What is Directive 2007 47 EC?

of 5 September 2007. amending Council Directive 90/385/EEC on the approximation of the laws of the Member States. relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical.

What is the latest Medical Device Directive?

The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.

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 new medical device regulation?

On 26 May 2021, a new EU medical device regulation (MDR) entered into force. Medical devices cover anything from contact lenses to state-of-the-art surgical equipment. A new in vitro diagnostic medical devices regulation (IVDR) will follow next year, entering into force on 26 May 2022.

When did MDD come into effect?

For instance, when the MDD came into law in 1992, software as a medical device (SaMD) did not yet exist. Software was something that controlled electric machines, and there were no apps that patients could use to monitor their own health.

Is 93 42 EEC still valid?

According to article 120(2) of Regulation (EU) 2017/475 on Medical Devices (the MDR), certificates issued in accordance with Directive 93/42/EEC will remain valid until 27 May 2024 at the latest.

What are essential requirements for medical devices?

What are the Essential Requirements for Medical Device CE Marking…

  • Applicability to your device,
  • The method used to demonstrate conformity with the ER,
  • Reference to the method(s) used, and.
  • Reference to the supporting controlled documents.

What does EC stand for in EC certificate?

European Community
“EC” is European Community – and is the term on older Directives that pre-date the New Legislative Framework (NLF) alignment.