Transitioning to the EU In Vitro Diagnostic Devices Regulation


The application date of May 26, 2022 for the EU In Vitro Diagnostic Medical Devices Regulation (2017/746), commonly referred to as IVDR, has come and gone.  IVDR has created challenges for in vitro diagnostic (IVD) medical device firms planning to introduce or continue to market their products to the European Union.


IVD Device Classifications


One of the biggest changes from the in vitro diagnostic directives (IVDD) to IVDR is the move from list-based IVD device classifications to a rule-based IVD medical device classification. The new classification results in four new device classes: class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body (NB) involvement.


This change requires a large number of NBs, and the increased workload is cause for concern. Moreover, it is estimated that the quantity of medical device products will increase from 20% under the Medical Devices Directive (MDD) to approximately 80% under IVDR. As of this writing, there are only four IVDR designated NBs, which highlights the shortage.


IVD Scheduling Delays


Proactive strategic planning and effective resource allocation are critical for the timely execution and implementation of a comprehensive IVDR implementation plan. IVDR manufacturers must consider and prepare for potential delays. Scheduling bottlenecks for NB conformity assessment activities can impact planned commercialization efforts for existing and/or new IVDR products. It is necessary for IVDR manufacturers to establish contingency plans to mitigate these potential challenges.


regulatory compliance

Additional nuances from IVDD to IVDR are based on a medical device life cycle approach and include:


  • Requirements for medical device manufacturers to establish and demonstrate effective quality management systems (QMS).
  • More stringent requirements for clinical evidence demonstrating conformity.
  • New requirements for postmarket performance monitoring and reporting.
  • Greater supply chain oversight and device traceability, including giving NBs discretionary authority to monitor supplier audits and subcontractor compliance.


IVD Timing


The move from IVDD to IVDR can be a time-consuming process, and many medical device companies are still in the process of making the transition.


Timing is an issue because companies need to:


  • Evaluate if their current NB is still the right partner to work with.
  • Plan the regulatory strategy of the current medical device in the field.
  • Know the IVDD certificate expiration date and prioritize the products that need immediate attention.
  • Classify devices according to the new IVDR classification rules.


No matter the size of your company, if you have not already started your transition, you will need to start preparing for the IVDR deadline now as it is quickly approaching. Timely compliance to IVDR requires a dedicated team of subject matter experts.


For example, the goal is to properly implement and execute the deliverables as laid out in your IVDR implementation plan. These deliverables may require extensive updates to a manufacturer’s existing QMS and technical documentation. Likewise, establishing or enhancing a manufacturer’s body of objective evidence of clinical performance is validation for the product lifecycle.


Having the Proper Team of IVD Experts


Organizations have a better chance of a successful transition by having a team of subject matter experts with intimate familiarity of the implementation of IVDR.


The subject matter experts should identify the intended purpose and inherent risks associated with your device(s). This will determine the device classification and help create technical documentation in compliance with IVDR.


Robust procedures for postmarket surveillance and postmarket performance follow-up must be put in place to successfully transition to IVDR.




If you are planning to introduce or continue to market your IVD products to any of the EU member states you must identify the new classifications your devices fall under. This includes anticipating potential scheduling delays caused by the limited number of NBs capable of reviewing IVD device classifications. Above all, plan carefully for the entire process. Putting together the right team to handle the work can ease the transition.


About RCA’s Medical Device Services



The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.


Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such




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With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.


Regulatory Affairs


Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.


As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 


  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR


Compliance Assurance


Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.


Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.


  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response


Quality Assurance


Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.


In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.


With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.


  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • Facility Validation
  • Equipment Validation


Remediation Support


Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.


Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.


  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 


Strategic Consulting


Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® Inc.’s worldwide experience can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.


Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.


  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information


About RCA


Regulatory Compliance Associates® (RCA) provides regulatory compliance consulting to the following industries for resolution of compliance and regulatory challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.



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