A medical device manufacturer has to follow Conformity Assessment Procedure before placing the device on the EU Market. These conformity assessment procedures are documented in Article 52 of the EU MDR 2017/745 for Medical Devices & Article 48 of EU IVDR 2017/746 for Invitro Diagnostic Medical Device. There are number routes listed in this Articles, the manufacturer has to select the route depending on the Class and Type of the Device. Conformity assessment is depended on following key annexures of the regulations. Those are: Annex IX- CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION. Annex X- CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION. Annex XI- CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION. Let us understand the concept of these annexures in detail. 1. ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION The manufacturer is supposed to maintain a Quality Management System and it shall be subjected to Audit and Surveillance. The notified body will audit the Quality Management System to verify its compliance against the regulatory requirements, this audit will be conducted at manufacturer’s premises or on the premises of the manufacturer’s suppliers and/or subcontractors as per the requirement. After Audit, if the requirements are met, the notified body shall issue EU quality management system certificate. For Class IIa, Class IIb & Class III medical device & Class C & Class D IVD Devices, surveillance audit shall be conducted at least once in a year and an unannounced audit at least once in 5 years. During the unannounced audit the Notified Body shall test adequate sample of the device from the Market or from the manufacturing Process and if any non-compliance is found they shall suspend or withdraw or add Restrictions on the Certificate. During the assessment of Technical Documentation as per Annex II & Annex III, the notified body shall also conduct required test in relation to the device or may ask the manufacturer to carry those tests. After the assessment, the Notified body will issue the EU technical documentation assessment certificate. When any substantial change is planned by the manufacturer, it is supposed to be informed to the notified body. The notified body will assess the change and conduct audit if necessary and a supplement to the EU QMS certificate & EU Technical documentation assessment certificate will occur. 2. ASSESSMENT BASED ON TYPE-EXAMINATION In this approach the notified body certifies the device on the basis of its representative sample production envisaged, its technical documents and its life cycle processes. To be clear Production envisaged means the device has not yet arrived at production phase, it shall be produced in future on the basis of this representative sample once it is EU Certified. The notified body shall be kept available with the representative sample by the manufacturer/applicant. As per regulatory requirement, relevant device tests shall be carried out by the Notified body or they may ask the applicant to provide those test results. The Examination and Assessment of Technical documentation shall be performed by the Notified Body and they shall map out a report. EU type Examination Certificate shall be issued. Approval from the Notified Body is required before changes (which may affect the GSPR or with the conditions prescribed for use) to the approved device is planned. A supplement to the EU Type Examination Certificate shall be issued after examination of the planned change by the Notified Body. 3. ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION This approach is used to ensure that the device which is already issued an EU Type Examination certificate conforms to the TYPE and meet the regulatory requirement. There are two possible approaches i.e., Production Quality Assurance and Product Verification. In Production Quality Assurance, the manufacturer shall implement and maintain the Quality management system and shall follow the surveillance activity. The notified body shall issue an EU Quality assurance Certificate if the device conforms to the Type described in EU Type examination certificate. In Product Verification, after examination of each manufactured device the manufacturer shall issue EU Declaration of Conformity. Examination and testing of Each Product shall be carried out by the Notified body as per the regulatory requirements. The Notified body shall fix or have fixed its identification number on each approved device and shall write down an EU product verification certificate.
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