Emergo Europe Animation. The Road to CE Marking of Medical Devices. SEMKO (Centre for) Medical Engineering and Physics (Kista, Sweden) Classify the devices manufactured (Annex 9), except for those devices designed for special purposes or intended for clinical investigations (Annex 8). Select and follow the appropriate conformity assessment procedure (Annexes 2–7), based upon the class to which the device belongs (Article 11; see summaries for each class below). Ensure that the device fulfills the essential requirements (Annex 1). Prepare technical documentation (Annex 2, 3, 5, or 7), including a general description of the product, design drawings, the results of the risk analysis, a list of standards applied, test reports, etc.
The manufacturer must declare that the products concerned meet the provisions of the directive. The manufacturer or its authorized representative for the marketing of the product must register its activities with the competent authority of the member country in which the registered business is located. Class IIa Products. CE Mark Machinery, CE Marking Medical Devices, EU Authorized Representative for Medical Devices,FDA 510(k),denovo 510k, ISO 13485, CE, European Union. CE Approval Process for Medical Devices, CE Mark Certification Process. In order to commercialize medical and IVD devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements of the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD) as they apply to your product. For a more detailed look at the European regulatory process, see or download the chart below.
The chart shown illustrates the CE approval process in Europe and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page. Step 1 Determine which EU Medical Device Directive applies to your device: 93/42/EEC – Medical Devices Directive (MDD) or 90/385/EEC - Active Implantable Medical Devices Directive (AIMDD): Step 2 Step 3 Most companies apply the ISO 13485 standard to achieve QMS compliance. Step 4 Step 5 Step 6 Step 7 Step 8. Effective medical device validation introduction manual advance. EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI British Standards presentation. Design and Planning.pdf. Files and Design Dossiers Non Active Medical Devices.pdf. CE Technical Files for Medical Devices. There are many routes that lead to the final objective: medical devices that possess CE marking.
However, the article on conformity assessment didn't mention that manufacturers may encounter some roadblocks along the way. Just as tollbooths, traffic congestion and speed limits can slow one down while driving on European motorways, manufacturers similarly must navigate through many additional obstacles to demonstrate conformity assessment. One element of the route to conformity assessment is a compilation of the technical documentation, commonly given the monikers "technical file" for Class I, Class IIa and Class IIb medical devices and "design dossier" for Class III medical devices. Interestingly, these terms (including the term "technical documentation") are not referenced in the articles of the Medical Device Directive (MDD) 93/42/EEC.
What Regulatory Documentation Is Required? Available Guidance for Technical File Content Common Elements of a Technical File/ Design Dossier Labeling. Technical File.