Clinical Evaluation is the assessment and analysis of data to appropriate to medical device to verify its clinical safety, efficacy and performance.
To achieve regulatory compliance and authorization for sale in Europe, every medical device needs to prove its safety, efficacy and performance must be supported by a Clinical Evaluation Report (CER).
This is not a new requirement for medical device manufacturer, but after the introduction of new Medical Device Regulation (MDR) introduced in May 2017 tightened requirements for CERs now there are more Post Marketing Clinical Follow-Ups (PMCF) studies and clinical data require for CERs, should be meticulously scrutinized.
Manufacturer must be able to comply all the requirements as per the MEDDEV 2.7/1 revision 4 June 2016. Otherwise they are having risk of removal of products from the market, due to reason of medical device not proof its safety, efficacy and performance claimed by manufactures.
Guidance for Writing of Medical Device:
Manufacturer should start writing of clinical evaluation is to collect, assimilate, and objectively present data about the medical device in accordance with the requirements of MEDDEV 2.7/1. This will require input from other experts, e.g. the manufacturer for technical information about the device, librarian or information scientist for literature searches, quality specialist for complaints data, and safety scientist for PMS & PMCF data.
The objective is to support conformity of the device with the essential requirements for safety and performance as per the European Medical Devices Directive (MDD) 2007/47/EC, to be superseded by the Medical Devices Regulation (MDR). It should be stated whether the CER is in support of initial CE-marking, a CE mark renewal, or is at the request of the Notified Body (NB). The documents required for all CERs and those additional documents specific to CE marked devices or to new devices, where equivalence with another devices is being claimed.
How you will get right data for Clinical Evaluation Reports?
It is important that manufacturer should know whether they have the right data available or not;
- How device is its intended purpose
- In which principle medical device is working
- All known and foreseeable risk, any adverse event, contraindication, are minimized acceptable when weighed against the benefits of the intended use
- That any claims made about the device’s performance and safety are supported by suitable evidence.
- Safety Precaution during use of device.
For products that are already on the market, companies should be conducting ongoing post-market surveillance to gather data on the real-world use of their devices; this identifies unforeseen risks, new contraindication, adverse event and complications, as well as areas for improvement. If they have been failing to do this, they will have to begin the time-consuming and costly process of collating data.
The roles of clinical evaluation and clinical investigation become far more prominent under the MDR, many requirements of MEDDEV and ISO 14155 are incorporated in MDR. New and tighter criteria are introduced for demonstrating equivalence. As a result, more clinical data must be obtained from clinical investigations of the device. Implantable and Class III devices generally require clinical investigations, unless a rationale can be provided for why this should not be the case. Manufacturers of implantable and Class III devices may consult an expert panel on a voluntary basis prior to the clinical evaluation. A manufacturer may rely on clinical data of another device if the new device is a modification of the old device, if the NB has confirmed this is only a modification, and if the manufacturer has full access to the technical documentation of the other device. The electronic system must also be used for PMCF studies. The design, execution, and requirements for documentation of a PMCF study have to meet many requirements applicable to clinical investigations.
Maven Profcon Services LLP is a medical device consultancy located At Ahmedabad India focused on medical devices. We have well qualified, dedicated and experience team for conducting medical device clinical studies as per the requirement of Europe. We also help to customers for PMS & PMCF studies, Data analysis, support to customers for conformity of the device with the essential requirements for safety and performance as per the European Medical Devices Directive (MDD) 2007/47/EC, to be superseded by the Medical Devices Regulation (MDR) are require for initial CE marking or a CE mark renewal.
- Preparation of CERs as per the requirement of MEDDEV 2.7/1 revision 4
- European Post Marketing Clinical Follow-up Studies for Medical Device
- Search & Analysis of Clinical Data
- Clinical Investigation as per ISO 14155 for Medical Device Clinical Studies
- Training on, how to prepare Clinical Evaluation Reports, what are data require for preparation of CER according to MEDDEV 2.7/1 revision 4.
- Gap Analysis of CER according to MEDDEV 2.7/1 revision 4