What is the EU Medical Device Directive?

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. Products conforming with the MD Directive must have a CE mark applied.

Who approves medical devices in Europe?

European Medicines Agency
The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain …

What is the latest Medical Device Directive?

Directive 93/42/EEC
The Medical Device Regulation (MDR) has entered into force on May 26th 2017. The MDR will replace the current EU’s Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

How are medical devices classified in Europe?

There are three main classifications for medical devices: Class I, Class II, and Class III. In addition, there are sub-classes such as, for example, Class IIb and Class IIa.

What are the already existing directives for medical devices in European Union?

Medical devices within the EU are currently regulated by 1 Regulation and 3 Directives:

• Regulation (EU) 2017/745 on medical devices (MDR)
• Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
• Council Directive 93/42/EEC on Medical Devices (MDD) (1993)

How do you classify a medical device?

In the U.S., medical devices are either Class I, Class II, or Class III. The FDA CDRH classification is based primarily on risk the medical device poses. Class I medical devices are generally deemed low risk and Class III medical devices are seen as the highest risk.

What is a Class III medical device?

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.

What are Class I II and III medical devices?

Class II devices are intermediate-risk devices. Examples include computed tomography (CT) scanners or infusion pumps for intravenous medications. Class III devices are high-risk devices that are very important to health or sustaining life. Examples include pacemakers and deep-brain stimulators.

What is a Class 1 medical device?

Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.

What is a medical device MHRA?

Text: Medical device means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which— (a) is intended by the manufacturer to be used for human beings for the purpose of- (i) diagnosis, prevention.

What is the difference between a Class 1 and Class 2 medical device?

Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls. Class III: A medical device with high risk that requires premarket approval.

What is the European medical device regulation?

EU Medical Device Regulation is the new regulation that makes its way after negotiations between the European Commission, European Parliament and the European Council. This Medical device regulation replaces the Medical device Directives (93/42/ EEC ) and the Active Implantable Devices Directive (90/385/EEC).

What is EU MDR compliance?

EU MDR Compliance. The EU- MDR establishes an equivalent to the Unique Device Identifier (UDI) system developed by the United States Food and Drug Administration (FDA). Companies whose products are distributed in the European Union must comply with the MDR.

What are the regulations for medical devices?

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device Listing, Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA), Investigational Device Exemption (IDE) for clinical studies.

What are FDA regulations for medical devices?

Medical Device Regulations in the USA. In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.