Since the Medical Devices Regulation (MDR) 2017/745 entered in force and reached its date of application in May 2020, the MedTech industry has been extremely busy adapting processes, organisational flows and documentation to comply with the new requirements. This regulation obliged the industry to meet several goals. Among others:
- Having an appropriate quality system (QMS) in place
- Naming a person responsible for regulatory compliance (PRRC)
- Seeking the acknowledgment of sufficiency of clinical data by notified bodies and competent authorities
- Implementing clinical strategies for sufficient clinical data in the planning and reporting phases of a product’s lifetime
- Complying with new post market surveillance requirements in the form of Periodic safety update reports (PSURS) and summary of safety and clinical performance (SSCP)
The new Medical Devices Regulation requirements vary significantly depending on the device’s risk class. Being well informed is a must to ensure compliance of legacy products and to plan an appropriate strategy for new registrations in the pipeline. In this new regulatory environment, a clear understanding of the rules, an update on guidance documents and notified bodies activities, as well as the input from industry experience are key to support both, the infrastructure needed to obtain appropriate clinical evidence and the new clinical workload.
This second edition of the MedDev Day will shed light on the MDR rules after the date of its application with a clinical focus. We will share experiences and real-life examples from notified bodies, competent authorities, and industry on how to cope with regulations. The event will address topics such as:
- The EU perspective: Latest developments in MDR implementation regulations, Common Specifications and Guidance Documents with an impact on clinical data.
- The notified body perspective: Notified body experiences from stage one, audits on Medical Devices Quality Management System readiness, and MDR product certification. Expectations!
- Discussions on Common Specifications (CS) for MDR Annex XVI devices without medical purpose. Impact of CS on planning sufficient clinical data.
- The Role of the person responsible for regulatory compliance (PRRC) in the clinical strategy and investigational devices. Liability and risk mitigation.
- How to assess and close gaps in clinical evidence. Challenges in the clinical evaluation and investigation route. The role of post market surveillance clinical data.
- Practical Medical Devices clinical evaluation plans and clinical evaluation documentation per device risk class:
- Clinical evaluation plans and clinical development plans for class I, II and III products in line with the revised ISO 14155.
- Post market clinical follow up (PMCF) plans and reports for class I, II and III products.
- Post market surveillance (PMS) documentation, periodic safety update reports (PSURS) and summary of safety and performance characteristics (SSCP) how and what to compile for each device class.
- Combination products (Device-Drug / Drug-Device): Clinical aspects, Art 117 MDR consultation and guidance on quality requirements for drug-device combination products.
Laura Michellini - Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria
Who should attend?
For sponsorship opportunities, please contact email@example.com
21 September 2020
Half-day training on clinical evaluation reports (CERs) for combination products
Stay tuned for further details!
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Sede della Conferenza
Novotel Barcelona City
Avenida Diagonal 210 (entrada por Ciutat de Granada), 08018 Barcelona, Spain
Novotel Barcelona City hotel is located on one of the main streets (Avenida de la Diagonal) in the heart of Barcelona. With its cosmopolitan vibe and streets imbued with art thanks to the famous architect, Gaudí, Barcelona is one of Spain's best-known cities.
290 metres from Glòries metro station (Lines 1)
18 km from Barcelona-El Prat airport
In addition to the hotel venue, here is some recommended hotels for accommodation in the nearby:
- The Gates Hotel Diagonal Barcelona (at 70 mt)
- Hotel SB Glow (at 250 mt)
- Hotel Golden Tulip Barcelona (at 500 mt)
Nearby restaurants: El Racó de la Vila (at 900 mt.)
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 networking lunch will provide a pleasant moment of refreshment and an opportunity for you to network with your industry peers. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
All our conference facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the conference. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click.
All the necessary information for the Conference is provided. The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance.