All times indicated on the Agenda are Central Europe Summer Time.
At the end of the Conference you can enjoy a relaxing moment with a Singing Live Entertainment!
Since the Medical Devices Regulation 2017/745 (MDR) entered into force, the MedTech industry has been busy adapting processes, organisational flows and documentation to comply with the new requirements. After the MDR compliance date being postponed by 12 months until May 2021 to respond to COVID-19 limitations, the MedTech industry still needs to focus on managing the final steps of the transition period to align strategies within this new challenging environment. The regulation obliges the industry to meet several goals. Among others:
- Having an MDR compliant quality system (QMS) in place within the context of remote audit implementation
- Defining the organisation of a person responsible for regulatory compliance (PRRC)
- Seeking the acknowledgment of sufficiency of clinical data by notified bodies and competent authorities while managing clinical trials
- Implementing clinical strategies to meet the requirements of the MDR as regards to clinical development, equivalency approach, sufficiency of clinical data for legacy devices and post market clinical follow up plans and reports
- 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 CE markings in the pipeline. In this 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 a few months before 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 Clinical Guidance Documents
- The notified body perspective: Notified body experiences on audits on Medical Devices Quality Management System readiness, and MDR product certification. Lessons learned from past audits including remote audit situation
- The Industry perspective: how to use the remaining months for MDR readiness and MDD projects
- 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 investigation 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.
The second edition of the MedDev Day will be a one day fully virtual meeting and will bring together quality, regulatory and clinical expertise from Medical Devices and Pharma industry, CROs, Regulatory Authorities and Academia.
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?
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22 September 2020
Abstract available soon
The coming into force of the new regulation offers opportunities to further document the design and development of the devices. In this section we will talk about the expectation for Technical documentation sampling, rounds of questions, post market clinical data. The postponing of the Date of application gives one year more for manufacturers to either renew MDD/AIMDD certificates and to apply for MDR. Concomitant validity of both MDD/AIMDD certificates and MDR certificates on the same product pose other challenging with respect to manufacturing and post market data we will also discuss in the session.
This session will provide an overview of the ongoing implementation of Medical Devices Regulation (MDR) from a notified body perspective.
This presentation will examine the MED-EL experience and learnings on the various parts of this challenging journey:
- Internal MDR project set up: a breakdown of the phases of the project, governance, responsibilities and changes over the project lifetime;
- Getting QMS system MDR ready: the process to identify gaps in our system and remediate gaps in preparation for the external notified body audit and tips for a successful audit;
- Notified body MDR review and learnings: preparation of the technical documentation for Notified Body review, differences in the different classes, tricky GSPR requirements, sample review questions, challenges and solutions;
- Transitioning fully to MDR challenges: braving the next frontier of balancing the requirements of both MDD/AIMD and MDR products until 2024/2025.
Aim of presentation will be provide our MDR project, audit and product review learnings and to share tips and advice on how we navigated certain challenges along the way.
The growing use of devices that do not have a specific purpose in the medical field but that are used both in the professional and private sectors, has pushed the European legislator to insert them in the EU Reg. 745/2017 (MDR) to protect not only the public health but also manufacturers and end users. These devices are specifically identified in Annex XVI of the MDR Regulation and among these are predominant those used in the aesthetic field, such as coloured contact lenses, fillers or other skin injectables (except those used for tattoos), equipment used for liposuction, lipolysis or lipoplasty.
The manufacturers of devices for aesthetic use, having to fulfil these new obligations, shall start planning an adequate Quality Management System and prepare the Technical Documentation required by the MDR Regulation and adhere to the requirements that will be described within the Common Specifications (CSs).
The new Medical Devices Regulation 2017/745 (MDR) requires manufacturers to appoint a "person responsible for regulatory compliance" (PRRC). Requiring a PRRC is a new legal requirement under the European Union medical device rules and there are many open questions around this new function. The PRRC will have a very broad range of regulatory responsibilities. Effectively, this person will need to oversee and have responsibilities related to almost all regulatory affairs activities in the pre-market and post-market stage of the life-cycle of the medical device, including investigational devices.
Even though the PRRC is assigned with these important responsibilities, the MDR is rather silent on the question whether and when the PRRC may be personally liable for these activities and any damages resulting therefrom. This presentation will discuss the legal framework of the liability rules that apply to the PRRC and to the medical device manufacturer and will aim to delineate the scenarios when the device manufacturer is liable and when the PRRC may be held liable under civil and criminal laws. The presentation will also discuss practical measures and steps that PRRCs and device manufacturers may take to mitigate their liability risks in the daily business practice.
Regulation 2017/745 (MDR) puts a much stronger emphasis on Post Market Surveillance compared to the current MDD. We will discuss the PMS plan as central document in the device life cycle, its content and how the data gathered through PMS activities will be reported. A link between the risk management file and trend reporting as outlined in Article 88 of the MDR will be established. The Periodic Safety Update Report (PSUR) for device classes IIa, IIb and III will be discussed in more detail, incl. the use of IMDRF codes for more uniform reporting.
Regulation 2017/745 (MDR) and 2017/746 (IVDR) were released with a clear desire to place patients and users of medical device at the center of device development and post-market surveillance. With a strong focus on safety and proactive risk management, the new regulations take device vigilance requirements from guidance into law and will certainly lead to higher oversight by Competent Authorities and Notified Bodies. Companies need to prepare for higher scrutiny without the support of guidance and facing much uncertainty on elements newly introduced by the MDR / IVDR text. While the recent delay in the MDR date of application will allow manufacturers to benefit from additional time to prepare, there is substantial work required and early and proactive readiness will help secure the product portfolio. This presentation shares the lessons learned on preparatory work and certification audit experience for the first successful medical device certificate under Regulation 2017/745 in 2019.
managed by Melania Battistella, Global Manager Aesthetic Products at TUV SUD
The lecture will be followed by an interactive section.
MedDev Day Virtual
Virtual conference with presentations, slots for Q&A and discussion among delegates.
LS Academy will provide the link to join the conference some days before the conference date.
All times indicated on the Agenda are Central Europe Summer Time.
Fee includes: access to the virtual conference, organizational support, certificate of attendance, slide presentations in pdf format provided post-event.