Combination Product
Let Kickfile’s systems facilitate your compliance efforts.
Regardless if you have an integral or a co–packed combination product you must comply with certain aspects of the medical device regulation. Our systems can facilitate your compliance efforts.
For qualifying drug–device combination products, marketing authorization dossiers should include conformity assessment results or CE mark issued by a Notified Body for the device component.
Manufacturers of drug–device combination products should be aware of the changes introduced by Article 117 of the MDR, which requires manufacturers placing drug–device combination products onto the market as an integral device and marketing them as a medicinal product to seek notified body opinion. As part of this process the notified body confirms whether the device part of the product is compliant with the relevant General Safety and Performance Requirements.
These are the service needed for combination products
Clinical Evaluation
The increased requirement of the clinical evaluation process became clear already in 2016 when the 4th revision of the MEDDEV 2.7/1 was published. Since then the importance of the clinical evaluation has been increasingly stressed in the EU Medical Device Regulation (MDR 2017/745). Let Kickfile’s system guide you through the requirements and provide you with a document structure that has gone through a multitude of Notified Body reviews.
The increased requirement of the clinical evaluation process became clear already in 2016 when the 4th revision of the MEDDEV 2.7/1 was published. Since then the importance of the clinical evaluation has been increasingly stressed in the EU Medical Device Regulation (MDR 2017/745). Let Kickfile’s system guide you through the requirements and provide you with a document structure that has gone through a multitude of Notified Body reviews .
Clinical evaluation is an ongoing process to collect, appraise and analyze clinical data throughout the life cycle of a medical device. In general, it is first performed during product development to identify data that need to be generated for market access. Clinical evaluation is mandatory for initial CE - marking and must be actively updated thereafter.
Clinical evaluation is necessary and important because it ensures that the evaluation of safety and performance of the device is based on sufficient clinical evidence throughout the lifetime that the medical device is on the market.
Whether you are developing a new medical device or need to update your clinical evaluation Kickfile’s system provides you with the tools that you need to ensure compliance with MEDDEV 2.7/1 rev. 4 and MDR.
Clinical Investigation
A clinical investigation is a complex process with a comprehensive regulatory framework. Our system guides you through all the steps needed for your clinical investigation, regardless if it is a pre-or post-market study, and makes your journey from study idea to fully executed investigation swift, transparent and agile.
Regardless of the reasons for initiating a clinical investigation, it comprise of a widespread process and comprehensive regulatory framework. Clinical investigations must take into account scientific principles underlying the collection of clinical data along with accepted ethical standards surrounding the use of human subjects that have their origin in the Declaration of Helsinki.
According to ISO 14155 and the MDR, the sponsor shall implement and maintain written quality procedures to ensure that the clinical investigation is designed, conducted and reported in compliance with ISO 14155, the clinical investigation plan (CIP), any subsequent amendments, and any other applicable standards and regulatory requirements.
Establishing and maintaining a clinical Quality Management System (QMS) is resource intensive work that requires in-depth knowledge. By licensing or purchasing our clinical QMS you receive access to an ISO 14155-customized QMS which has been audited by an external auditor as well as EU and US based clients.
Post-Market Surveillance and Post-Market Performance Follow-up
The new In Vitro Diagnostics Regulation (IVDR 2017/746) places greater emphasis on PMS and PMPF. Whereof the latter shall be understood to be a continuous process that updates the performance evaluation and shall be addressed in the PMS plan. It is important to note, however, that the requirement for PMPF under the IVDR does not necessarily means that post-market clinical performance studies will be required in all cases to collect safety, performance and scientific data.
Kickfile’s system can be used for creating PMS and PMCF plans, reports and other necessary documentation as well as for updating your performance evaluation documentation.
Post-Market Surveillance and Post-Market Clinical Follow-up
The new Medical Device Regulation (MDR 2017/745) places greater emphasis on PMS and PMCF. Whereof the latter shall be understood to be a continuous process that updates the clinical evaluation and shall be addressed in the PMS plan. It is important to note, however, that the requirement for PMCF under the MDR does not necessarily means that clinical investigations will be required in all cases to collect clinical data. Under the MDR, the definition is much broader and related to all type of clinical information.
Kickfile’s system can be used for creating PMS and PMCF plans, reports and other necessary documentation as well as for updating your clinical evaluation documentation.
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