Article

 

Posted by Miss. Asha Johnson on November 6th, 2017

This article is for informational purposes only and is not intended to provide legal advice.

Legal interpretations and questions regarding MDR Article 61 / MedDev 2.7/1.Rev 4 business or regulatory compliance should be directed to regulatory compliance departments by email enquiry@i3cglobal.com

To ensure a successful development and launch of your new or modified medical device, I 3 CONSULTING offers service and technical expertise to do Clinical Evaluation of the medical device.

I 3 CONSULTING can help you in designing and performing bench tests and acute and/or chronic animal studies. Those studies can serve as product design verification and validation. Thus, those studies will support the essential requirements (Medical Device Directive, 93/42/EEC, Annex I) and global regulatory filing.

I 3 CONSULTING provides the following services:

• Identify standards/guidelines and requirements for in vitro and in vivo testing
• Develop product testing strategy in compliance with identified requirements
• Design, coordinate and/or perform testing

The outcome of pre-clinical investigations can be used to get early customer feedback on medical devices. This feedback can be used to improve your product design, to define your marketing strategy and your product positioning in the regulated markets.

What is Clinical Investigation? How I 3 CONSULTING can help?

 

The clinical investigation, according to MEDDEV 2.7/4 is defined as “any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and or performance of a medical device”.

I 3 CONSULTING can help you to manage your clinical study by assisting you with:

• the selection of the appropriate clinical strategy
• the selection of suitable investigators
• the Design of clinical plans and conformity with the European harmonized standards EN ISO 14155 series
• the Insurance coverage
• the Applications/Notification to Ethical committees and European competent authorities
• the Study initiation and monitoring
• Data management and analysis

Clinical Evaluation Report is a continuous process conducted throughout the life cycle of a product based on a comprehensive analysis of available pre-and post-market clinical data relevant to the intended use of the device in question, including clinical performance data and safety data. This includes data specific to the device in question as well as any data relating to devices claimed as equivalent by the manufacturer. The outcome of this process is a Clinical Evaluation report which includes a conclusion on the acceptability of risks and side effects when weighed against the intended benefits of the device.

Clinical Evaluation must be focused on the following factors:

• Review of Literatures applicable to the device
• Residual Risks as per ISO 14971
• IFU warnings and contraindications
• Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF)
• Clinical Trials (if required)

How we assist and what assurance we provide?

We assist in preparing clinical evaluations for your products by applying MEDDEV 2.7.1 Rev 4. The evaluation of clinical data is not only of prime importance for the official approval process for CE mark certification and product launch in Europe but also for the continuing market surveillance in the field of medical devices.

We help clients in the evaluation of clinical data documented as Clinical Evaluation Report with related documents which is part of the technical documentation and conformity assessment/CE marking process, followed by assisting you with submission to the notified body as part of the official approval process for your medical device(s).

When needs a Clinical Evaluation Report Update?

Clinical evaluation should be revised in regular intervals as and when new risks are identified through PMS and if no significant risks have been identified.

Thanks for reading this article.
Miss. Asha Johnson [Jr. Consultant]

More details are available at home page of the website www.i3cglobal.com