From Idea to Bedside: How a Medical Device Actually Gets Approved

The blood pressure monitors at your GP surgery. The insulin pen used at home. The app tracking your heart rhythm. We trust these medical devices without a second thought, but few of us know what it actually takes for one to be approved for use.

Step 1: The Idea and Early Design

Medical devices play a fundamental role in modern healthcare, supporting the diagnosis, prevention, monitoring, and treatment of disease, as recognised by the European Commission [1]. Development typically begins when a clinician or engineer identifies an unmet clinical need and proposes a technical solution. Early-stage activities include securing intellectual property, building preliminary prototypes, and conducting initial bench or animal testing, often funded through personal investment or angel investors. For start-ups, delays in reaching first clinical use can threaten financial viability [2].

Early design decisions are shaped not only by technical feasibility but also by assumptions about who the device is for and where it will be used. Manufacturers frequently prioritise input from physicians, surgeons, and “clinical champions,” sometimes assuming that patient needs are best articulated through healthcare professionals. This can lead to a mismatch between those consulted during development and the individuals who ultimately use the device in practice [3].

These assumptions become more pronounced as devices move beyond hospitals into community and home settings. Many medical devices were originally designed for use in controlled clinical environments by trained professionals, and their transfer to the home introduces new safety and usability challenges. Reduced space, limited mobility, and home layout constraints may not support certain equipment, while patients’ concern for home aesthetics can influence acceptance and use. Large devices, such as dialysis machines, present additional challenges, and some devices are pre-programmed for hospital use before being deployed in the home. Nurses have reported difficulties setting up equipment such as infusion pumps, particularly when devices are outdated, poorly stored, or unsuitable for domestic settings, increasing the risk of error or contamination [4].

Commercial considerations also shape early design priorities. Medical device research is often driven by market potential rather than public health need, with limited attention to availability, accessibility, appropriateness, and affordability. As a result, device development may not reflect regional disease burdens or the needs of underserved populations, particularly in low- and middle-income settings [5].

Alongside concept development, manufacturers must consider regulatory classification, as this determines the level of scrutiny applied throughout the device lifecycle. Under the European Commission’s Medical Device Regulation (MDR) 2017/745, devices are classified using a risk-based framework that prioritises user safety. Based on factors such as invasiveness, energy source, duration of contact, and potential toxicity, devices are assigned to one of four main classes: Class I (low risk), Class IIa, Class IIb, and Class III (high risk) [1, 6]. While building on the earlier Medical Device Directive, the MDR introduces additional criteria that emphasise the vulnerability of the human body in relation to modern device design, making accurate classification at the design stage essential for defining subsequent evidence and regulatory requirements [7].

Step 2: Proving It Works and Is Safe

Demonstrating that a medical device is both effective and safe relies heavily on usability and performance evaluation. Common usability assessment methods include task analysis, scenario-based simulations, questionnaires, interviews, and focus groups. Some studies employ more complex, multi-step approaches incorporating cognitive analysis, human factors engineering, and man–machine interaction. Historically, however, manufacturers have taken a pragmatic approach to design, often centering development around senior medical staff who are involved in clinical validation and purchasing decisions, while limiting direct patient involvement to avoid added cost, extended timelines, or ethical approval requirements, all of which are perceived as barriers to rapid market entry [8].

Within usability engineering, a task is defined as one or more user interactions with a medical device to achieve a specific outcome. Task analysis systematically identifies all tasks involved in device use and examines their sequence and interdependencies. Findings are typically documented in tables or flowcharts, which help clarify how users interact with devices and where potential use-related risks may arise [9]. Assessing device performance is inherently complex and often involves a combination of bench testing, randomised controlled trials, and studies examining interactions between clinicians and emerging technologies such as artificial intelligence-enabled systems [10].

