Please note the course date is now November, not October as previously advertised

 How to Register

Course Overview

This Course is provided to give product designers and developers an understanding of the underlying principles of medical device regulations and their requirements for medical device design and to then apply these requirements when identifying plastics materials that are suitable for use with medical devices. A detailed over view of the EU Medical Device Directive 93/42/EEC is given and the technicalities of its compliance explained. The use of polymers in medical devices is considered in terms of design and material selection. The course modules also focus on material testing requirements and look to the developments in ISO 10993 Biological Evaluation of Medical Devices where new standards are provided which allow alternatives to traditional animal testing.

Who Will Benefit?

This course is intended for technical, design, research or engineering personnel who conduct, or have responsibility for, the design and material selection for medical devices and/or have responsibility or input into Medical Device CE marking.

This course is equally applicable to Regulatory and Quality personnel who have a responsibility for product regulatory submissions and require an understanding of the technical aspects of material selection and proof of function and safety.

Course Content

History and Overview of the EU Medical Devices Directive (MDD)

An introduction to the European New Approach Directives and a brief history of the Healthcare and specifically the Medical Devices Directive introduction.

Structure of the MDD, Key Annexes and Articles

A description of the 3 main sectors within the Directive, explaining differences and relation between Recitals, Articles and Annexes, and how Conformity Assessment can be achieved for a device depending upon its intended use. The Conformity Assessment process will introduce the requirements for Technical Aspects of the device.

Annex 1 – Essential Requirements

A review of all the Essential Requirements – Annex I – which may be applicable to the medical device, and how the Essential Requirements can be used as a designers checklist.

Material Specific Essential Requirements

A focus of a selection of the Essential Requirements which are specifically aimed at medical device material selection, proof of function and proof of safety when used in contact with a patient.

Classification and Conformity Assessment

Describes the rules for classifying medical devices, which can significantly affect the amount of design work required in respect of the product. The Conformity Assessment Route results from the device classification and impacts on the amount of data, including design data, which has to be provided to and reviewed by the Notified Body for certification and ultimately CE Marking.

Plastics in medical device design

An overview of the main plastics materials types and their properties and how these are affected by:

the structural design of the device the required duration of the device

the chemical resistance issues associated with its intended use.

Sterilization methods

Solvent bonding of like and dissimilar plastics and the toxicological issues associated with this.

Assembly of Medical Devices 

A review of modern assembly techniques that are suitable in the design of medical devices. Emphasis is given to minimizing part count and reducing assembly costs.

Sterilization and Material Selection

Matching a plastic medical device to a suitable sterilization technique is important to ensure the long term durability of the device. The influence of different sterilization techniques on plastics is explored and the implications explained for material selection.

Structure and Key Clauses of ISO 14971 – Medical Devices Risk Management

A detailed review of the updated standard – ISO 14971 – Medical Device Risk Management – and how Risk Management is a key aspect of both the Technical Review by the Regulatory Authorities and Quality System.

Key steps in conducting risk analysis

 A detailed insight into the structure of the risk management standard, how to conduct a risk analysis and how risk management should be conducted throughout the lifetime of the device.

Assessing Toxicological Risk - Introduction to Biological Evaluation of Medical Devices –

ISO 10993-1 & US FDA requirements

An overview of the recognized standards for biological evaluation of medical devices – ISO 10993 – demonstrating how the standards should be used, and also highlighting differences between EU and US requirements.

Harmonized Standards

An understanding of the Technical Standards that have been developed to assist Medical Device Designers to demonstrate compliance to the medical device directives, and provide an understanding of the hierarchy of the standards which should be considered.

ISO 10993 part 18 and its part in the process of materials selection

How to use chemical analysis to establish biological safety data.

Technical Documentation Compilation

A summary of how to compile all the Technical Documentation / Design Dossier into a format that will be expected by the Regulatory Authorities for review and approval.

Course Objectives

To enable delegates to apply the requirements of medical device regulation to plastics materials selection.

Course Presenters

Tom Donnelly – Medicom Consulting