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How RQM+ Supports You
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Compliance Strategies That Go Beyond Risk-Based Necessity
EU MDR has forced manufacturers to rethink their current regulatory practices, internal methodologies, and ongoing level of compliance investment. Our transformative solutions were developed specifically to navigate the intricacies of today’s regulatory environment, including the necessary shift in compliance strategies from risk-based necessity to value-driven solution.
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Business-Balanced Solutions from a Strategic Partner
We know how challenging it is to give equal attention to every product in your portfolio, especially when internal resources are strained. From portfolio planning to project management to executing discrete regulatory tasks, RQM+ helps you develop and implement risk-balanced strategies that are tailored to your business goals.
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Unrivaled Collective Knowledge and Industry Connections
One of our greatest advantages is our ability to recruit former notified body leadership, including experts who have participated in committees and contributed to the content of standards and guidance documents. With this knowledge base—plus our deep commitment to ongoing learning through systemized processes—we bring a level of expertise that other consultants cannot match.
2017
Entry Into Force
The EU MDR was published in the Official Journal of the European Union on 5 May 2017, and entered into force on 26 May 2017.
26 MAY 2017
Entry into Force
The EU MDR was published in the Official Journal of the European Union on 5 May 2017, and entered into force on 26 May 2017.
2021
Date of Application
All medical devices and related procedures, systems, and documentation in the EU must comply with the new MDR by this date in order to enter the market.
26 MAY 2021
Date of Application
All medical devices and related procedures, systems, and documentation in the EU must comply with the new MDR by this date in order to enter the market. Certificates issued under the MDD before this date may remain valid for up to three additional years.
If you make a significant change to your MDD certified device, you will be required to obtain MDR certification.
All devices, whether MDD or MDR certified, must have EU MDR PMS, Vigilance, and Market Surveillance on the date of application. Registration via ACTOR module of EUDAMED strongly encouraged.
2022
EUDAMED and PSURs
EUDAMED is scheduled to be launched starting a 24 month clock to enter data.
26 MAY 2022
EUDAMED and PSURs
EUDAMED is scheduled to be launched starting a 24 month clock to enter data.
PSURs are required for all class IIb and III devices (unless PMS plan has an earlier date).
2023
PSURs for Class IIa
PSURs are required for all Class IIa devices unless the PMS plan has an earlier date.
26 MAY 2023
PSURs for Class IIa
PSURs are required for all Class IIa devices unless the PMS plan has an earlier date.
2024
Last Market Date
Any unexpired notified body certificates issued under MDD will become void on this date. All devices placed on the market must conform to EU MDR.
26 MAY 2024
Last Market Date
Any unexpired notified body certificates issued under MDD will become void on this date. All devices placed on the market must conform to EU MDR.
Sell-through provision starts for MDD devices already on the market. Class I devices that require a notified body must be compliant with EU MDR.
2025
Last Service Date
This is the last possible date for putting MDD devices into service that were already on the market.
26 MAY 2025
Last Service Date
This is the last possible date for putting MDD devices into service that were already on the market.
NAVIGATE AND FILTER
THE IVDR AND MDR
Our new series of interactive tools allow you to easily filter lines of the IVDR and MDR by topic, chapter, section, article, and any search term. Many of our experts have this tool open at all times on their computers for quick access and it's been a game changer. Now we're sharing them with you!
Tiger Team Approach
We will provide a team that has a single focus on MDR implementation and continual alignment with your business. RQM+ ensures project goals and deadlines are met with steering teams, stage gate reviews, and workstream owners so that every aspect of MDR is covered. This approach allows your team to focus on current activities while maintaining alignment and control of EU MDR implementation.
Regulatory
We provide a customized strategy by product line and portfolio planning support that balances regulatory risks with business goals. This includes gap analyses by product family; product realignment in MDR technical documentation files; and gap closure with product development, manufacturing, post-market surveillance, and clinical teams. We also provide strategy and responses to notified body audit findings, including negotiation, based on recommendations from former notified body leaders and SMEs on staff.
Risk
Design quality engineers provide gap analyses of design history files and full remediation or SME guidance to client teams as needed to achieve compliance. RQM+ can offer support across all impacted areas, including risk management, standards compliance, supplier quality, clinical evaluations, biocompatibility, hazardous substances, labeling, and manufacturing. We also provide strategies for demonstrating compliance of legacy products to updated standards including rationales and justifications where possible.
QMS
When you need to prepare your quality management system (QMS) for the transition to MDR, our expert team can develop the quality plan and help you implement it. We provide comprehensive QMS gap assessments, quality system leadership, and implementation of QMS updates for MDR compliance. Certified biomedical auditors perform internal and mock NB audits and supplier and economic operator audits to ensure compliance.
PMS
MDR requirements have significantly increased post-market surveillance (PMS) deliverables, and many manufacturers are struggling to allocate the necessary resources. RQM+ has extensive thought leadership and expertise in creating PMS and PMCF plans and periodic safety update reports (PSURs) along with developing and executing retrospective PMCF studies. Our integrated approach ensures consistency between PMS, CERs, and risk management documentation.
Featured Leader
Amie Smirthwaite, Ph.D.
Senior VP, Intelligence & Innovation
Dr. Amie Smirthwaite joined RQM+ in March of 2020. A clinical and regulatory affairs expert, Amie has over 25 years of postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems, and clinical data evaluation. She is leading the RQM+ Intelligence and Innovation team and brings a wealth of knowledge and experience having worked for medical device companies, academic institutions, and BSI.Outsourcing can feel like you are losing control over important support functions with increasing reliance on a third party—but not with RQM+. We act as a strategic partner that integrates fully with your team and adds value to your business through transformative solutions.
MDR Implementation Video FAQs
Relative to biological equivalence requirements, what are the differences from MDD to MDR?
Compared to the MDD, the MDR does require more substantial evidence when a product is equivalent which manufacturers are finding a bit harder to achieve. The MDR requires technical, biological, and clinical characteristics that are shared equivalence to another device that you’ll want to consider.
There are 3 rounds of questions, but if the NB brings in a new expert during the review (clinical, for example), will that additional reviewer have his/her own 3 rounds of questions?
Compared to the MDD, the MDR does require more substantial evidence when a product is equivalent which manufacturers are finding a bit harder to achieve. The MDR requires technical, biological, and clinical characteristics that are shared equivalence to another device that you’ll want to consider.
What are the timelines looking like for an MDR review?
Although it is difficult to give a specific timeline, BSI is doing three rounds of questions and your response to the questions will play into the timeline of the overall review. We have heard as little as six months, however, we have experienced much closer to 12 months.
Tap into the RQM+ Knowledge Center
Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 2!
PMCF Under MDR Whitepaper
What if I'm not ready for EU MDR on May 26, 2021?
Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions (Devices & IVDs)
How to Obtain CE Marking Under the MDR
Can we use PMCF to fill current clinical evidence gaps?
We are passionate about your success. Tell us more about your needs so we can help.
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