Clinical Investigation for Medical Devices under ISO 14155, EU MDR and India MDR 2017
REGHELPS plans and runs medical device clinical investigations end to end: clinical strategy, protocol and investigator’s brochure, ethics and regulatory approvals, site management, monitoring, data management, biostatistics and the final clinical investigation report for CE marking, FDA or CDSCO.
What is a clinical investigation for medical devices?
A clinical investigation is a systematic study in human subjects to assess the safety, clinical performance and clinical benefit of a medical device. It is the device equivalent of a clinical trial, and the strongest source of clinical evidence for your CE marking, FDA submission or CDSCO licence.
Clinical investigations are most often needed for implantable and Class III devices, novel technologies and new intended purposes where there is no equivalent device with enough clinical data. They must follow ISO 14155:2020 good clinical practice and the rules of each country where the study runs.
Do you need a clinical investigation for your device?
The decision flow we use with manufacturers planning CE marking under EU MDR. Final decisions depend on your device, claims and Notified Body.
Types of medical device clinical investigations
Device studies follow the device lifecycle. We help you choose the smallest study that will still convince your regulator.
| Study type | Typical design | Typical size | Typical duration |
|---|---|---|---|
| Early feasibility / first-in-human | Single-arm, prospective | 10–30 subjects | 6–12 months |
| Pivotal study | Randomised controlled or single-arm with performance goals | Determined by sample size calculation | 18–36 months |
| PMCF investigation | Prospective, within intended purpose (Article 74) | Driven by the clinical question | 12–36 months |
| Other investigations | Article 82, under national rules | Varies | Varies |
Clinical investigation requirements in the EU, USA and India
The same study can support several markets if it is planned for all of them from the start.
| Topic | European Union | United States | India |
|---|---|---|---|
| Legal basis | EU MDR Articles 62–82, Annex XV | 21 CFR 812 (IDE), 21 CFR 50 and 56 | Medical Devices Rules 2017, Chapter VII |
| Regulator | National competent authorities of each Member State | FDA (CDRH) | CDSCO, Central Licensing Authority |
| Ethics review | Ethics committee in each Member State | Institutional Review Board (IRB) | Ethics committee registered with CDSCO |
| Application | Annex XV Chapter II documents to each Member State | IDE application for significant-risk devices | Form MD-22; permission on Form MD-23 |
| GCP standard | ISO 14155:2020 | 21 CFR 812, with ISO 14155 accepted for many studies | ISO 14155 and Indian GCP |
| Registration | EUDAMED when fully functional; national systems now | ClinicalTrials.gov where applicable | Clinical Trials Registry of India (CTRI) |
EU MDR clinical investigation approval: step by step
How an application moves through a Member State under MDR Article 70.
Key documents we prepare for your clinical investigation
From clinical strategy to final report
REGHELPS runs your clinical investigation as a full-service CRO, with one team accountable from first plan to final report.
- 1
Clinical strategy
PlanningWe define what evidence your regulators need and design the smallest study that delivers it.
- 2
Protocol and study documents
CIP · IB · ICFWe write the CIP, investigator’s brochure, consent forms and CRFs to ISO 14155.
- 3
Approvals
Ethics · regulatorsWe prepare and manage ethics, Member State, FDA IDE or CDSCO submissions.
- 4
Site feasibility and selection
SitesWe find sites with the right patients and experience, and negotiate agreements.
- 5
Site initiation and training
Start-upWe train investigators and staff on the protocol, device and GCP.
- 6
Recruitment and consent
EnrolmentWe support patient recruitment and check consent is obtained properly.
- 7
Monitoring
Risk-basedOur monitors verify data and protect patient safety through on-site and remote visits.
- 8
Data management and safety reporting
eCRF · SAEWe manage data quality and report serious adverse events and device deficiencies on time.
- 9
Biostatistics and final report
CIROur biostatisticians analyse the data and we write the clinical investigation report.
- 10
CER and submission support
Close the loopWe integrate the results into your CER and support Notified Body, FDA or CDSCO questions.
Common clinical investigation pitfalls
Our clinical investigation services
Clinical investigation FAQs
When is a clinical investigation required under EU MDR?
Under MDR Article 61(4), clinical investigations are required for implantable and Class III devices, unless an exemption applies, such as demonstrated equivalence with full access to the equivalent device’s data, or certain well-established technologies. For other classes, an investigation is needed whenever existing clinical data is not enough to show safety, performance and clinical benefit.
How long does EU approval for a clinical investigation take?
After submission, the Member State validates the application within 10 days. Class I and non-invasive Class IIa and IIb devices may start right after validation unless national law says otherwise. Other devices need authorisation, which is normally decided within 45 days of validation, extendable by 20 days for expert consultation.
What documents are needed to start a clinical investigation?
The core set is the clinical investigation plan (CIP), investigator’s brochure (IB), informed consent form, case report forms, investigator CVs and agreements, insurance cover, ethics committee opinion, regulatory authorisation and, in the EU, the documents listed in MDR Annex XV Chapter II.
Do I need a clinical investigation to sell my device in India?
Under the Medical Devices Rules 2017, an investigational medical device needs a clinical investigation before it can be licensed, unless the Central Licensing Authority waives it, for example when the device is already approved in certain reference countries. Permission is requested on Form MD-22 and granted on Form MD-23, with ethics committee approval and CTRI registration.
What is ISO 14155?
ISO 14155:2020 is the international good clinical practice standard for clinical investigations of medical devices in humans. It covers study design, ethics, sponsor and investigator responsibilities, monitoring, safety reporting and documentation, and is harmonised under EU MDR.
What is the difference between clinical investigation and clinical evaluation?
A clinical investigation is a study that generates new clinical data in human subjects. Clinical evaluation is the ongoing assessment of all available clinical data, including investigation results, literature and PMCF, documented in the clinical evaluation report (CER).
How are serious adverse events reported in an EU clinical investigation?
Under MDR Article 80 and MDCG 2020-10/1, serious adverse events and device deficiencies that could have led to one must be reported to the authorities without delay: no later than 2 calendar days if there is an imminent risk of death or serious injury, and within 7 calendar days for other reportable events.
When must the clinical investigation report be submitted?
Under MDR Article 77(5), the sponsor submits the clinical investigation report within one year of the end of the investigation, or within three months if it is terminated early or halted, together with a summary that is easy for the intended user to understand.
Planning a clinical investigation for your device?
Share your device, class and target markets using the form below and we'll propose a study design and budget.
