Antonella Kotefski | Senior Regulatory Consultant
Antonella has over 20 years of regulatory experience and has successfully completed hundreds of device registrations in key markets including USA, Europe, Australia, Canada, Middle East and Asia. She has worked in regulatory affairs for organisations ranging from start-ups to multi-nationals with revenues over $1 billion, on all classes of devices.
Antonella’s strategic regulatory roles have included global product strategy, input into R&D, marketing, manufacturing, sales and device technical file/history file report writing, post-market activities, reporting to regulatory authorities, QMS and MSDAP quality systems certification.
Antonella has responsibility for leading the regulatory strategy team at Hydrix.
Medical device regulations worldwide are evolving to adapt to technology advancements, address emerging risks, enhance patient safety, and improve the regulatory framework. The European Union (EU) stands out with significant changes in its Medical Devices Regulations 2017/745 (MDR) and In Vitro Diagnostic Regulations 2017/746 (IVDR). These changes add complexity to device development, manufacturing, and certification processes. They broaden the scope of regulated products, update technical file documentation requirements, demand stricter clinical evidence, and impose more stringent criteria for clinical trials. All these adjustments are aimed at meeting EU MDR and IVDR conformity assessment requirements for Notified Body assessment and CE certification.
A well-defined regulatory strategy is crucial to ensuring compliance and demonstrating conformity with these regulations. This strategy maps out the requirements for devices under development or review, helping to plan and implement regulatory activities effectively. Key steps include defining the device’s scope and intended use, specifying verification, validation, clinical, and technical documentation requirements, which are subject to assessment by the regulator. Such a strategy is essential for navigating the complex regulatory landscape, avoiding costly delays and ensuring market approval.
Many device manufacturers rely on European conformity assessment evidence to expedite approvals globally. European CE certification is widely recognized, streamlining approvals in numerous countries. Investing in updating device technical files and quality requirements to meet EU MDR and IVDR standards offers broad benefits beyond the EU market. Moreover, global harmonization of medical device regulations is in progress, with many countries aligning with EU MDR and IVDR principles and considering their adoption, reinforcing the importance of compliance with these regulations.
European MDR and IVDR Rollout: Challenges and Solutions
Since the introduction of the MDR and IVDR, all Notified Bodies previously certified under the Medical Devices Directive 93/42/EEC (MDD), Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), and In Vitro Diagnostics Directive 98/79/EC (IVDD) had to undergo recertification to align with the new regulations. Due to the substantial investment required for this transition, many Notified Bodies chose to discontinue certifying medical devices and IVDs. As of September 2023, only 39 Notified Bodies have received EU MDR certification, and 11 have obtained EU IVDR designation, as per the European Commission Single Market Compliance Space website.
The reduction in Notified Bodies available for certification, coupled with the increased regulatory demands and expanded technical file documentation requirements, has led to significant delays in both the recertification of existing devices and the certification of new devices under MDR/IVDR.
Compounding these certification delays, approximately 80% of IVDs that previously relied on self-certification under IVDD now necessitate a Notified Body conformity assessment for CE certification of their technical files in compliance with the European IVDR. Consequently, deadlines for legacy device certification under MDR and IVDR, initially set for 26 May 2021 and 26 May 2022, respectively, have been extended to accommodate these challenges.
MDR transitional dates
On 15 March 2023, the MDR transition period for legacy devices with current European MDD certification was extended from 26 May 2024 to:
- 26 May 2026 for Class III implantable custom-made devices
- 31 December 2027 for Class III and implantable Class IIb devices
- 31 December 2028 for Class I devices that are classified higher according to the MDR
- 31 December 2028 for non-implantable Class IIb and lower risk devices
New devices must comply with the MDR from 26 May 2021.
IVDR transitional dates
For IVDs, since the IVDR date of application of 26 May 2022, there is an extended transition period from the IVDD to IVDR for legacy devices, until:
- 26 May 2022 for self-declared class A non-sterile devices
- 26 May 2025 for Class D devices
- 26 May 2026 for Class C devices
- 26 May 2027 for Class B devices
- 26 May 2027 for Class A sterile devices
Additional Requirements of the European MDR and IVDR
The MDR and IVDR usher in a more robust and transparent regulatory framework designed to enhance clinical safety. Manufacturers are now required to update their quality system procedures, technical documentation, risk management processes, usability considerations, clinical data, post-market surveillance, vigilance practices, and labelling to meet these stringent requirements. Notably, the MDR and IVDR’s focus on safety replaces the Essential Requirements of the MDD, AIMDD, and IVDD with the comprehensive General Safety and Performance Requirements (GSPR), which consist of 23 principles, compared to the 13 principles of the Essential Requirements.
