RGA6221:

European Compliance Process & Regulatory

Affairs

Week 2

Instructor: Yulia Perlman

The EU Medical Device Legal System

Overview of EU Authorization procedures
for Medical Devices
 This week you will have the opportunity to:

• Describe legal requirements for medical devices

• Define three Main Medical Device Directives
• Define the principles of Conformity Assessments
• Compare and contrast the role of the Competent Authority and Notified Body
• Define relationships between the key stakeholders
Background
“A child is not a small adult”
• Clinical trials in children are more difficult, take longer and cost more; said to be
unethical
• Children require specific formulations
• Paediatric indications are not profitable
• Liability of use in children
Studies of medicinal products are performed by industry mostly in young
adults, but not in children
 Regulatory Organizations in Europe

The main organization involved in the medical device regulatory process

in Europe are:

1. European Commission
2. Competent Authority
3. Notified Body
4. European Union Authorized Representative
5. Manufacturer
 European Commission

• Consists of representatives from each European Union Member State and

headed by a President

• Responsible for the formal and practical implementation of the various treaties
of the Union and the various rules issued by the Council of ministers

• Helps prepare acts submitted to the European Parliament and the council of
Ministers

• Enforces the laws of the EU, acts to ensure the integrity of Europe's integrated
market, and administers the agricultural policies and regional development
programs in the EU
 Competent Authority
A Competent Authority is responsible:

• For effective implementation of the Directives

• Implementing provisions for clinical evaluation approval

• Implementing provisions for processing post-production data from

manufacturers

• Selecting and appointing suitable third parties to perform conformity

assessments

• Taking action to safeguard public health from devices that pose or could
pose, unacceptable harm
 European Union Authorized Representative
An Authorized Representative will be engaged in one or more of the
following activities:

• Completing a company’s compliance route for establishing an impartial,

independent, European presence for all devices

• Representing a company’s route for registering Class I) non-sterile and/or non-

measuring) devices manufactured within the EU (if the company is based
outside the EU)

• Serving as a company’s interface for communicating complaints and other

notifications to the appropriate Competent Authorities for all devices classes

• Responding to the compliance enforcement communication and instructions by

the Competent Authorities
 Manufacturer
The manufacturer (or the person placing the product on the market) is
responsible for:

• Defining the intended purpose of the devices

• Obtaining the appropriate assessment certificates as per the selected
Conformity Assessment Procedure
• Selecting the relevant technical standards to be used to demonstrate
conformity, creating, updating and retaining technical documentation at the
disposal of the Competent Authorities
• Implementing and operating a post-market vigilance system to inform the
competent Authorities of notifiable incidents
• Insuring that the device conforms to the relevant Essential Requirements
• Making a written declaration that the device conforms to the requirements of
the Directive
• Affixing the CE mark on the device
 Basic steps for Obtaining a CE Mark
• Classify your device
• Select an appropriate Conformity Procedure
• Appoint a NB (if appropriate)
• Demonstrate Conformity with the relevant Essential Requirements
• Use appropriate standards
• Perform a risk assessment or hazard evaluation
• Produce the appropriate technical documentation
• Make a written Declaration of Conformity
• Apply the CE Mark