ISO 13485

How to use ISO 13485 to get your devices approved for CE Marking The CE marking may be a gateway to marketing products in Europe, albeit the medical device was produced somewhere aside from the ecu Union. it’s the producer’s mandatory obligation to accumulate and display the CE mark on the device before marketing it within the European Economic Area (EEA). If the medical device is imported from outside the EEA, then this obligation transfers to the importer. The term “CE” is that the short sort of the French phrase “Conformité Européene,” which translates to “European Conformity” in English. ISO 13485 is aligned with European medical device directives; therefore, its implementation helps to satisfy the wants of those directives. Three different directives are applicable to differing types of medical devices in Europe. Both the Medical Device Directive (93/42/EEC) and therefore the Active Implantable Medical Devices Directive (90/385/EEC) are modified by a replacement directive (2007/47/CE). The third directive is that the In Vitro Diagnostics Directive (98/79/EC). Majors steps for acquiring the CE marking on your medical device There are some logical and procedural steps to getting the CE marking on your device. The “old method” required the fulfillment of exceedingly thorough technical conditions. The “new method” comprises more reasonable and uniform requirements for safety and functionality, and therefore the following steps are going to be helpful as you’re employed through it:

1. Identify medical device status: As a medical device manufacturer or importer within the European market, one must identify the category of medical device needed to be marketed. Medical devices are classified consistent with the associated level of product risk into Class I, IIa, IIb, or III. In vitro diagnostics devices are classified into Class A or Class B.
2. Recognize regulatory requirements and their fulfillment: After the identification of medical device status, a medical device supplier or producer has got to recognize the wants of applicable EU directives and fulfill them accordingly. a number of the most areas where these requirements concentrate include: • Suitability for intended application • Medical device safety for the operator and therefore the patient • Justification that medical device benefits supersede the suitable risks. • Impact of transportation and warehousing of the medical device, and therefore the justification that it doesn’t damage production functionality and safety • Requirements for medical product labeling, instructions to be used , and packaging By demonstrating compliance in these areas, the manufacturer proves that the merchandise is safe and is effective for its intended application. ISO 13485 Certification helps suppliers to realize requirements in these areas. 3) Development and preservation of the technical files: this is often also referred to as the technical documentation of a medical device. It comprises evidence of each

manufacturing stage that shows that the merchandise is compliant. The technical files focuses on some common areas, such as: • Medical device components and material specifications • Medical device product specifications • Validation results of producing processes • Risk Management Registry of a medical device • Design verification records for medical devices • Design validation reports and clinical evaluation • Labeling specifications • Instructions to be used With the assistance of technical documentation and records, the manufacturer proves not only that the merchandise is compliant with the wants of the ecu Directives, but also that each one the processes and phases of the manufacturing processes are documented. ISO 13485 Certification helps to satisfy the above requirements through the management of medical device files. 4) Review for product conformity: The supplier or device manufacturer in Europe has got to get review and approval surely devices that fall under Class III (Active Implantable Medical Devices) and every one devices in Classes A and B (in vitro diagnostics devices). Reviewers will assess the conformity of the manufacturer’s testing processes.

The type of review required before approval for the CE mark is decided by the classification of the medical device. These review paths involve the assessment of the following: • Complete Quality Management System review • Product design verification and validation review • Self-declaration of conformity • Review of Quality Management System for manufacturing • Review of Quality Management System for product • Review of batch release The selection of a review path substantially influences the scope and dynamics of the review. this is often the rationale why correct medical device classification is extremely important for suppliers and makers . a top quality Management System supported ISO 13485 helps to satisfy most of those review routes. 5) Declaration of conformity: this is often the last step during which the supplier of the medical device confirms that the device fulfills all obligations identified within the relevant directives. Moreover, it declares that the device has skilled the program of conformity assessment and is manufactured, designed, and qualified as per the technical files developed. The declaration of conformity is documented on a certificate with all declaration statements of conformity. ISO 13485 Certification helps to achieve the CE mark for your medical device:

Because the conformity assessment routes include both design verification and validation review, an ISO 13485 Quality Management System for both products and processes can help manufacturers to possess the specified systems in situ even before pursuing the CE mark for the ecu market. Companies operating outside the ecu market that have already got a top quality Management System founded on ISO 13485 Certification Service can more easily obtain the CE mark for his or her products, as many of directives’ conformity assessment review requirements are already met through implementing the ISO 13485 standard. In some medical products (produced via ISO 13485-compliant systems), a certificate of declaration of conformity by the manufacturer is enough to achieve a CE mark. Visit : ISO 13485 Certification in Germany