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 the new EU MDR requirements?

In addition, the MDR require the following: There has been a mandatory implementation of the unique device identification (UDI) mechanism that expects to increase the ability of medical device manufacturers and authorities to track specific devices through the supply chain.

Who regulates medical devices in the EU?

EMA is responsible for evaluating the quality, safety and efficacy of marketing authorisation applications assessed through the centralised procedure, including the safety and performance of a medical device in relation to its use with a medicinal product.

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The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021.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

CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

Who needs to comply with EU MDR?

Compliance with this regulation is mandatory for medical device companies (legal manufacturers) that want to market or sell their products in the EEA (European Economic Area). There are 27 EU member countries. The EU MDR in its entirety is applicable to finished medical devices.

What is the current status of the new EU regulations regarding medical devices in the EU?

The IVDR will be fully applicable on 26 May 2022, after a five-year transition period. The MDR and IVDR represent a significant development and strengthening of the existing regulatory system for medical devices in Europe and will replace the original Directives which have been in place for over 25 years.

What is MDR certificate?

What is MDR certification? MDR certification of a medical device verifies that the device meets all of the regulatory requirements for European Union medical devices; the certification is indicated by a CE Mark. In order for medical devices to be certified, your company must implement a Quality Management System (QMS).