Regulatory Landscape
Each country has its own MD legislation. When discussing the hierarchy of requirements it begins with legislation (regulations), which are mandatory and must be complied with. Unlike regulatory requirements, which are mandated by law and must be strictly adhered to, guidance documents and standards are voluntary. However, following these guidelines and standards often provides a clear pathway to regulatory approval.
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MD Requirements Hierarchy |
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UK |
EU |
US |
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MDR 2022 (based on EU Directives MDD 93/42/EEC, and IVDD (98/79/EC) |
MDR 2017/745 and MDR 2017/745 |
US Code of Federal Regulations (CFR) |
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Designated standards |
Harmonised standards |
Recognised standards |
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National standards |
National standards |
National standards |
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Guidance documents |
Guidance documents |
Guidance documents |
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Local procedures |
Local procedures |
Local procedures |
For an overview of MD regulatory landscape please refer to the CETC “Regulatory Roadmap for UofG MedTech Developers “ guideline (link to GUI_MD_85.001 here).
To establish the regulatory strategy, one first needs to confirm that a product is classified as an MD. Once confirmed, the next steps are to determine its risk classification and the appropriate conformity procedure.
Is my product a medical device?
One can determine if a product meets the definition of a MD using RegMetrics or by referring to the corresponding articles found in the published UK and EU legislation.
Click on the links below for references to the legislation that defines MD and IVD in the UK and EU .
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(UK) MDR 2022 (based on EU Directives MDD 93/42/EEC, Article 1 and IVDD (98/79/EC) |
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(a) ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means (b) ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device (c) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
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(1)‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. |
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The following products shall also be deemed to be medical devices:
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If the innovator intends to develop a product which satisfies one of the definitions above, it will be a medical device and will be regulated under the appropriate medical device legislation. |
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What is the classification of the device?
MDs are categorised according to their potential risk to patients, with classification determined by factors such as how they interact with the human body and their associated hazards. Each of the rules described in the legislation should be considered, and the highest classification will be the overall classification for the device.
To determine the classification of an MD, one can use RegMetrics or consult the published legislation and guidelines for classification details (links in the table below).
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Classification of MD (Legislation) |
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UK |
(18 Rules) |
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EU |
(22 Rules) |
Additionally, CETC Form MD 85.002 contains information on how to navigate UK and EU legislation and guidance documents to determine MD classification based on MDCG guidance document for MD classification.
MHRA created a useful diagram for medical device classification in the UK found in the introductory guide to the MDR and IVDR pdf guide
Conformity procedures
Once the risk classification is determined, this will help determine the conformity assessment procedure approach. This is because the regulatory requirements and associated burdens will vary significantly based on the risk classification, impacting the amount of evidence needed and the overall costs involved.
The Conformity Procedures are outlined in the UK and EU legislation – links in the table below
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Conformity procedures - MD Legislation |
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UK |
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EU |
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For more information on conformity procedures and some of the legal requirements and initiatives that may need to be considered for regulatory approval of MDs in UK and EU, please read the “Regulatory Roadmap for UofG MedTech Developers“ guideline (link to GUI_85.001 here).
Essential Requirements (ERs) and General Safety and Performance Requirements (GSPRs)
After establishing the conformity procedure, the next step is to identify the Essential Requirements (a term used in the UK) or the General Safety and Performance Requirements (GSPR) as referred to in the EU. These terms essentially refer to the same set of criteria.
The ERs and GSPRs are outlined in the UK and EU legislation – links in the table below:
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UK and EU MD Legislation |
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Essential requirements (UK) |
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General Safety and Performance Requirements (GSPRs) |
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Additional information on ERs and ESPRs can be found in the “Regulatory Roadmap for UofG MedTech Developers “ guideline (link to GUI_85.001 here).
The most efficient way to present the ERs and GSPRs is by creating a table that lists all of them in the order specified in the relevant UK or EU legislation, indicating whether each requirement is applicable. For certain medical devices, some ERs/GSPRs may not apply; in these instances, justifications for their exclusion should be provided. If the ERs and GSPRs are applicable, manufacturers must provide evidence demonstrating that solutions have been implemented to meet these requirements. This evidence should include the standards used to comply with the legislation, along with a list of all documents that substantiate their compliance.
You can contact CETC directly for guidance and signposting to ER and GSPR checklist resources.
