What is EU Medical Device Directive?

What is EU Medical Device Directive?

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. Products conforming with the MD Directive must have a CE mark applied.

Do medical devices need to be CE marked?

CE marks. Before a medical device can be launched in the European Economic Area (EEA), it must receive a CE mark. The CE mark confirms that the medical device meets certain “essential requirements” of the European General Medical Devices Directive (i.e. that it is fit and safe for the intended purpose).

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.

How many medical devices are there in the EU?

There are over 500 000 types of medical devices and IVDs on the EU market.

What is CE marking medical devices?

CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union.

How do I check my European CE certificate?

The only way to check a CE mark is to validate the documentation, i.e. the Technical File and Declaration of Conformity. There is no such thing as a “CE certificate” or a “CE mark certificate”, there are only notified body certificates.

How do you classify a EU medical device?

According to the European framework, there are four classes of medical devices: Class I, IIa, IIb and III. The medical devices of Class III hold the highest risk. Today, due to the stricter rules of the new Regulation system, the class of many devices changed.

How many categories of variation does the EU use with respect to medical devices?

All medical devices are placed into one of four graduated categories, using the classification rules listed in Directive 93/42/EEC Annex IX. It is considered more feasible, economically and justifiably, to categorize medical devices rather than all of them being subject to the rigorous conformity assessment procedures.

What is the latest medical device Directive?

Regulatory requirements for medical devices From 26 May 2021, the EU Medical Device Regulation, (MDR (EU) 2017/745) has replaced the EU’s Medical Device Directive (93/42/EEC).

What is the new EU MDR?

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

What was the EU Directive on medical devices?

Directive 93/42/EEC. Short name: Medical devices. Base: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169 of 12 July 1993. Modification: Directive 93/68/EEC [CE Marking] Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.

What are the EU CE marking directives and regulations?

Please find below a list of the CE Marking Directives and regulations (European Union directives/regulations that require the affixing of a CE mark to the products covers by them): Machinery Directive – 2006/42/EC Low Voltage Directive – 2014/35/EU EMC Directive – 2014/30/EU

When did CE marking for medical devices end?

Short name: Medical devices Base: Council Directive 93/42/EEC of 14 June 1 Modification: Directive 93/68/EEC [CE Marking] Directi Directive repealed: 76/764/EEC (repealed as from 1 January 1 Guide for application: Guidance on CE marking for professionals

How does CE mark approval work in Europe?

Gain market access in Europe with CE mark approval. CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the saftey and performance requirements for medical devices in the European Union (EU).