Under the Medical Device Regulation (MDR), clinical evidence requirements have become significantly more stringent. Generating an MDR-compliant Clinical Evaluation Report (CER) depends on the collection and appraisal of sufficient high-quality clinical data. For legacy devices, the robustness of available evidence varies widely, with manufacturers frequently relying on post-market surveillance (PMS) systems, including post-market clinical follow-up (PMCF) activities and systematic literature reviews. Due to increased regulatory expectations, many manufacturers of medium- and high-risk devices report plans to initiate new clinical investigations to support CE marking, often driven by changes in device design or intended use, gaps in clinical data, or previous reliance on claims of equivalence. These requirements introduce substantial time and financial pressures into the development process [11].

For first-time CE certification under the MDR, devices are classified using the 22 classification rules set out in Annex VIII. Compared with the earlier MDD/AIMDD framework, some devices are reassigned to higher risk classes, increasing the burden of proof for safety and clinical performance. Clinical evaluation is now a central component of technical documentation and must be conducted by a suitably qualified clinical evaluator with relevant specialist experience. While the MDR allows for clinical evaluation without clinical trials in many cases, higher-risk or novel devices may still require complex clinical investigations to adequately demonstrate safety and efficacy [12].

Step 3: Regulation - The Gatekeeper

Regulation acts as the primary safeguard ensuring that medical devices placed on the market are safe, effective, and subject to ongoing oversight. In the European Union, clinical evaluation is the cornerstone of this process, serving both as a pre-market requirement and a mechanism for long-term safety monitoring throughout a device’s lifecycle [13]. The regulatory landscape was significantly reshaped by the introduction of the Medical Device Regulation (MDR), developed in response to shortcomings in the previous directive-based system.

The demand for reform arose from the need to establish a regulatory framework that was transparent, robust, and sustainable, while simultaneously protecting public health and supporting innovation. Weaknesses in earlier EU directives became evident following high-profile safety failures, including the Poly Implant Prothèse breast implant scandal and the recall of metal-on-metal ASR hip implants. These incidents highlighted gaps in oversight, traceability, and post-market vigilance, resulting in patient harm and loss of public confidence in the regulatory system [14].

Unlike directives, the MDR is a binding regulation that applies directly across all EU Member States without the need for national transposition. This harmonised approach aims to ensure consistent patient protection, reduce regulatory fragmentation, and create a level playing field for manufacturers operating within the internal market. Improving patient safety remains the central objective of the MDR, and prior to its implementation, increased patient protection was widely viewed as the most significant anticipated benefit of the new framework [15].

Following the UK’s exit from the EU, medical device regulation has diverged legally while remaining aligned in principle. Great Britain now operates a distinct regulatory system, while Northern Ireland continues to follow EU rules. Despite this split, both systems retain core features such as risk-based classification, essential safety requirements, and obligations for pre- and post-market evidence generation. Conformity assessments are carried out by Notified Bodies in the EU and Approved Bodies in the UK, with device classification determining the applicable conformity route [16].

Since January 2021, manufacturers placing devices on the Great Britain market must comply with updated UK-specific requirements. These include the introduction of the UK Conformity Assessed (UKCA) marking, mandatory registration of all medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA), and the appointment of a UK Responsible Person for manufacturers based outside the UK. While UK notified bodies are no longer recognised by the EU and cannot issue CE certificates, transitional arrangements allow certain CE-marked devices to continue to be placed on the GB market until 2028 or 2030, depending on device type and applicable EU legislation. Medical devices in Great Britain continue to be regulated under the Medical Devices Regulations 2002 (as amended), which are derived from legacy EU directives and underpin current UKCA requirements [17, 18, 19].

Beyond Europe, regulatory policy is increasingly being used to balance patient safety with industrial development. In India, the National Medical Devices Policy 2023, approved by the Union Cabinet in April 2023, sets out a patient-centric vision to place the medical devices sector on an accelerated growth path. The policy aims to build an innovative and globally competitive industry supported by streamlined regulation, skilled manpower, and world-class infrastructure, while ensuring access to safe, affordable, and high-quality medical devices. In parallel with strengthening safety and quality, the policy outlines a long-term ambition for India to emerge as a global leader in medical device manufacturing and innovation, with a targeted increase in its share of the global market over the coming decades [20].

