Is 93 42 EEC still valid?

Regulatory requirements for medical devices From May 26, 2021, the EU Medical Device Regulation, (MDR (EU) 2017/745) has replaced the EU's Medical Device Directive (93/42/EEC). … Click here for more information about the Medical Device Regulation.

What are the objectives and scope of Medical Device Directive 93 42 EEC?

The Directive: MDD 93/42/EEC The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices. A medical device is defined as any instrument, apparatus, appliance, software, material or other article.

What is the EU Medical Device Directive?

The European Union (EU) Medical Devices Directive (MDD) was introduced in 1994 to regulate medical devices sold in the EU. … As such, medical devices within the EU are subject to requirements intended to protect the health and safety of patients and users of medical devices.

Is MDD still valid?

Yes. Unless suspended or withdrawn, all MDD certificates will remain valid until they expire, or until four years after the date of application (May or June 2024), whichever comes first.

Does MDR replace MDD?

The MDR will replace the existing medical devices Directive (93/42/EEC) (MDD) and the active implantable medical devices Directive (90/385/EEC) (AIMDD). The MDR was published in May 2017, marking the start of a four year period of transition from the MDD and the AIMDD.

Who approves medical devices in UK?

Healthcare products Regulatory Agency (MHRA) In the UK the competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA). The Medical Devices Directive (93/42/EEC) classifies products according to their level of risk. Manufacturers must make sure they comply with all the legislation's relevant essential requirements.

What is meant by CE certification?

The CE mark means that the manufacturer takes responsibility for the compliance of a product with all applicable European health, safety, performance and environmental requirements. CE stands for “Conformité Européenne", the French for European conformity.