CE and Consultancy for Medical Devices - Active Implantable Medical Device Directive No. 90/385/EEC The Active Medical Device Directive gives manufacturers the opportunity to develop their own compliance program. We guide you through the entire process and assist to optimize your compliance program to meet your product specifications and business needs. The following flowchart gives a brief overview of your responsibilities under the Active Medical Device Directive and shows how mdi Europa can help you: view flowchart AIMDD [ for downloads click to library section ] - Medical Device Directive No. 93/42/EEC The Medical Device Directive gives manufacturers the opportunity to develop their own compliance program. We guide you through the entire process and assist to optimize your compliance program to meet your product specifications and business needs. The following flowchart gives a brief overview of your responsibilities under the Medical Device Directive and shows how mdi Europa can help you: view flowchart MDD [ for downloads click to library section ] - In-Vitro Diagnostics Directive No. 98/79/EC The In-Vitro-Diagnostic Medical Device Directive offers multiple routes to compliance – depending on the specifications and intended purpose of use of your product. mdi Europa guides you through the entire process and assists to optimize your compliance program to meet your product specifications and business needs. The following flowchart gives a brief overview of your responsibilities under the In-Vitro Diagnostic Medical Device Directive and shows how mdi Europa can help you: view flowchart IVDD [ for downloads click to library section ] CE and Consultancy for Electrical & Electronic Equipment - Electro Magnetic Compatibility Directive No. 89/336/EEC Electric and electronic medical devices will have to fulfil the requirements laid down in the EMC Directive in addition to those describe in the applicable medical device regulations. The following flowchart gives a brief overview of your responsibilities under the Directive on Electro Magnetic Compatibility and shows how mdi Europa can help you: view flowchart EMC [ for downloads click to library section ] - Low Voltage Directive No. 73/23/EEC (93/68/EEC respectively) Are you unsure whether your devices fall under the LVD Directive? We can help you to find out and identify the necessary steps together with you. The following flowchart gives a brief overview of your responsibilities under the Low Voltage Directive and shows how mdi Europa can help you: view flowchart LVD [ for downloads click to library section ] CE and Consultancy for Environmental Requirements - Waste Electrical and Electronic Equipment Directive No. 2002/96/EC The Waste Electrical and Electronic Equipment Directive aims at the prevention of waste and to increase the repair, re-use, recycling and recovery of electrical and electronic equipment. mdi Europa specializes in supporting manufacturers of electrical and electronic medical devices to comply with the duties and responsibilities defined by WEEE. - Directive Restriction of use of Hazardous Substances No. 2002/95/EC The RoHS Directive prohibits the presence of lead, mercury, cadmium, hexavalent chromium and certain BFRs in most electrical and electronic equipment. As of today, it is still unclear as to which extend medical devices will fall under this new regulation. Contact mdi Europa to find out about the current status at EU Commission level. Directive on Personal Protective Equipment No. 89/686/EEC The Directive on Personal Protective Equipment describes different routes to reach compliance. mdi Europa guides you through the entire process and assists to optimize your compliance program to meet your product specifications and business needs. The following flowchart gives a brief overview of your responsibilities under the Directive on Personal Protective Equipment and shows how mdi Europa can help you: view flowchart PPE [ for downloads click to library section ] Quality Management A number of different European Directives require manufacturers of medical devices to implement and maintain a quality management system as part of their compliance program. Different routes and standards can be used to comply with the Directives:  mdi Europa will help you to identify the applicable legislation you have to follow and will lead you through the entire process. We offer draft documents, templates and assistance in developing your own, customized quality management system. If requested, we will assist in compiling your own quality manual and procedures. Contact us to for individual quotation, customized to your needs. Technical File Compilation A Technical File is required for all products falling under one of the three medical device Directives, including low risk Class I and custom made devices. mdi Europa will help you to comply with the necessary legislation and assist in ensuring that your Technical File is ready for review by a Notified Body (as and when necessary) or the local Competent Authorities in Europe. Ask for our checklist or request a quotation for Technical File compilation assistance. mdi Europa will make your life easier – at a cost effective price.