Before CE marking a conformity
assessment procedure must
successfully be accomplished.
Medical Devices
Before marketing a Medical Device in the European Economic Area (EEA) the manufacturer has to prove the device’s conformity with the requirements set out in the respective European Directives, thereby becoming entitled to label the product with the CE (European conformity) mark.
Our department “Special Medicinal Products, Medical Devices and Borderline Products” provides you with competent advice on the requirements for Medical Devices to comply with national and international legal regulations and guidelines. Our support spans from the initial identification of all relevant issues to successful CE marking and maintenance.
Classification of Medical Devices/borderline to other products
The purpose of a Medical Device, as to be defined by the applicant, determines which of the legal directives apply:
- 93/42/EEC Medical Device Directive (MDD)
- 90/385/EEC Active Implantable Medical Device Directive
- 98/79/EG In Vitro Diagnostics Directive
If the product is not an Active Implantable Medical Device, nor an In Vitro Diagnostic the classification of the device follows the rules described in Annex IX of the MDD. Thus the device will be grouped into one of four classes. In case of a Medical Device that includes as an integral part a substance which, if used separately, can be considered to be a Medicinal Product and which is liable to act on the human body with action ancillary to that of the device (“combination product”) it is automatically classified as a class III product and needs to undergo a consultation process on its way to CE marking.
Our advisory service covers the classification of your medical device, identification of the relevant directives, and the clarification of issues in cases where the product can be considered to be “on the borderline” to a Medicinal Product.
Writing the Technical Documentation
The Technical Documentation is one of the key elements for successful CE marking. It comprises topics like
- the description of the product
- the implementation of a risk management system
- a clinical evaluation and/or clinical trials, respectively
- the description of the manufacturing process
- the labelling and the instruction for use
together with other product specific information.
PharmaLex services include development of the outline and general design of the documentation, compilation of content and authoring of the Technical Documentation.
Clinical Evaluations and Clinical Trials
A further focus in the process lies on the Clinical Evaluation. Clinical evaluation means the medical-scientific risk-benefit evaluation of a medical device or its product family, based on clinical data with respect to efficiency and safety, including any adverse effects when used in compliance with the instructions for use. The result of the evaluation plays a major role for the further process, especially for the question if the product needs to also undergo clinical trials.
PharmaLex offers medical writing of clinical evaluation as well as clinical trial reports, including support for the applications for clinical trials to be submitted to National Competent Authorities and Ethics Committees.
Monitoring and preventing potential risks (risk management according ISO 14971)
Our expertise covers of course also the risk management according to ISO 14971. As such we can provide help detecting potential risks of the product, evaluating them and where applicable defining measures to eliminate or minimize any of these potential risks. We will be happy to describe in more detail all steps and lead you through the whole process upon request.
Quality assurance (Quality management according ISO 13485)
As mentioned above conformity of the product needs to be declared prior to distributing and selling it within the EEA. The preferred means to verify conformity is a certified quality management system according ISO 13485 by a Notified Body. The implementation of such a quality system, generation of the appropriate documentation and establishment of the relevant procedures can be done by or in close co-operation with our experts, including the advice on how to keep the system alive in the long run, and how to best benefit from it.
Surveillance and detection system of medical devices (Vigilance)
The requirements with respect to vigilance have been tightened significant within the last years. Manufacturers of medical devices and their representatives have to collect any known risks, evaluate them and need to co-ordinate the appropriate corrective actions. Most importantly, they are responsible to notify the competent authority within a certain time frame on any new risks that may appear during the usage of the device. The procedures and communication ways in case of such incidents and their corrective actions result from the Medical Device Safety Plan Regulation and the European Medical Device Vigilance Guideline MEDDEV 12/1.
Our experts can guide you through the process and give you advice about the relevant procedures, especially about the mandatory notification in electronic form to the BfArM or the ethic commission respectively, if needed on short notice. We can provide you with all necessary information, especially the surveillance requirements.
Our Service
On your way to CE marking PharmaLex would be happy to be your partner and guide you through the whole process. Our support covers all regulatory requirements. In addition to the topics mentioned above, we’re experienced communicators when it comes to contacting Notified Bodies and the National Competent Authorities (NCAs).
Our service covers Medical Devices of all classes, Active Implantable Medical Devices and In Vitro Diagnostics. It goes without saying that we also assist on short notice, especially in case of an incident and the subsequent notification requirements within tight time frames.
We look forward to hearing from you!