While many requirements from the MDD and AIMDD still apply under the MDR, there have been changes in classification rules for certain devices, such as software, devices composed of substances, devices incorporating nanomaterials, increased classification for high-risk devices, and inclusion of some products without a designated medical purpose under the MDR. As most IVD devices were previously self-declared under IVDD, except for specific higher risk devices, these devices now require assessment by a European Notified Body for CE certification under the IVDR.
Device and IVD Regulations in the European Union and USA FDA
Devices intended for the European and US markets must adhere to a quality management system. In Europe, the quality system must be certified to ISO 13485, with additional MDR/IVDR requirements assessed during conformity assessment procedures outlined in the regulations. In contrast, for the US FDA, compliance with the 21 CFR Part 820 Quality System Regulation is required.
Compliance with recognized standards is a means for demonstrating general safety and performance requirements and other legal requirements. The European Commission maintains a list of harmonized standards, and the MDR and IVDR encourage their consideration. Manufacturers must demonstrate compliance throughout the product’s lifecycle, and adopting updated versions of the standards is one way of achieving this. Similarly, the FDA provides a list of voluntary consensus standards which can be effective to address device safety, performance or substantial equivalence. Manufacturers are encouraged to use these FDA-recognized consensus standards in premarket submissions.
Conducting a Gap Analysis for EU MDR/IVDR Compliance
To navigate the transition to EU MDR/IVDR effectively, a comprehensive gap analysis of your device and quality management system against the MDR or IVDR requirements is recommended. To identify necessary updates and adjust your device’s technical file and quality management system documentation accordingly, the following steps should be considered:
Review the Device Technical File and Quality Management System
Assess your quality management system and device technical documentation, including procedures and processes for design, development, manufacturing, labelling, testing, post-market surveillance, reporting, vigilance, distribution, and more, against the EU MDR/IVDR requirements.
Identify critical gaps compared to the regulations, existing harmonized standards, guidance documents, and prioritize those that could impact product safety and effectiveness. Create an action plan detailing the necessary steps, timeframes, and resources for addressing each gap.
Implement the Action Plan
Execute the action plan to address identified gaps and required changes. Ensure that you adhere to the specified timelines for regulatory compliance. All stakeholders, including staff, contractors, and suppliers, should be well-versed in the requirements for effective and efficient compliance with the regulations.
Monitor Progress and Updates
Regularly review your progress to confirm the effectiveness and compliance of each action. Stay vigilant for updates to regulatory requirements and address any changes as necessary.
Optimizing the EU MDR/IVDR Transition Period
The EU MDR/IVDR transitional dates offer valuable opportunities for device manufacturers to prepare for compliance. It is essential to consider that Notified Body capacity for device assessments under MDR or IVDR is limited, with many manufacturers competing for these services as the transitional periods draw to a close.
To navigate delays and ensure EU MDR/IVDR device compliance, there are a number of steps to be observed:
Continuously check the European Commission’s website for updates to MDR and IVDR requirements, including revised guidance documents and harmonized standards. Adapt to evolving regulations and requirements.
Initiate the regulatory process well in advance of the specific transition date deadlines for your device type. Allow for potential delays and the time-consuming nature of conformity assessment activities, such as testing, validation, clinical studies, report writing, quality management system compliance, and Notified Body assessment.
Maintain a Relationship with the Notified Body:
Communicate with your chosen Notified Body to stay updated on certification timelines. Engage with them and secure an assessment slot to meet transition deadlines for continued market access in the EU, as wait times can be extensive due to high demand.
Ensure you allocate sufficient resources for MDR and IVDR compliance. Consider utilizing experienced regulatory professionals and consultants, including device developers with extensive knowledge and experience in this field.
Conduct a thorough gap analysis of your devices against MDR and IVDR requirements to effectively plan activities, testing, and documentation adjustments. This preparation ensures compliance with the regulatory requirements and a successful Notified Body conformity assessment for device certification.
If your device requires clinical data, begin collecting and analyzing the data early to avoid certification delays. Clinical studies are a time-consuming process.
Labelling and Documentation:
Ensure that your labelling and documentation meet MDR and IVDR requirements.
Post-Market Surveillance (PMS):
Establish a robust post-market surveillance system and post-market clinical follow-up system as required by the MDR and IVDR for ongoing monitoring of device safety and performance in the market.
Implement an effective risk management system compliant with MDR and IVDR requirements. This includes risk assessment, mitigation, planning, report preparation, and ongoing monitoring.
Implement a Vigilance system procedure and maintain transparent communication with regulatory authorities. Report any issues or incidents promptly, as required by MDR/IVDR.
The transition periods provide a critical window for manufacturers to plan and implement the necessary changes to ensure device and quality system compliance with the regulations. Strategic gap analysis and preparation are key to readiness for MDR/IVDR Notified Body assessment, certification, and market availability before the transition period concludes. Regularly check the European Commission’s website for the latest regulatory updates to stay informed and be prepared.