Standards
MD development is governed by a comprehensive set of standards that apply throughout the entire lifecycle - from initial concept through design, manufacturing, commercialisation, and eventual retirement or replacement to ensure safety, efficacy, and quality.
There are over a thousand ISO standards, with more than 300 specifically related to medical devices. Utilising the ER/GSPR checklist can help identify the relevant standards applicable to the specific technology in question.
The UofG library provides access to UofG staff and students to a large number of BSI, ASTM, ASME, ISO and IEC standards that apply to various MedTech
(Link here: https://bsol-bsigroup-com.ezproxy1.lib.gla.ac.uk/ )
Additional information on ways to identify the standards applicable to a specific MedTech can be found in the CETC guideline MD_85.004 “Overview of Healthcare Standards Used in MedTech Development”
Technology Readiness Levels (TRL) and definitions
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Technology readiness levels (TRLs) serve as a measurement system to assess the maturity level of a particular technology, evaluated according to the criteria for each TRL, allowing it to be assigned a rating based on its progress. The CETC offers support to UofG researchers according to the stage of product development. This support encompasses activities up to TRL8 before a business is incorporated (pre spin-out) as well as pre sell-out or pre licence-out. As illustrated in this roadmap, engagement with Patient and Public Involvement and Engagement (PPIE) groups is essential throughout the entire life-cycle of product development. For guidance on PPIE support, please contact the CETC PPIE manager. The roadmap outlines a streamlined workflow that summarises the key activities and considerations for the development, evaluation and commercialisation of MDs, aiming to facilitate their effective translation into clinical practice. The TRL levels and definitions are as follows: | |
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| TRL 1: Basic principles observed and reported |
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TRL 2: Technology concept or application formulated |
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| TRL 3: Analytical and experimental critical function or characteristic proof-of-concept |
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| TRL 4: Technology basic validation in a laboratory environment |
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| TRL 5: Technology basic validation in a relevant environment |
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| TRL 6: Technology model or prototype demonstration in a relevant environment |
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| TRL 7: Technology prototype demonstration in clinical environment |
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| TRL 8: Actual technology completed and qualified through test and demonstration and regulatory approval |
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| TRL 9: technology launched | |
| TRL10: Post Market Surveillance |
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What TRL stage are you at in your MedTech development journey? See the following sections to learn about the steps involved in MedTech development and the support available from CETC at each stage of the process. | |
Defining Evidence Generation
Evidence generation for medical device development is a comprehensive process of collecting, analysing, and documenting data that substantiates the safety, efficacy, and value of a new device. This systematic approach encompasses laboratory testing, clinical trials, real-world evaluations, and economic assessments that collectively demonstrate the device meets regulatory requirements and addresses genuine healthcare needs.
Evidence generation begins early in Medtech development with preliminary research to identify unmet clinical needs and continues through design verification, validation testing, clinical investigations, and post-market surveillance. This robust body of evidence serves multiple critical functions: supporting regulatory submissions for approval, informing healthcare provider adoption decisions, justifying reimbursement from payers, and ultimately ensuring that patients receive medical technologies that are both safe and effective. A well-executed evidence generation strategy addresses technical performance, clinical outcomes, user experience, implementation factors, and economic impact—providing a complete picture of the device's benefits and risks within its intended healthcare context.
Requirements for the evidence generation at each TRL level are outlined below in each individual section.
2.1.1 Idea and Unmet Clinical Need
In the early stages of MedTech development, the UofG innovator should clearly define the Unmet Clinical Need and Intended Use and initiate Risk Identification & Management Processes.
Unmet Clinical Need
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Conduct comprehensive research to determine the potential benefits of the proposed MedTech solution compared to the current standard of care. This understanding will help gauge whether patients and clinicians are aligned or not in their needs.
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Focus groups (FG) and Patient and Public Involvement and Engagement (PPIE) activities are essential for crafting a project plan that effectively addresses the unmet clinical need.
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For guidance on PPIE support, please contact the CETC PPIE manager. Additionally for digital health technologies, DHVL (include hyperlink) can assist with PPIE activities and FG involving both clinicians and NHS patients. Please note that FG and PPIE activities have financial implications and should be planned in research grant applications.
At TRL 3-4 it is important to begin the regulatory documentation process for the MedTech product. For guidance and signposting to resources covering the following topics, please contact CETC directly:
- Intended Use Statement
- Device Description
- Device Classification
- Initiation of Risk Management Process
2.1.2 Intellectual Property (IP)
Engagement with business experts can help determine if the MedTech product is a novel invention, ensure freedom to operate and protect any resulting intellectual property.