Step 4: After Approval

Approval does not mark the end of regulatory oversight for a medical device. Post-market surveillance (PMS) is a systematic process through which manufacturers proactively collect and review data on device performance once it is in real-world use. A key component of PMS is post-market clinical follow-up (PMCF), which involves the ongoing collection and analysis of clinical data to confirm continued safety and performance and to update the clinical evaluation accordingly. Under the MDR, manufacturers of Class IIb and III devices are required to submit Periodic Safety Update Reports (PSURs) at least annually, report any statistically significant increase in incidents, and comply with strengthened re-certification requirements, as device certificates are valid for a maximum of five years [21].

PMS activities are designed to identify device-related risks that may not have been evident during pre-market testing, including design limitations or use-related issues that can lead to patient harm. Although pre-market requirements are highly structured, real-world use can still result in serious incidents, underlining the importance of continuous monitoring once devices are deployed in healthcare settings [22]. To enhance the effectiveness of surveillance, artificial intelligence is increasingly being explored as a tool to improve signal detection, trend analysis, and the efficiency of PMS systems [23].

In the UK, suspected adverse drug reactions and medical device incidents can be reported to the MHRA through the Yellow Card Scheme, which accepts reports from healthcare professionals and the public via online, telephone, or postal routes [24]. At an EU level, PMS obligations apply to all devices, including custom-made devices, with manufacturers required to document post-production experience, implement corrective actions where necessary, and report serious incidents and field safety corrective actions without delay [25].

Post-market evidence is also increasingly shaped by technological developments in clinical care. Continuous monitoring of vital signs has been associated with improved patient outcomes, but traditional monitoring systems can restrict mobility and are difficult to implement on general wards. Wearable sensors and telemonitoring technologies offer promising alternatives, although robust evidence on their reliability and equivalence to existing clinical practice is still emerging, reinforcing the need for strong post-market data collection and evaluation [26].

Conclusion

Medical devices do not become safe and effective simply because they are approved; their true performance is revealed only through sustained use in real-world healthcare settings. As regulatory frameworks across the EU, UK, and India continue to evolve, the focus is shifting decisively from one-time market access to lifecycle governance, where clinical evidence, post-market surveillance, transparency, and accountability are continuous obligations rather than administrative checkboxes.

For manufacturers, regulators, and healthcare professionals alike, this means embracing data-driven monitoring, timely reporting of adverse events, and adaptive compliance as essential components of patient safety. For patients, it offers greater assurance that innovation in medical devices is not only rapid, but also responsible. In an era of increasingly complex technologies and globalised supply chains, robust post-market oversight is no longer optional, it is the foundation on which trust in medical devices is built.

References

1. Bianchini E, Mayer CC. Medical Device Regulation: Should We Care About It? Artery Research. 2022 Mar 31;28(2):55–60.

2. Kaplan AV, Baim DS, Smith JJ, Feigal DA, Simons M, Jefferys D, et al. Medical Device Development. Circulation. 2004 Jun 29;109(25):3068–72.

3. Money AG, Barnett J, Kuljis J, Craven MP, Martin JL, Young T. The role of the user within the medical device design and development process: medical device manufacturers’ perspectives. BMC Medical Informatics and Decision Making. 2011 Feb 28;11(1).

4. Tase A, Vadhwana B, Buckle P, Hanna GB. Usability challenges in the use of medical devices in the home environment: A systematic review of literature. Applied Ergonomics. 2022 Sep;103:103769.

5. World Health Organization. Medical devices: managing the mismatch: an outcome of the priority medical devices project [Internet]. www.who.int. 2010. Available from: https://www.who.int/publications/i/item/9789241564045

6. Aronson JK, Heneghan C, Ferner RE. Medical Devices: Definition, Classification, and Regulatory Implications. Drug Safety. 2019 Dec 16;43(2):83–93.

7. Peter L, Hajek L, Maresova P, Augustynek M, Penhaker M. Medical Devices: Regulation, Risk Classification, and Open Innovation. Journal of Open Innovation: Technology, Market, and Complexity. 2020 Jun 10;6(2):42.

