From MDD to MDR: Full Training Suite Package

Opportunity
The First session will be a Masterclass from MDR expert Prof. Dr. Frank Stein on the latest news and Updates regarding the EU-MDR.

Certificate
You will receive an certificate of participation.

Virtual Class Days

Introduction

The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.  All manufacturers of Class I to III medical products must familiarize themselves with the new requirements as soon as possible. The regulation has far-reaching implications and affects all classes of medical products.

WCS has designed a 12-session virtual training program to assist manufacturers at every stage & step of implementation. You will get trained on the EU-MDR to align your company with the new requirements of the Medical Device Regulation (EU-MDR).

The different sessions will present participating organizations the opportunity to prepare their subject matter experts, thus, employees will be trained on the implementation process in their specific area of expertise.

Training Includes : Full package of 12 sessions duration of 16 hrs .

 8th April 2021 

 14th April 2021 

 19th April 2021 

 23rd April 2021

 28th April

Who should attend?

The program includes exclusive content developed by WCS Faculty and is suitable for professionals at any level of knowledge (beginner to advanced professional) e.g. quality & regulatory affairs specialist and manager.

Medical device manufacturers, especially if your role is in:

Training #1

Introduction:

The Latest News and Updates will offer the Medtech Industry insights and experiences from WCS expert Prof. Dr. Frank Stein. It is designed to provide insights in the steps for efficient transition to the new European Medical Device Regulation. The program includes especially focused and latest content developed by WCS experts and is suitable for professionals at any level of knowledge (beginner to advanced professional).It allows a direct interaction with our expert who provide trainings at a Notified Body and Industry and have hands on experience worked on multiple projects from start-ups to large multinationals.

This first session will summarise the key changes in the transition from the MDD to the new MDR. 

The Medical Devices Regulation (MDR) is the legislation setting out the requirements that manufacturers must meet in order to market medical devices in the European Union. It affects all manufacturers, importers, distributors and representatives of medical devices within the EU. The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). 

Who should attend?

Manufacturers of medical devices, especially: Regulatory Affairs, Clinical Affairs Specialists and Quality Assurance specialists. 

During the course new and changed key-concepts and requirements of the QMS discussed, reviewed and comparisons to business processes are made. As we read the MDR carefully, we will learn that there are several processes that need to be addressed in the QMS. This training is also intended to cover the areas that are not very obvious in the MDR, yet very crucial that manufacturers account for them in the QMS for MDR readiness.

Learning Objectives:

Who should attend?

Quality Assurance Managers, Internal auditors, anyone involved in the implementation and maintenance of a Quality Management System in the Medical Device Industry.

Introduction:

The MDR and IVDR require that manufacturers and Authorized representatives have a person responsible for regulatory compliance. Article 15 of the MDR/IVDR determines the expertise and responsibilities. These have been further clarified in the recent guidance document MDCG 2019-07.

Learning objectives:

MDR Suite #5: Technical Documentation

The EU-MDR introduces a new view on technical documentation, that is broader than the current view on technical files and design dossiers. It differentiates between data needed prior to market access (MDR annex II) and post-market data (annex III). With all the changes one can only conclude that all technical files and design dossiers need to be to match the EU-MDR requirements.

MDR Suite #6: EUDAMED & UDI

Introduction

Device identification and traceability system based on UDI and submission of comprehensive product information to EUDAMED are two major additions in the MDR and IVDR. The regulatory requirements for UDI aim to ensure positive identification of a medical device, improve accuracy and completeness of adverse event reporting, enhance management of recalls, eliminate use of counterfeit products and reduce medical errors.

Implementation of UDI and adoption of EUDAMED will require substantial investments by healthcare stakeholders. Solutions need to account for capabilities of producing compliant coding symbiology and barcode scanning to auto-capture the information. IT systems must allow for UDI information to be shared, maintained and utilized for electronic patient records, adverse event reporting, product recalls and other applications related identification and traceability.

MDR Suite #7: Risk Management 

 Introduction:

Attendees are introduced in the basic principles of a systematic approach of risk management together with the updates of the standard. This session describes the life cycle context that the risk management process will operate in. It includes addressing the pitfalls of poor and incomplete risk management and the consequences for associated processes as clinical evaluation and Post Market Surveillance.

