Collection of clinical data in the conformity assessment for medical devices
The collection of clinical data is a critical aspect in the conformity assessment process of medical devices, and serves to substantiate a manufacturer’s claim regarding the safety, performance and benefit/risk ratio of a given device. Clinical data is generally understood as evidence on the safety and performance of a medical device based on actual usage of the device, and is typically derived from pre-clinical or clinical investigations, scientific literature and/or clinical experiences with similar devices.
Clinical evaluation report
The European Union (EU) requires manufacturers to conduct an evaluation of clinical data in connection with all medical device conformity assessments. These requirements are detailed in EU Directive 93/42/EEC as well as the latest revisions of EU Directives applicable to medical devices.
The clinical evaluation requires the manufacturer to take the following steps:
The clinical evaluation report must include all clinical evidence required to support medical device conformity assessments in the EU. Manufacturers of approved medical devices must also regularly update the clinical evaluation report in a pre-defined Modus to include data from actual post-approval experience of the device such as Post Market Vigilance Data.
Why choose TÜV SÜD
TÜV SÜD Product Service can conduct voluntary pre-assessments of manufacturers clinical evaluation reports. In addition, TÜV SÜD Product Service has a global staff of medical device experts, with over 400 international specialists located in major markets around the world. These specialists are supported by the in-house Clinical Centre of Excellence and the scientific advisory board that is under the standard TÜV SÜD confidentiality agreement. This board comprises well-recognized European scientists and physicians from the leading universities and healthcare centers.
Our services at a glance
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognized by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- Design dossier review and certification - As an EU-Notified Body, TÜV SÜD Product Service can review design dossiers for medical devices and issue design examination certificates in accordance with the EU’s Directives for medical devices.
- Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
- GLP - compliant biocompatibility evaluations - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
- Other testing and certification services - TÜV SÜD Product Service can conduct compliance testing for medical devices in accordance with other relevant regulations and standards.
- Training - TÜV SÜD Akademie offers seminars, webinars and general training courses addressing literature search for clinical evaluation, clinical evaluation report according to MEDDEV 2.7.1 rev. 3 as well as training for other technical and regulatory requirements applicable to medical devices.
Your benefits at a glance
- Recognized medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Centre of Excellence, TÜV SÜD Product Service is recognized by regulatory authorities around the world for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
- Expert partnership - TÜV SÜD Product Service has a long record of successfully providing outstanding technical and regulatory support to manufacturers of medical devices, and is a trusted partner to companies ranging from global manufacturers to regional and local research and development firms.