The medical device industry is facing unprecedented regulatory, cost, and resource pressures with the implementation of EU MDR. We know how complex regulatory compliance has become. With our transformative regulatory and quality solutions, we not only help you obtain and maintain MDR certification but also add value to your business.

How RQM+ Supports You

  • 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.

  • 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.

  • 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. 

    Learn more about our Unrivaled Collective Knowledge

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    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. 

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    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.

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    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).

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    26 May 2023

    PSURs for Class IIa

    PSURs are required for all Class IIa devices unless the PMS plan has an earlier date.

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    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.

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    26 May 2025

    Last Service Date

    This is the last possible date for putting MDD devices into service that were already on the market.

  • 26 May 2017
  • 26 May 2021
  • 26 May 2022
  • 26 May 2023
  • 26 May 2024
  • 26 May 2025

If MDR implementation has your team struggling, RQM+ is here to help.

Deadlines are approaching fast, and even the most organized regulatory teams are finding it challenging to meet the needs across all product lines. We have the expertise and experience you need, including targeted support in key areas and comprehensive strategic solutions and implementation.

spreadsheet

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!
 

Explore IVDR ToolExplore MDR Tool

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 user surveys. Our integrated approach ensures consistency between PMS, CERs, and risk management documentation.


We do more than add capacity to your team. We add value to your business. When you need a strategic partner to support MDR implementation, RQM+ has it all: experience, expertise, thought leadership, and unique industry insights.

01 Expert Implementation

Your internal team might be new to MDR, but our project managers and SMEs have implemented the current regulations from start to finish.  

02 Best Practices and Case Studies

Our interactions and feedback from multiple notified bodies—including BSI, TÜV SÜD, and GMED—have allowed us to develop best practices for every type of product. 

03 Client-Validated Processes

We have created hundreds of technical documentation files for 70+ clients across all device classes, and we refine and improve our processes with every submission.   

04 Former Notified Body Leadership

Our team members have participated on committees, drafted MDCG guidance documents, created MDR interpretations, and trained notified body teams. We understand notified body expectations. 


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.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

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