MARKET INTRODUCTION OF THE MEDICAL DEVICE
For the purposes of a correct market introduction of the Medical Device, it is the Manufacturer is responsible for:
- Classifying the Medical Device. Classification is based on the intended use of the product. Regulation 2017/745 sets out that Medical Devices can be divided into four classes: I, IIa, IIb and III, depending on their complexity and the potential risk for patients, users or other persons.
- Demonstrating the compliance of the Medical Device with Regulation (EU) 2017/745 Requirements. To demonstrate the product conformity with the General Safety and Performance Requirements, the Manufacturer shall prepare appropriate technical and clinical documentation, describing the Medical Device and the related design, manufacture, marketing and post-market surveillance processes.
- Guaranteeing and CE marking the Medical Device. For Medical Devices having a class higher than I and for some aspects concerning class I devices (sterility, measuring function or reusability), the Manufacturer, before attesting product conformity, shall start an assessment of conformity procedure for the Device with the support of an independent third party, the Notified Body. For most Medical Device in Class I statement of conformity is carried out by the Manufacturer, by issuing the Declaration of Conformity.
MEDICAL DEVICE TECHNICAL DOCUMENTATION
The Medical Device Technical documentation consists of all the documents prepared by the Manufacturer, regardless of any partial or total outsourcing of the design and/or production, to demonstrate the compliance of the Medical Device with Regulation 2017/745 requirements. The technical documentation also include clinical evaluation to demonstrate the efficacy and safety of the medical device.
Certiquality provides courses that cover various subjects, such as:
- Regulation (EU) 2017/745 of 5 April 2017;
- Person responsible for the implementation of Regulation (EU) 2017/745;
- Risk management on the manufacturing process of medical devices in accordance with the ISO 14971 standard;
- Training on ISO 13485 standard (Quality System for Medical Devices);
- Design and validation of substance-based Medical Devices.