8. Roma MSG, de Vilhena Garcia E. Medical device usability: literature review, current status, and challenges. Research on Biomedical Engineering. 2020 Feb 15;36(2):163–70.

9. Shin J, Lee H. Optimal Usability Test Procedure Generation for Medical Devices. Healthcare. 2023 Jan 18;11(3):296.

10. Cherubini A, Dinh NN. A Review of the Technology, Training, and Assessment Methods for the First Real-Time AI-Enhanced Medical Device for Endoscopy. Bioengineering [Internet]. 2023 Apr 1;10(4):404. Available from: https://www.mdpi.com/2306-5354/10/4/404

11. Kearney B, McDermott O. The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study. Therapeutic Innovation & Regulatory Science [Internet]. 2023;57(4):783–96. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276779/

12. Zenner HP, Božić M. Clinical Evaluation of Medical Devices in Europe. In: Europeanization and Globalization. Cham: Springer International Publishing; 2019. p. 21–32.

13. Manu M, Anand G. A review of medical device regulations in India, comparison with European Union and way-ahead. Perspectives in Clinical Research. 2021;0(0):0.

14. Huusko J, Kinnunen UM, Saranto K. Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals. BMC Health Services Research [Internet]. 2023 Mar 30;23(1). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10062684/

15. Carl AK, Hochmann D. Impact of the new European medical device regulation: a two-year comparison. Biomedizinische Technik. 2023 Nov 13;0(0).

16. Quigley M, Downey L, Mahmoud Z, McHale J. The Shape of Medical Devices Regulation in the United Kingdom? Brexit and Beyond. Law, technology and humans. 2023 Nov 21;5(2):21–42.

17. Jeffery S. The regulation of medical devices in the UK: recent changes. British Journal of Nursing. 2022 Feb 24;31(4):S4–6.

18. Kwong MT, Stell D, Akinluyi E. Medical Device Regulation from a Health Service Provider’s Perspective. Prosthesis. 2021 Sep 14;3(3):261–6.

19. Medicines and Healthcare products Regulatory Agency. Regulating Medical Devices in the UK [Internet]. GOV.UK. 2020. Available from: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

20. Ministry of Chemicals & Fertilizers Government of India. Strategy Document on NATIONAL MEDICAL DEVICES POLICY [Internet]. 2023 [cited 2026 Feb 2]. Available from: https://pharma-dept.gov.in/sites/default/files/Strategy%20Document%20on%20NMDP%202023_0.pdf

21. Fraser AG, Byrne RA, Kautzner J, Butchart EG, Szymański P, Leggeri I, et al. Implementing the new European Regulations on medical devices—clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology. European Heart Journal. 2020 Jun 2;41(27):2589–96.

22. Badnjević A, Pokvić LG, Deumić A, Bećirović LS. Post-market surveillance of medical devices: A review. Technology and Health Care. 2022 Aug 4;30(6):1–15.

23. Tushar Khinvasara, Nikolaos Tzenios, Shanker A. Post-Market Surveillance of Medical Devices Using AI. Journal of Complementary and Alternative Medical Research [Internet]. 2024 Jun 29;25(7):108–22. Available from: https://journaljocamr.com/index.php/JOCAMR/article/view/552

24. O’ Donovan B, Rodgers RM, Cox AR, Krska J. Identifying and managing adverse drug reactions: Qualitative analysis of patient reports to the UK yellow card scheme. British Journal of Clinical Pharmacology. 2022 Mar 23;88(7).

25. Medical Device Coordination Group (MDCG). Medical Devices [Internet]. 2025 Dec [cited 2026 Feb 2]. Available from: https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf

26. Haveman ME, van Melzen R, Schuurmann RCL, El Moumni M, Hermens HJ, Tabak M, et al. Continuous monitoring of vital signs with the Everion biosensor on the surgical ward: a clinical validation study. Expert Review of Medical Devices. 2021 Dec 3;18(sup1):145–52.

Assessed and Endorsed by the MedReport Medical Review Board