Medical Devices Regulations, Guidelines and Notified Bodies

Medical Devices: Deal reached on new EU rules

On 25 May 2016, the EU agreed new rules on medical devices and in vitro diagnostic medical devices. 

The agreed two draft regulations are expected to achieve a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner.

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Medical Device Directives

For the most recent version of these and other directives related to medical device research click here.

A directive is a legislative act of the European Union that requires Member States to achieve a particular result without dictating the means of achieving that result. When adopted, directives give member states a timetable for the implementation of the intended outcome into national law.

Commonly used directives are:

• 93/42/EEC
  Medical device directive
• 90/385/EEC
  Active implantable medical device directive
• 98/79/EC
  In vitro diagnostics directive

MEDDEV Guidelines

MEDDEV guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health. They have been carefully drafted through a process of consultation with representatives of Competent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the medical devices sector. The guidelines are not legally binding, but due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions.

Examples of MEDDEV guidelines are:

• MEDDEV 2.4/1
  Classification of medical devices
• MEDDEV 2.7/1
  Clinical evaluation: Guide for manufacturers and notified bodies
• MEDDEV 2.7/3
  Clinical investigations: serious adverse event reporting
• MEDDEV 2.12/1
  Medical devices vigilance system

For the most recent version of these and other MEDDEV guidelines related to  medical device research click here.

ISO Standards

ISO standards are copyrighted and ISO charges for copies of most standards. You can order ISO standards here.

An ISO standard is a normative document that provides a set of rules to be consistently used as good principles, practices or guidelines. A standard controls how people develop and manage materials, products, services, technologies, processes and systems. ISO standards are developed by a technical committee involving stakeholders from industry, science, academia, consumer and governments and supported worldwide.

Examples of commonly used ISO standards in medical device research are:

• ISO 13485
  Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 14155
  Clinical investigation of medical devices for human subjects - Good clinical practice
• ISO 14971
  Medical devices - Application of risk management to medical devices
• ISO 17025
  General requirements for the competence of testing and calibration laboratories

Non-European Regulations

Outside Europe, other regulations apply. Links to regulations in common non-European countries where medical device research is done, can be found below.

Canada
Health Canada Medical Devices Homepage

United States of America
FDA Medical Devices Homepage

Japan
PMDA Ministerial Ordinance

India
CDSCO Medical Devices division

Australia
TGA Medical Devices & IVD homepage

New Zealand
MedSafe Regulatory Homepage for medicines and medical devices