What is European Medical Device Regulation?

What is European Medical Device Regulation?

The European Medical Device Regulation (EU MDR) is intended to ensure a high standard of quality and safety for medical devices being produced in or supplied into the European Single Market.

What are international standards for medical devices?

ISO 13485, which is the standard for medical device quality management systems. ISO 13485:2016 is the most current version, and it’s also harmonized in Europe. ISO 14971, which is the standard for medical device risk management. The most current version is ISO 14971:2019, but it isn’t yet harmonized in Europe.

What is the highest classification of a medical device in EU?

Class III – this classification is for the highest risk medical devices and requires a conformity assessment.

What are the new EU MDR requirements?

The new MDR includes a mandate for Unique Device Identification (UDI) that is intended to facilitate the traceability of all medical devices sold in the region. Devices must be marked with a device identifier (DI) and each batch or production series of the product will be marked with a production identifier (PI).

What IEC 82304?

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers.

What is a Class 1 medical device UK?

Medical devices are divided into four classes in the UK, in accordance with the UK Medical Device Regulations 2002,generally based on the intended purpose of the device, how long it’s intended to be used and how invasive it is: Class I: low-risk devices like wheelchairs or stethoscopes.

What is the European equivalent of FDA?

European Medicines Agency (EMA)
European Medicines Agency (EMA) : The European Medicines Agency (EMA) is a decentralised body of the European Union, located in Amsterdam. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

What IEC 80001?

IEC 80001-1:2010 applies to responsible organizations, medical device manufacturers and providers of other information technology for the purpose of risk management of an IT-network incorporating medical devices as specified by the responsible organization.

What is the latest version of IEC 62304?

The second version of IEC 62304 is still in draft. It has been in this state for five years, since the publication of the amendment 1. We already had a draft version in 2019. A new draft version is, again, in public review (or has been in public review in your country) under the name IEC CDV 62304:2021.