MDR Suite #8: Economic Operator

All current and upcoming Union legislation is based on this New Approach. So too is the Medical Device Regulation (MDR) which entered into force on 25 May 2017. In comparison with the Directive, this Regulation supersedes, it contains a completely new chapter on economic operators and their obligations. The term “economic operator” encompasses manufacturers, authorized representatives, importers, distributors and the persons referred to in Article 22(1) and 22(3) of the MDR. All these individual economic operator figures now have specific legal obligations they have to comply with: distributors now have to verify whether the manufacturer they distribute products for complied with its obligations, authorized representatives now have to have a written mandate in place that divides responsibilities between them and their manufacturers and so on and so forth. Manufacturers will now have to tightly control their downstream supply chain as, for example, a non-complying distributor might potentially, when caught in the act by a Competent Authority, lead to a withdrawal or in severe cases administrative fines or sanctions.

However, most of the economic operator obligations have already been in place since the EU New Legislative Framework was adopted in 2008. So while it might be a newly included chapter in the MDR, most of the aforementioned has already been soft law since 2008 to the shock of most people. Reason enough to start implementing these changes as soon as you can.

Who should attend this course?

Employees of medical device manufacturers, importers, distributors or European Representatives who are involved with regulatory aspects of the supply chain.

Agenda:

1. Compliance in the operational environment 

     Legal framework and terminology

     Outsourced manufacturing processes

     Sales under own brand - future of OEM / “Virtual M” cooperation under the MDR

     Own brand labelling

     Liability implications

2. Contractual regulation of outsources manufacturing processes

      Essential regulatory content from a regulatory perspective

      Avoid pitfalls and liability risks

Learning Objectives:

Delegates will learn about the implications of MDR principles and requirements on existing and future relationship between physical manufacturers and legal manufacturers. This includes the cooperation between original manufactures and companies which intend to place medical devices on the European market in their own name or under their own brand. We will look at liability risks and options to address them in contractual agreements.

Introduction:

The EU-MDR introduces an updated view upon the MDD’s essential requirements and transposed them into completely updated General Safety and Performance Requirements (GSPR). The extended and more detailed requirements require more extended and detailed evidence documentation for providing compliance with the GSPR.

MDR Suite #11: Clinical Evaluation

Manufacturers struggle to address requirements for clinical evaluation for all classes of devices, with many erroneously assuming class I devices will not need clinical data. Clinical evaluation is required for all medical devices regardless of risk classification or clinical data requirements. While the ideology of evaluating clinical evidence to demonstrate compliance with relevant General Safety and Performance Requirements remains unchanged, the medical device regulation (MDR) 2017/745 along with the recently published MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence and MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices includes stringent requirements for acceptable clinical data, demonstrating equivalence to a marketed device, and the ability to establish conformity for devices in which clinical data is not deemed necessary (Article 61 section 10).

MDR Suite #12: PMS & PMCF

Post Market Surveillance (PMS) and its subset of Post Market Clinical Follow-up (PMCF) increasingly become part of the regulatory lifecycle thinking of modern medical device regulations. Moving away from the historic one-time review on compliance prior to market access to frequently review, PMS needs to be set up as a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality.

Post-market surveillance requirements are in direct relation to risks associated with the device based on its intended use, such as the product or technology being new to the manufacturer and the extent of the available scientific knowledge and market experience with similar products.  Actual product-specific plans for gathering post-production data about your product or product family need to be set up for the lifetime of the device.

Regulatory bodies across the globe are imposing increasingly demanding and prescriptive requirements for post-market surveillance. In particular, regulatory bodies are establishing specific requirements for more proactive post market surveillance mechanisms, rather than relying simply on reactive systems, such as complaints monitoring.

PMS: 

PMCF

Prof. Dr. Frank Stein

Lead Auditor - Tutor - Speaker - QM - RA - Medical Devices / SaMD / MDSW - MDR - MDSAP - ISMS - TISAX

Dr. H.C. Frank Stein, Medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.