safety and performance are supported by design controls, manufacturing, risk assessment, post-market, etc. – it basically includes all technical information about your device.
Clinical Evaluation Requirements - The EU MDR imposes much tighter restrictions on “device equivalency” for purposes of Clinical Evaluation Reports (CER). You will want to review your CER very carefully to ensure compliance with the new requirements. There are additional requirements to report specific events to the upcoming EU medical device electronic reporting system (EUDAMED).
Identification & Traceability Requirements - The regulation contains new Unique Device Identification (UDI) requirements. The UDI requirements impose regulatory liabilities on all economic operators in the supply chain to help ensure accountability for devices provided to healthcare institutions/providers and patients. The EU regulation requires Class I devices to also provide a product identifier on the labeling. The EU regulation also expands the use of electronic systems – EUDAMED – to manage UDI information and provide more information transparency.
Postmarket Surveillance (PMS) System - The MDR regulation requires organizations to have post-market surveillance (PMS) system based on a post-market surveillance plan. Another significant change is that PMS is viewed as a proactive process that requires medical device manufacturers to be fully aware of their products in the market. Manufacturers must prepare a Periodic Safety Update Report (PSUR) for each Class IIa, Class IIb, and Class III device that is submitted to the Notified Body for review. Manufacturers will also submit vigilance and postmarket surveillance reports to EUDAMED.
Auditing Requirements - The regulation reinforces the authority and responsibilities of Notified Bodies for performing quality system conformity audits. They also strengthen the position of the Notified Bodies in their relationships with manufacturers, including their right and duty to carry out unannounced factory inspections and conduct physical or laboratory tests on devices. There is a new obligation for Notified Bodies to notify an expert committee when they receive applications for conformity assessments of high-risk devices. Also, the new Medical Device Single Audit Program (MDSAP) certification becomes mandatory for companies selling in Canada starting in early 2019, and this is exerting even more pressure on Notified Bodies as companies press to schedule MDSAP audits.
The Transition from MDD to MDR:
For clients whose medical device documents are MDD compliant, it is high time to start working on the transitions from MDD to MDR. When compared to MDD, the MDR has more rigorous requirements and assessment procedures. During the transition from MDD to MDR, we review and revise the documents prepared for MDD earlier in order to meet regulations of EU MDR 2017/745. We take care of the following updates:
We reassess the CERs considering limitations on equivalent devices, state of the art and updated to withstand a higher level of scrutiny from the Notified Body level and above. Updates to CERs may also trigger updates to Instructions for Use; we make sure they are in alignment.
We conduct clinical investigations within the constructs of the new legislation (EU MDR Annex XV) and recognized ethical principles. They must also align with the clinical evaluation plan.
Post-market clinical follow-up (PMCF) will no longer be a “check-the-box” activity. As a matter of fact, Annex XIV Part B of the EU MDR is dedicated to PMCF. Notified Bodies will be looking for “living” PMCF plans and reports.
We will update the summary of safety and clinical performance “at least” annually and ensure that a more frequent assessment is done.
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