Medical Devices Regulations, Guidelines and Notified Bodies

MHRA

Devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, prior to the end of the transition period, gave effect in UK law to the directives listed below:

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
• Directive 93/42/EEC on medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

This means that the Great Britain route to market and UKCA marking requirements are based on the requirements derived from the above EU legislation.

EMA

Link to EMA Medical Devices pages.

The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. The priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation. Two new regulations on medical devices and in vitro diagnostic medical devices entered into force in May 2017. 

With effect from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices replaced Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices. With effect from 26 May 2022, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices replaced Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices.

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

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