Discover the course
Clinical Evaluation and Investigation of Medical Devices
A new approach following the European Regulation MDR 2017/745
The collection of clinical data in view of a Clinical Evaluation Report and its periodic update have become more and more important. The publication of the MedDev 2.7.1 Rev.4 and, even more, the new European Regulation (MDR) 2017/745 compel medical device manufactures to review the methodology in use for their Clinical Evaluation Reports and to present clinical data even for devices that would otherwise be evaluated according to data in the literature.
The conduction of clinical studies is essential prior to placing a device on the market that is innovative or of a high risk class. It is also essential for devices that have been on the market for long, but that do not have systematically collected clinical data.
In this context, Notified Bodies have become more demanding in defining the criteria for accepting clinical evidence, especially for medical devices with high risk for patients.
In order to comply with the requirements contained in the Directive and in the Regulations, manufacturers need to prepare a clinical validation plan for their products that does not only rely on the collection of available bibliography, but that also provide for the collection of clinical data through clinical studies, clinical investigations and pre- and post-market trials.
- The impact of the new European Regulation (MDR) 2017/745 on the world of medical devices
- The impact of the new European Regulation (MDR) 2017/745 on the world of clinical studies with medical devices
- The MedDev 2.7.1 and the MDR. State-of-the-art in terms of Clinical Evaluation
- The Clinical Evaluation: general structure of a Medical Device Clinical Evaluation Report
- Equivalence and access to data
- The Notified Bodies perspective: expectations, requests and case studies
- Indications, Contraindications, Warnings, Precautions and other outputs of the Clinical Evaluation
- Conformity of essential Requirements with clinical data to be evaluated: what has changed in the MDR as compared to the MDD?
- Evaluation of data in the literature: Medical Devices Clinical Evaluation or Clinical Investigation?
- Clinical studies with medical devices: ISO 14155 and ISO DIS updates
- Clinical studies with medical devices:
- Post-market and clinical follow-up studies
- Who is involved?
- Needed documentation
- Authorization procedures
- Clinical study management
- MDR news on the topic
The course will be in Italian
He graduated in Chemistry and Pharmaceutical Technology in 2004. Thereafter, he gained extensive experience in the Regulatory Affairs field in various multinational companies, spanning from cosmetics, to biocides, and food supplements. Since 2007 in particular, he has often worked in the field of medical devices.
Presently helping clients as a freelancer, he actively collaborates with many different international companies and helps these to obtain CE marking in the EU and Market Access in Italy. He is also involved in registration of medical devices in the United States and all around the world.
Graduated in Chemistry and Pharmaceutical Technologies at the University of Genoa, she has more than twenty years of experience in the field of CROs. She has worked as Project Manager for numerous clinical projects for the most important pharmaceutical companies and for Health Institutions. After having held the role of Clinical Operation Manager at a CRO for some years, Laura is now the Scientific Director of Latis Srl and of Elle Research Srl, two CROs that deal with the design and conduct of pre and post-market clinical studies with medical devices, supporting manufacturer in the acquisition of clinical data on their products.
This training course is aimed at medical device manufacturers, companies and CROs who intend to support manufacturers in the clinical development of medical devices, and in particular to project managers, product managers, quality managers, CEOs, medical & scientific managers, regulatory affairs.
Basic knowledge of clinical research.
Via Masaccio 19
20149 – Milano
Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.
2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)
Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train
Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km
Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Hotel Oro Blu (at 230 mt)
Hotel Portello (at 450 mt)
Hotel Montebianco (at 270 mt)
Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 1.535,00* (until 05 May 2020)
Ordinary: € 1.755,00*
Freelance - Academy - Public Administration**: € 810,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Tuesday, May 5, 2020
At the end of the training, you will be able to
Know the applicable regulations
Understand when a pre- or post-market clinical investigation is needed for a new device or for a device already on the market
Set-up a clinical investigation
Evaluate the opportunity that translates from the conduction of a post-market clinical study
Complete the technical file section related to the clinical evaluation according to the new guidelines and keep it up to date