Register/Notify your MDD-Medical Devices and IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking Specialists based in London/UK. Click here to get FREE Guide Now!

Guidelines   for Classification of   Medical Devices Looking for an EC/EU European Authorised/Authorized Representative? Register/Notify your MDD-Medical Devices and IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking Specialists based in London/UK. Click here to get FREE Guide Now! FAQ- Questions & Answers on CE Marking Is my product a Medical Device (MD) or In Vitro Diagnostic Medical Device (IVD)? How to classify Medical Devices (MD)? Which category does an In Vitro Diagnostic Medical Device (IVD) fall into? Why must a medical device manufacture appoint a European Authorized Representative? Why must inform/notify/register with the Competent Authority? When to inform/notify/register with the Competent Authority? Who should apply/register with the Competent Authority? Changes to registered details? Class I (including Is & Im) medical devices CE Marking procedures Class IIa medical devices CE Marking procedures Class IIb medical devices CE Marking procedures Class III medical devices CE Marking procedures IVD-In Vitro Diagnostic medical devices CE Marking procedures Medical device CE Marking procedures Steps to obtain CE Marking for your medical devices Legal basis for medical devices Cost and fees for the CE Marking of medical devices Click here to contact us for a quotation Other CE Publications Related to Medical Devices: 93/465/eec: Conformity Assessment Procedures & CE Marking Rules 2001 Guidelines for Classification of Medical Devices Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec. 90/385/eec: Directive of Active Implantable Medical Devices 98/79/ec: Directive of In Vitro Diagnostic Medical Devices Guidelines to Medical Devices Vigilance System List of Harmonised (European) Standards for Medical Devices List of Notified Bodies for Medical Devices Directive Guidelines for Conformity Assessment of Breast Implants According to Directive 93/42/eec Guidelines on Assessment of Medical Devices Incorporating Materials of Animal Origin Guidelines on Medical Devices With Measuring Function Guidelines on Medical Devices: Subcontracting – Quality System Related Guidelines on Medical Devices: Treatment of Computers used to program Implantable Pulse Generators Guidelines on Medical Devices: Demarcation with other Directives- Directive 89/336/EEC EMC & Directive 89/686/EEC PPE Guidelines on Medical Devices: EMC Requirements Guidelines on Medical Devices Labelling: USE-BY DATE Guidelines on Medical Devices Labelling: Translation procedures Guidelines on Homogeneous Production Batches Depending on its Intended Purpose, a medical device may be classified as Class I (including Is & Im), Class IIa, IIb and III, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required. All Class Is, Im, IIa, IIb and III medical devices require the intervention of third party: the so-called Notified Body. Classification of a medical device will depend upon a series of factors, including: how long the device is intended to be in continuous use whether or not the device is invasive or surgically invasive, whether the device is implantable or active whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device. The classification rules are set out in Annex IX of the directive. This annex includes definitions of the terminology used in the classification rules.  Click to buy a FULL version (PDF format, 42 pages) of this Guideline now !   CONTENTS  Click to buy a FULL version (PDF format, 42 pages) of this Guideline now !   It is not feasible economically nor justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures available. A graduated system of control is more appropriate. In such a system, the level of control corresponds to the level of potential hazard inherent in the type of device concerned. A medical device classification system is therefore needed, in order to channel medical devices into the proper conformity assessment route. In order to ensure that conformity assessment under the Medical Device Directive functions effectively from January 1995, manufacturers should be able to know as early as possible in which class their product is. Identification of the class of each individual type of device by a committee procedure would have taken too long to achieve this goal. It was therefore decided to set up a system of classification rules within the directive, so that each manufacturer could classify its own devices. A simple set of classification rules based on technical features of medical devices existing now and in the future is impossible, because of the vast number and the changing nature of variables involved. The human body, however, is a relatively unchanging element of the equation. The European legislator established therefore a classification concept which is essentially based on potential hazards related to the use and possible failure of devices taking account of technology used and of health policy considerations. This approach in turn allows the use of a small set of criteria that can be combined in various ways: duration of contact with the body, degree of invasiveness and local vs. systemic effect. It is recognized that although the existing rules will adequately classify the vast majority of existing devices, a small number of difficult cases may arise. Such cases may in particular include the determination of the borderline between two classes. In addition there may be devices that cannot be classified by the existing rules because of their unusual nature or situations where the classification would result in the wrong level of conformity assessment in light of the hazard represented by the device.  Click to buy a FULL version (PDF format, 42 pages) of this Guideline now !   Graphical Summary medical devices classification guidance chart for initial identification of probable device class  Click to buy a FULL version (PDF format, 42 pages) of this Guideline now !   back to top of this page Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:- Does my product need CE Marking in order to be sold/exported on/to the European Market? How to obtain CE Marking for my product? How can Wellkang Consultant Firm help me to obtain CE Marking for my product? Wellkang can be your Authorized Representative in Europe for CE Marking purpose ! Buy a Directive or Guideline on Directive in Chinese, English, French, Portuguese and/or Spanish. Complete list of all CE Marking Directives and Guidelines to Directives Complete list of all (more than 1000) Notified Bodies for CE marking Complete list of all European and/or international standards related to CE marking 85/374/eec: Directive of Liability for Defective Products (for all products) 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products) 2000: (Proposal for a new) General Products Safety Directive (for all products) 92/59/eec: Directive of General Products Safety (for all products) 93/68/eec: "CE Marking" Directive (for all products) 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products) Guide to Implementation of directives based on new approach & global approach (for all products) 73/23/eec: Directive of Low Voltage Electrical Equipment Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec 98/37/ec: Directive of Machinery 2000: Comments on Directive of Machinery 98/37/ec Useful Facts relating to Machinery 98/37/ec 2001 Proposal to amend Directive of Machinery 98/37/ec 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE) 2001 Framework of implementation of Directive 99/5/EC R&TTE 2001 Guidance on Directive 99/5/EC R&TTE 2000/9/ec: Directive of Cableway Installations to Carry Persons 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors 1999 Agreement on Mutual Recognition of conformity assessment between European Union and United States of America 2000 amendation to Agreement on Mutual Recognition of conformity assessment between European Union and United States of America 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Canada 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Australia 1998 Agreement on Mutual Recognition of conformity assessment between European Union and New Zealand 1999 Agreement on Mutual Recognition of conformity assessment between European Union and Israel 2001 proposal Agreement on Mutual Recognition of conformity assessment between European Union and Japan   | home/first page | back to where you were | back one page | top of this page | next page |