Übersetzung für "Medizinprodukterichtlinie" in Englisch

How is software currently classified under the 93/42/EEC Medical Device Directive?

The European Medical Devices Directive contains rules by which the products are assigned to three risk classes.

SLG is a Notified Body according to the Medical Device Directive.

The rc_visard does not fall under the purview of the machinery, low voltage, or medical directives.

In the light of the above, taking into account the potential hazards and risks identified by the SCENIHR in terms of the remaining contamination, persistence of chemical residues and alteration of the functionality, the Commission will assess which are the appropriate measures to be put forward in the context of the Recast of the Medical Devices Directives with regards to the reprocessing of single use medical devices in order to ensure a high level of protection for patients.

Nearly 10 years ago, just after entering the 21st century, the most recent revision of the European Medical Device Directive 93/42/EEC (MDD) began, based on a report from the Medical Devices Expert Group.

All the units are certified Medical CE-marked and comply with the Medical Device Directive 93/42/CEE and Pressure Equipment Directive – PED 97/23/CE.

We examine in our in vivo studies products that fall under the regulations of the German Food Law, European Cosmetic Directive 76/768/EEC or European Directive on Medical Devices93/42/EEC.

The following products are classified as medical device according to the medical device directive (93/42/EEC).

The classification as class IIa medical device confirms that all Memmert CO2 incubators INCO comply with the essential safety requirements of the European Medical Devices Directive 93/42/EEC.

The approval procedure for drugs and pharmaceuticals is subject to the EU Directive 2001/83/EU ("Drug Directive"), but medical devices are subject to the EU Directive 93/42/EEC ("Medical Devices Directive") and the EU Directive 90/385/EEC ("Active Implants Directive").

Manufacturers are required to ensure that every new medical device must meet "basic requirements" according to the Medical Devices Directive 93/42/EEC before introducing the product to the market.

This dealt with a request from the Bundesgerichtshof for a preliminary ruling regarding Medical Devices Directive 93/42/EEC, specifically the obligation to monitor products and the associated liability regarding the use of substandard medical devices.

In addition to the technical services we provide the complete documentation according to the requirements of the Medical Device Directive 93/42 / EEC and for the US market 21 CFR part 820.

We have extensive experience in the development of mechatronic systems according to the European Directives (Machinery Directive, Medical Device Directive).

The company is certified in accordance with the ISO 13485 quality management standard for medical devices and the European Directive MDD 93/42 Directive for medical devices.

CE marked - This product is in compliance with the essential requirements of Council Directive 93/42/EEC Medical Device Directive, as amended by Council Directive 2007/47/EC, class IIa

In 2019, Sensoplast once again successfully met the requirements of the relevant standards (BS EN ISO 9001, BS EN ISO 15378 and parts of BS EN ISO 13485 as well as the Medical Device Directive 93/42/EEC MMD).

The European Directive 93/42 / EEC (known as the Medical Device Directive or under the abbreviation MDD) defines the essential requirements to be met by both manufacturers and importers, before the CE marking can be applied to their products allowing these products to be legally sold in the European market.

Our units meet the requirements of the directive for medical devices 93/42/EWG and they are certified according to the medical devices law.

From 21 March 2010, the revised Medical Device Directive will apply and all manufacturers must fully comply or have fully complied if CE marked devices are being placed on the market in Europe.

While many regard the Directive as replacement for the Medical Devices Directive, others consider that it has changed the situation only very little or even imperceptibly.

A new Medical Devices Regulation (MDR) of the EU, which is currently in the final approval process, explicitly requires multilingualism and comprehensibility of the documentation.

In the EU, UL is a Notified Body for the Medical Devices Directive and IVD Directives and Medical Device Regulations.

The Slendertone electrodes for abdominal belts have been modified in line with the medicine products guideline 93/42/EWG by EU changing guideline 2007/47/EG.

The Slendertone replacement electrodes Bottom have been modified in line with the guideline for medical products 93/42/EWG by the EU modification guideline 2007/47/EG.

Since 13 October 2015, consultations have been taking place between the European Council, the European Commission and the European Parliament on the revision of the Medical Devices Directive.