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A pre-market clinical investigation, i.e., one performed on a device not yet CE marked, should comply with the MDR.

When conducted under the MDR, they must also comply with any applicable common specification, defined in Article 2(71) of the MDR as a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.


Pre-market clinical investigations are usually conducted to produce clinical data to support clinical performance and/or safety in the context of CE marking.


You're planning to CE mark your medical device? Contact our team to find out how our services can help you at this crucial time.


The MDR provides extensive requirements for clinical investigations compared to the guidelines.

Several articles of the MDR address this matter, particularly articles 62 to 80:
– General requirements for clinical investigations conducted to demonstrate device compliance.
– Informed consent
– Clinical investigations on subjects requiring special attention
– Application process and evaluation by Member States
– Conduct of the clinical investigation
– Electronic system on clinical investigations and other aspects

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Our seasoned physicians and clinical research professionals assist you in the planning, management and evaluation of clinical trials.  They can help you design robust protocols by advising on study goals, eligibility criteria, study evaluation and design options, and writing MDR-compliant protocol synopses.

Protocols are designed to enable timely patient recruitment and provide robust answers to scientific questions. You will benefit from strong clinical study oversight, which is key to a successful, timely and cost-effective medical device development process.



Take advantage of our well-established clinical SOPs to conduct a compliant clinical trial.

Eclevar has developed clinical investigation SOPs that ensure compliance with the MDR, ISO 14155, and any other applicable standards and requirements in other regulatory jurisdictions where a clinical investigation may be conducted.


By partnering with Eclevar, you benefit from our established ecosystem of many hospitals in France.

Our team of experts can help you identify, select and recruit the appropriate site for your trial based on your medical device and challenges.

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Manufacturers may lack the internal resources to conduct their clinical studies. It is then recommended to outsource certain responsibilities in order to avoid unacceptable risks linked to the involvement of inexperienced actors.

Our clinical research professionals, who have published over 100 scientific papers, can assist you in all phases of clinical development.


Acting as an advisory body to Eclevar, it participates in the development of medical and clinical methodologies/technologies and provides advice on scientific strategy to the management team.

Its members are eminent scientists with proven scientific excellence. Their skills and experience cover the disciplines relevant to Eclevar's mission.

Eclevar also has an international team of leading KOLs at leading hospital sites across all key therapeutic areas who provide medical oversight and expertise to projects.

Other key considerations for the selection of a partner for medical device & diagnostic CRO:


The quality of work is directly linked to compliance with the regulation. It is important to ensure that the medical device CRO Or IVD CRO holds the relevant quality standard documents ISO14155 (European regulation), ISO9001, and ISO13485.


Clinical trial Capabilities

Does the clinical research organization have global capabilities and partnerships for the regions where the study will be performed in? Studies often involve working with several vendors so having the full-service capabilities of a clinical research organization will help. Is the CRO able to provide efficiencies for a project for example in providing a CTMS (clinical trial management system)? 



This can be key a factor in selecting a clinical research organization. Comparison with other CROs needs to be comparable (i.e apples with apples) such as comparing unit costs/line items and not overall cost. Does the CRO provide transparency around pass-through costs which can often impact the cost of the clinical trial or PMCF study? If the project costs look very low have all the study specifications included as in future costs may increase significantly with multiple pass-through costs.

This process can be managed by the sponsor for setting the same expectations when assessing clinical research organizations in the process of RFI(request for information) and/or RFP. Implementing a standard comparison process can provide the same set of questions and scope of work for medical device CROs to respond.