If the technology is innovative and patentable , it is important to engage with the UofG IP & Commercialisation team, which is part of the Research & Innovation Services Directorate.
The IP& Commercialisation team assists researchers in identifying, evaluating, protecting, and developing new innovations. Their ultimate goal is to help transfer these innovations outside the university for societal and economic impact before any public disclosure occurs.
All researchers with potentially commercialisable research results should contact the relevant IP officer for assistance.
2.1.3 TRL 1-4 Evidence Generation at the early MedTech development stage
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2.1.3.1 Preliminary (desktop) research: |
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2.1.3.2 Healthcare Professional engagement: |
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2.1.3.3 Documentation |
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2.2.1 TRL 5-6 Evidence Generation at the pre-clinical stage of MedTech development
It is crucial to understand the patient and clinician needs, as the MedTech prototype and any research study approach has to meet all of the essential requirements expressed by clinical care providers and patient and public contributors (PPI)
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2.2.1.1 Patient / public engagement: |
For guidance on PPIE support, please contact the CETC PPIE manager. |
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2.2.1.2 Healthcare Professional engagement |
Additionally for digital health technologies, DHVL can assist with PPIE activities and FG involving both clinicians and NHS patients. Please note that FG and PPIE activities have financial implications and should be planned in research grant applications. |
| 2.2.1.3 Early health economist engagement |
For more information on health economics support, please contact the UofG Health Economics and Health Technology Assessment (HEHTA) |
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2.2.1.4 Regulatory engagement |
The technical file documentation are living documents that need to be updated along with the evolving technology. For more information, please reach out to the CETC Innovation Start-up Manager. They can provide guidance and signpost to resources for the early development of a Quality Management System (QMS) framework and Technical File (TF). They can also assist with identifying and engaging with suitable external regulatory consultants. |
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2.2.1.5 MedTech Prototype evaluation |
The UofG does not have product liability insurance (as expected for manufacturers of medical devices) for the prototype but its use in research (as a research tool) is covered by our standard clinical research insurance policy (confirmed by our insurance underwriters). For MedTech prototypes developed at UofG, CETC and DHVL can be contacted to link with West of Scotland Innovation (WoSI) for sponsor engagement. If WoSI can support the research study in a sponsor capacity, then a sponsor review with relevant safety tasting will be required in order to perform basic research studies involving NHS patients. The sponsor may require additional outsourced safety tests. It is important to note that the safety tests activities have financial implications and should be planned in research grant applications. The relevant ISO standards should be aligned for various stages of MedTech Prototype development as outlined in CETC guideline MD_85.004 “Overview of Healthcare Standards Used in MedTech Development” (hyperlink here for 85.004) |
2.3.1 Clinical Trial Product
When transitioning to the manufacture of a ‘clinical prototype’, it is crucial to determine who will act as the manufacturer. The manufacturer is accountable for the design, manufacturing, packaging, and labeling of the product intended for the clinical trial, regardless of whether these tasks are conducted by them directly or by a third party on their behalf.
By the time a product reaches the clinical trial stage, typically at TRL 8 it is common for the product to be spun-out, licensed out or sold out, leading it to follow the commercial NHS clinical trial pathway.
If the business is still at the pre-incorporation stage, additional indemnity coverage is necessary, as the UofG is only authorised to use the technology as a research tool for research purposes.
The CETC can provide support for Clinical trials grant applications via the CETC Trial Application Prioritisation Review (TAP) process.
2.3.2 Clinical evaluation
Medical device manufacturers are required to conduct a clinical evaluation to compare a new device against standard of care practices, or established similar devices. This process involves several considerations, including financial implications, manufacturing processes, and compliance with regulatory and ethical standards.
The clinical evaluation should include a literature review and trials to assess the device's efficacy and safety. This evaluation is crucial for obtaining pre-market approval and promoting the adoption of the new device.
Additionally, manufacturers must undertake a risk-benefit assessment of the new device in actual clinical conditions of use. For further details on the clinical evaluation process, refer to the CETC Guidance Document 85.005.
2.3.3 Clinical investigation
The MHRA published guidance on Clinical investigations for medical devices.
