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The Medical Devices Directive (MDD: 93/42/EC)The Medical Devices Directive is concerned with all medical devices, from sterile Gants to electronic monitoring equipment and complex MRI-scanners. COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices Equipment classes Medical devices are classified according to 2 criteria, the level of invasiveness , and the accompanying level of risk to the patient.
Class I equipmentClass I: Non-invasive low risk (electric/electronic) equipment or devices without a monitoring function. For this type of medical equipment the so-called manufacturers declaration is applicable and no involvement of any certified or notified body is required. Most Class I equipment is not invasive at all, and should not administer anything to the patient, no medicines nor energy. Class IIa/b equipmentClass II : Non-invasive or short time invasive equipment or intensive patient skin contact or administration of body fluids or medicinal fluids or gases. Class II equipment (and up) requires the involvement of a Notified Body that will approve customers documentation and/or QMS. The diagram below shows the conformity assessment modules available as a function of the device class.
Design and Production of medical devices need to be under control (but Class I) of an internal Quality Manufacturing System according to Annex II or V in the MDD. Many companies choose to apply Prepare Technical Construction FileA Technical Construction File (TCF) is mandatory. The full construction details of the equipment and all measures taken to comply to the directive's Essential Requirements must be created and maintained. Dependent of the Class and manufacturers choice of conformity assessment module the TCF need approval of an Notified Body. Appoint a EC-REP As a medical devices manufacturer you will need to establish a EC authorized representative for your product line. The name of the EC REP needs to be mentioned on your products. (see below)
Audit Dependent of the Class and manufacturers choice of conformity assessment module the your Quality system will be audited by an appointed Notified Body. Registration Class I Medical Devices need to be registered at a competent authority. There is more to the MDD: Essential requirementsThe Medical Devices Directive uses harmonized standards to show presumption of compliance with the essential requirements of the directive:
EMC for medical devicesThe medical equipment should comply with EN 60601-1-2:2001 and several of the many subparts. Electrical SafetyThe equipment should comply to EN 60601-1:2007 and applicable subparts, notably software. Risk Management AssessmentA full risk assessment is part of the approval procedure for medical devices. ce-test may perform such a risk assessment according to the FMEA (Failure Mode and Effect Analysis) and a bi-directional TOP-DOWN-TOP FTA (Fault tree Analysis) methods. Other methods are acceptable. TraceabilityProducts need to be fully traceable, both at the production stages (where do components come from) and in the marketing stage (to who the products are sold) . ce-test can help you with the requirements for traceability. VigilanceThe manufacturer needs to set up and maintain a system where accidents and "near accidents" with the device will be adequately reported to the authorities. In combination with the required traceability of the product, this will allow product recalls if required. Post market surveillanceThe manufacturer needs to watch for any improvement to the safety of the product -to the state of the art-, and implement them in the final product as soon as possible, even after the product has been brought on the market. TestingThe EN 60601-x-y standard series contains extensive requirements for patient touch current, dielectric testing and single fault requirements as well as EMI and susceptibility tests. Labeling Products need to labeled so as they can b used safety by the addressed customer. This includes a set of warnings and markings for common hazards, such as sterilization warnings, date of use, and other warnings. A number of symbols have been defined in EN 980:2008 and in ISO 15223:2009 that may be used without further explanation. We provide True Type Fonts to assist you in accurate labeling. Compliance tests ce-test has been performing a number of medical equipment assessments , both in the Class I and Class II categories.Examples of products we assessed are:
We will be happy to provide you with a suitable quote for type testing your equipment according to the MD directive: ask a quote here EC REP ( European Authorized Representative)
As a medical devices manufacturer you will need to establish a EC authorized representative for your products. The name of the EC REP needs to be mentioned on your products.
The EC REP is a legal entity designated by you to assist in the compliance process, and should be considered as a neutral compliance partner in Europe. EC regulations require you to have such a EAR, that should remain on EC soil. It's main responsibilties are (among others):
We stronly advise any Non-European manufacturers of Medical Devices to appoint a independent EAR in Europe. You should not appoint any of your commercial representatives, as the name of the EAR will be mentioned on the product label. ce-test, qualified testing has a EC REP service. We will hold your files, carry out assessments with you and be a contact point between you and the authorities. Directive Amendment 2007/47/EC to 93/42/EC Per 2010-03-21 directive 93/42/EC has been modified by the Amendments listed in 2007/47/EC. This directive adds a number modifications to the directive:
Download an interpretative Document from the EC ce-test, translation service We provide translation service for the documentation (IFU) of your product, but also the GUI software incorporated into your product into EC official languages. ce-test, your turn key partner in compliance for medical devices.
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ce-test, qualified testing bv | rotterdam | the netherlands | +31 10 4152426 | cetest@cetest.nl |
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