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Implementation of the 2017/745 MDR by Notified Bodies: Weaknesses of the Technical Documentation

Insights of the MDR and most relevant issues identified by Notified Bodies during the evaluation process 

Date

25 June 2020

Location

Milan

Language

Italian

Implementation of the 2017/745 MDR by Notified Bodies: Weaknesses of the Technical Documentation

The new Medical Devices Regulation (MDR) 2017/745 presents different variables for manufacturers, who now need to implement important changes to the current technical dossiers.
The main aspects to focus on will be:

  • Usability of the products
  • Reviewing the Risk Analysis in relation to Usability 
  • Post-Market Surveillance set-up
  • The new checklist of the General Safety and Performance Requirements which replaces the current Essential Requirements

Manufacturers will also need to present the production process and the raw materials used and to implement changes to the product labeling in detail.
In the past few months, notified bodies have started to analyze the technical documentation prepared by manufacturers. As a consequence, they have provided important indications on what the weak points are and what level of precision is needed to comply with the MDR regulation.
In addition, the new Corrigendum of November 2019 translated into a change of planning and timelines for many manufacturers, which led to a re-evaluation of the deadlines for carrying out the needed activities.

    • Regulations and guidelines, the different sections of the Technical File of medical devices: brief introduction
    • News brought by the European Regulation MDR 2017/745
    • Notified Bodies and types of conformity to Essential Requirements under MDR
    • The importance of planning your own personalized Action Plan (exercise)
    • Usability: what has changed after the MDR?
    • Usability: the Notified Bodies approach (case study)
    • Post-Market Surveillance: structure and content
    • Post-Market Surveillance: Notified Bodies approach (case study)
    • Production process: details requested under the MDR by Notified Bodies
    • Clinical Evaluation: what has changed with the new Regulation?
    • Clinical Evaluation: Notified Bodies approach (case study)
    • UDI and Eudamed: obligations and timelines for implementation
    • Regulatory Assessment, Labelling and other changes introduced by the new MDR
    • How to manage updates and changes

    Course Language

    The course will be in Italian.

    Giovanni De Paolini
    Giovanni De Paolini Medical Device Regulatory Consultant

    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.

    Regulatory Affairs Specialist/Officer, Regulatory Affairs Manager, Design Assurance Engineer.


    Participant experience:

    The course is designed for those who have a basic understanding of the needed requirements for a CE mark, but who which to learn more on the new changes under the MDR.

    Presentations, practical examples, case-study discussions.

    Hotel Melià
    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.


    Upon Arrival
    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.

    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.



    Training Room

    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.



    Teaching materials

    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.

    Fee includes
    Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

    The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
    Brochure
    Certificate of attendance

    Early Bird: € 790,00* (until 04 June 2020)

    Ordinary: € 905,00*

    Freelance - Academy - Public Administration**: € 485,00*


    * 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.


    Register now

    Course Price

    905.00 €

    Early Bird

    Thursday, June 4, 2020

    790.00 €

    Payments accepted

    • Bank Transfer
    • Credit Card
    • PayPal

    Other Details

    Duration

    1 day

    Course Type

    Limited number of partecipants

    You will receive

    Certificate of attendance

    At the end of the training, you will be able to

    • Implement changes under the MDR

    • Appropriately plan the implementation of actions needed to create a technical file under the MDR

    • Know and face problems and weaknesses of the Technical Documentation

    • Actively participate in the list of deliverables during the development production process

    • Actively coordinate the different functions involved in the creation of the needed documentation to put in place the technical file

    • Get to know the news brought in by the November 2019 corrigendum to the 2017/745 MDR

    Participants' Feedbacks

    Availability and competence of the lecturer

    In each topic there was some relevance to my daily work

    Only positive: very expert presenters in this field, very good discussion at high level

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    Implementation of the 2017/745 MDR by Notified Bodies: Weaknesses of the Technical Documentation

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    The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
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