The Medical Devices Introductory Course 2020

Classification considerations and common arguments

What claims are made for the product ?

But, it only contains a small amount of drug”  No concept of “amount” of a medicinal substance in the medical device regulations  Inclusion must be justified and scientific data provided to support usefulness “ The drug is not intended to act” “The drug is only included to prevent bacterial contamination of the device” “We are including Human serum albumin rather than a bovine serum which is safer and how can that be a drug?”

Why would the product be used?

How does the product work?

What data is available (relative contribution of constituent parts to overall effects) ?

What are the precedents?

Presentation of product – how will it appear to the public ?

What does the literature say?

What does your website say?

The Organisation for Professionals in Regulatory Affairs

Guidance on Borderlines

Manual on Borderline Classification

There are differences in interpretations across the Community which can put public health at risk

To improve this situation and have a uniform approach there is a working party on borderline and classification that includes members from

 Commission Services

 Experts of Member States

 Other Stakeholders

Aim of group – provide a form to exchange opinions and reach consensus

Regular meetings held and publication of a Manual on borderline decision

https://ec.europa.eu/growth/sectors/medical-devices/current-directives/specific-areas- development_en

The Organisation for Professionals in Regulatory Affairs