Is 93 42 EEC still valid?

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).

What is MDD standard?

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. Compliance with the revised directive became mandatory on 21 March 2010.

What is CE MDD?

The Medical Device Directive is intended to harmonize the laws related to medical devices within the European Union. In order to legally place medical device(s) on the European market, manufacturer(s) should comply with the requirements of the MD Directive.

What is the difference between MDD and MDR?

The MDR is significantly more comprehensive and detailed compared to the MDD. While the MDD comprises 23 Articles and 12 annexes over 60 pages, the MDR has 123 articles and 17 annexes over 175 pages. The scope of the MDR is wider than that of the MDD.

What is the current version of ISO 14971?

14971:2019
EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO 14971:2007 and the latest version, 14971:2019, remain the standard recommended for medical device risk management purposes.

What is MDR certification?

In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for medical devices, which will soon change under the new Medical Devices Regulation (MDR 2017/745).

Is MDD a mental illness?

Major depressive disorder (MDD), also known as depression or clinical depression, is a serious mental health disorder that can drastically affect a person’s daily life.

Is MDR replacing MDD?

On 26 May, 2021, the Medical Device Directive (MDD) will be replaced by the new Medical Device Regulation (MDR). MDR is designed to be an improved version of MDD, with the major difference being that MDR influences and provides effectiveness to all EU member states.

What is the correct order of risk management activities?

Five Steps of the Risk Management Process

• Step 1: Identify the Risk. The first step is to identify the risks that the business is exposed to in its operating environment.
• Step 2: Analyze the Risk.
• Step 3: Evaluate or Rank the Risk.
• Step 4: Treat the Risk.
• Step 5: Monitor and Review the Risk.

When was the directive 93 / 42 / EEC created?

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from…

When did Directive 2007 / 47 / EC come into effect?

As you are probably aware, EU Directive 2007/47/EC modifies the Medical Devices and Active Implantable Medical Devices Directives, and must be applied starting 21 March 2010. The European Commission guidance indicates that on 21 March 2010 medical devices placed on the market at that time must comply with Directive 2007/47/EC.

What are the current directives of the European Commission?

The European Commission has adopted several implementing measures based on the medical devices directives.

Where can I find the European Medical Devices Directive?

The latest lists of references of harmonised European standards under the medical devices Directives published in the OJ are available on the standardisation webpages on healthcare engineering: Active implantable medical devices, Medical devices, In vitro diagnostic medical devices.