The MHRA flowchart can be used to decide if the study is required to be submitted as a formal clinical investigation in Great Britain (link)
A feasibility/proof-of-concept study qualifies as a clinical investigation under MHRA if the study:
- Involves human participants
- The device has a medical purpose
- The device is not CE-marked for the intended use
- The device is not exempt from regulation
Following on from the feasibility study, a pivotal study will build on feasibility data and may involve larger, more diverse cohorts to support UK-CA marking and market readiness.
All Clinical investigations should comply with ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects - Good clinical practice” is an international standard for studies involving human subjects that evaluate the safety and performance of medical devices for regulatory purposes.
The MHRA may request access to the Technical File (via the sponsor) for the proposed MedTech device to check for safety reports, such as biocompatibility and toxicology as well as other evidence for meeting the essential safety requirements. For a company to share their TF, a non-disclosure agreement might need to be in place with NHSGGC. MHRA will provide a secure link for this information to be sent as part of the MHRA application.
Sponsorship
The decision regarding sponsorship is made jointly by the NHSGGC R&I and UofG Head of RRC. The UofG may act as a Co-Sponsor alongside NHSGGC for trials involving technologies developed at UofG or for UofG investigator initiated trials involving commercially developed devices. Decisions on sponsorship for medical technology device trials will be made on a case-by-case basis. Once funds for the clinical trial are confirmed, the sponsor will review the documentation to be sent to IRAS and MHRA and authorise both IRAS and MHRA applications.
2.3.4 Important PPI considerations
As outlined previously, it is crucial to understand the patient and clinician needs as the MedTech device and trial approach has to meet all of the essential requirements expressed by clinical care providers and patient and public contributors (PPI).
PPIE input is required from the grant application stage throughout the project duration to ensure that research is carried out ‘with’ and influenced ‘by’ members of the public or potential patients. PPIE members may act as advisory members of a project steering group. For guidance on PPIE support, please contact the CETC PPIE manager.
NHS Clinicians are consulted for input on grant applications, trial protocol and trial oversight.
The health economist engagement is required for cost-effectiveness evaluation and the economic evaluation plan.
2.3.5 Documentation
The development of a Technical File, while resource-intensive from the beginning, significantly enhances the commercial appeal and value of a product to potential buyers. This is because it eliminates the need to ‘back-fill’ the history and results of the device's design, manufacturing, and testing processes.
These living documents must be updated with additional information acquired during the clinical evaluation and investigation stages.
For more information, please reach out to the CETC Innovation Start-up Manager. They can provide guidance and signpost to resources for the early development of a Quality Management System (QMS) framework and Technical File (TF). They can also assist with identifying and engaging with suitable external regulatory consultants.For additional information please refer to Section 4 - Guidance and signposting to resources for early phase development of a Quality Management System (QMS) framework and Technical File (TF).
2.3.6 Financial Implications
Clinical investigation of devices has significant costs that must be met that can range from £0.5 mil for a Class I self-certified device to £5-6 mil for Class II and Class III devices.
UofG research support teams such as MedTech IF, the TRI, CETC can support MedTech innovators in identifying, attracting and managing public, commercial, investor and philanthropic funding for clinical studies of devices, appropriately costed in partnership with the NHSGGC.
2.3.7 Regulatory approval for Clinical Trials
Medical device developers require local, national and international approvals for device evaluations in the NHS and must engage with the sponsor organisation and regulators in advance to identify and address potential hurdles to authorisations. The UofG RRC Office supports UofG innovators in these areas.
3.1 Quality Management System (QMS)
ISO 13485 - is the international standard for the Quality management system (QMS) in the medical device industry specifically designed for the medical device industry.
This standard addresses the unique requirements of medical device legislation and encompasses all stages of the medical device lifecycle, including design and development, production, storage, distribution, installation or servicing, and post-market activities.
CETC provides guidance and signposting to help UofG innovators incorporate effective regulatory and quality practices early in the development process without placing an excessive burden on research teams. By adopting QMS Lite, research groups can can establish a solid foundation for ISO 13485 readiness, thereby enhancing the robustness and efficacy of their solutions.
3.2 Technical Documentation
The Technical File (TF) prepared by the MedTech developer details all evidence of compliance with the medical device regulation. It also considers the specific ISO requirements and guidelines relevant to the technology.
CETC provides guidance and signposting to assist in developing an early-phase medical device Technical File that meets the required regulatory standards.
For support and signposting to resources related to the early-phase development of a Quality Management System (QMS) framework and Technical File, please contact CETC directly.