From Reviewer to Consultant: Transforming Regulatory Affairs in the MDR Transition
Abstract
The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) introduced stringent requirements for clinical evidence, device reclassifications, and more robust post-market surveillance measures, creating significant challenges for the medical technology industry. The compliance of a portfolio exceeding 2,500 products within Dräger's Hospital Consumables and Accessories (HCA) Business Unit was managed, with MDR certification achieved prior to the regulatory deadline of May 26, 2024.
The study examines a methodological shift in Regulatory Affairs (RA) from a post-development review function to a proactive consultancy role. By optimizing processes, driving cultural change, and embedding RA expertise early in the R&D V-Model alongside Product Management (PM), this methodology streamlined development timelines, reduced costs, and prioritized resources for critical markets. The result was enhanced operational efficiency and adaptability on a global scale.
Downloads
References
https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng
2. European Commission. Council Directive 93/42/EEC [Internet]. Brussels: European Commission; 1993 [cited 2025 Oct 29]. Available from:
https://eur-lex.europa.eu/eli/dir/1993/42/oj/eng
3. Kearney B, McDermott O. The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study. Ther Innov Regul Sci. 2023 Jul;57(4):783-796.
doi: 10.1007/s43441-023-00527-z.
4. Drägerwerk AG & Co. KGaA. Home [Internet]. Lübeck: Drägerwerk AG & Co. KGaA; 2025 [cited 2025 Oct 29]. Available from: https://www.draeger.com/en-us_us/Home
5. Wagner H. US-9566427-B2: Apparatus and method for electrostimulation of the retina [Internet]. Washington: U.S. Patent and Trademark Office; 2016 [cited 2025 Oct 29]. Available from:
https://patentimages.storage.googleapis.com/42/e0/4d/e3d9496d258dd5/US9566427.pdf
6. ISO. ISO 13485:2016 – Medical devices – Quality management systems [Internet]. Genf: International Organization for Standardization; 2016 [cited 2025 Oct 29]. Available from:
https://www.iso.org/standard/59752.html
7. International Organization for Standardization. ISO 9001:2015 – Quality management systems – Requirements [Internet]. Genf: ISO; 2015 [cited 2025 Oct 29]. Available from:
https://www.iso.org/standard/62085.html
8. Altshuller G. The innovation algorithm: TRIZ [Internet]. Worcester: Technical Innovation Center; 1999 [cited 2025 Oct 29]. Available from:
https://the-trizjournal.com/book-review-altshullers-innovation-algorithm/Patent
9. International Organization for Standardization. ISO 14971:2019 – Medical devices — Application of risk management to medical devices [Internet]. Genf:ISO; 2019 [cited 2025 Oct 29]. Available from:
https://www.iso.org/standard/72704.html.
10. MedTech Europe. MDR implementation impact report 2024 [Internet]. Brussels: MedTech Europe; 2024 [cited 2025 Oct 29]. Available from:
https://www.medtecheurope.org/wp-content/uploads/2022/07/medtech-europe-survey-report-analysing-the-availability-of-medical-devices-in-2022-in-connection-to-the-medical-device-regulation-mdr-implementation.pdf
11. U.S. Food and Drug Administration. Quality System Regulation (QSR) [Internet]. Silver Spring: US FDA; 2025 [cited 2025 Oct 29]. Available from:
https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp
12. U.S. Food and Drug Administration. Quality Management System Regulation (QMSR) Final Rule [Internet]. Silver Spring: US FDA; 2023 [cited 2025 Oct 29]. Available from:
https://www.thefdagroup.com/blog/qmsr-quality-management-system-regulation
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
