Application for Examination of a Quality System according to LVFS 2003:11 (for CE marking o medical devices)

Transcription

1 Company (applicant): hereby applies to, as Notified Body, in accordance with the EG-directive 93/42/EEC (changed 2007/47/EG) for review according to below Review in accordance with 93/42/EEC Annex Annex 2 Full quality assurance 5 Production quality assurance Sterile class I-product Class I measuring function 6 Product quality assurance Class I measuring function The application is regarding New certificate: Revision of certificate No.: Renewal of certificate No. (extension of validity time): Concerning product: Product Concerning quality system: Is the current quality system certified? Yes No If yes, please name -the standard -the certification body Phone: +46 (0) Page 1 (6) For RISE note: Ankom den

2 The applicant confirms: That no corresponding application for conformity assessment covered by this application has been sent to any other Notified Body. That the applicant as the certificate holder allows RISE to publish issued certificates, in listings over certified products. Specific for quality system assessment: That the applicant will fulfill the obligations of the approved quality system; That the applicant will keep the approved quality system valid and effective That the applicant will establish and keep up to date a systematic procedure to review experience gained on products placed on the market, and to implement appropriate means to apply any necessary corrective action. This commitment includes an obligation for us to report accidents and incidents to the MPA in accordance with MDD 93/42/EEC and to follow current recommendations, eg MEDDEV 2.12 / 1, in respect of reporting. Place, date Signature of the person representing the company Clarification/name of the person representing the company This application together with relevant appendix and documentation refererred to in the application is sent to your contact person at RISE according to the model: first_name.last_name@ri.se and to certifiering@ri.se The following information shall be appended: New certificate: If the application is regarding a new certificate documentation in accordance with the appendix shall be appended. Revision: If the application is for revsion of a certificate documentation concerning the changes/additions shall be appended (the appendix can be used as a guide) Renewal of certificate: If the application is regarding renewal of a certificate the following information shall be appended (if relevant) -A description of how the essential requirements have been met -Table of contents of the Technical File -Report regarding risk management -Complete register of articles included in the certificate -List of applied harmonized standards -Example of marking (label etc.) -User manual (in Swedish or English) -Clinical report or clinical or clinical evaluation For sterile products also: -Compilation of sterile validation -Validation of packages Further information of what is needed will be given to you by your contact person at RISE. Page 2 (6)

3 Information about the applicant Legal manufacturer (in accordance with the definition in Law 1993:584 2) Company name: Full postal address: Authorised representative (in accordance with the definition in Law 1993:584 2 g) Invoice address (if other than above) Visiting address: Org./VAT No.: Phone company: company: Internet (www): Contact person: Phone contact person: contact person: Manufacturing places: SNi-code (optional) Information about the manufacturer (if other than applicant): Company name: Full postal address: Visiting address: Org./VAT No.: Phone company: company: Internet (www): Contact person: Phone contact person: contact person: Other information Note If the applicant has activities at several sites or premises or in daughter companies which are part of the scope, we need one register for each of them. Page 3 (6)

4 This is Annex No. 1 Dated: To application dated: Company Signed Documentation required (to be completed by applicant) for review Note: All documentation must be equipped with date and or revision, which is to be updated in case of a new version. Documentation Product description Description or reference (to concerned document/drawing etc.) RISE note The intended use of the device Name to which product category according to LVFS 2003:11, annex 9, the product belongs Name the rationale for the categorization (if you wish, please, append the risk analyses) Name the product code according to Global Medical Device Nomenclature (GMDN): Description of the organization, the amount of employees, ways of manufacturing etc. Name crucial subcontractors used and what services or product they are offering you Do the products contain material of animal origin? If yes, description of the the material Yes No Do the products contain substances from human blood or blood plasma If yes, description Yes No Other information of importance for the mission Page 4 (6)

5 Documentation to be provided with the application: Documentation Quality manual LVFS 2003:11, bilaga 2, 5 resp 6, punkt 3.2 / MDD 93/42/EEC annex 2, 5 or 6 Annex X X X Commitment (Page 2 in this application) X X X Relevant information about the product or product category to which the application relates. The information must contain a general description, intended use, class according to Annex 9 of LVFS 2003: 11, if the product is intended to be combined with other products, etc. X X X Type certificate and accompanying technical documentation (if applicable) X X Planned variants of the product (if applicable) Design drawings, sketches, connection diagrams, including explanations and descriptions X X 1) Description of manufacturing methods X 1) A description of how the essential requirements have been met X (X) (X) Results of design calculations, examinations and performed technical tests, etc. Results of risk analysis together with description of persons who have participated in the risk analysis group A statement of whether the product contains or contains no medicinal product, as well as an indication of relevant tests (X) X X 1) X 1) X 1) Clinical data and trials according to Appendix 10 of LVFS 2003: 11 (if applicable) X 1) Proposals for labeling and, where applicable, operating instructions X 1) 1) This documentation does not need to be attached to the application, but will be requested by RISE for one or more products. (X) May be required for RISE to perform an assessment of the product's class. Page 5 (6)

6 Requirements regarding documentation for medical devices (prior to CE-marking) To ensure a possibility of timely handling of your application for certification of a quality system for medical devices (LVFS 2003:11, annexes 2, 5 or 6), the documentation is expected to be follow the guidance below. Technical documentation When deploying the technical documentation, please use NB- MED/2.5.1/Rec5, rev. 4 (2000), Technical documentation, chapter 4 ( Recommended structure of the technical documentation ). Clinical evaluation It is expected that the devices have been subject to clinical evaluation according to MEDDEV 2.7/1, rev. 4, Clinical evaluation: a guide for manufacturers and notified bodies. Please use the guidance for your documentation The technical documentation should include a clinical evaluation report Biological compatibility Judgment of biocompatibility should be performed according to SS-EN ISO :2009, Biological evalutation of medical devices Part 1: Evalutaion and testing within a risk management process, incl. technical amendment corrigendum 1 (ISO :2009/Cor 1:2010), in particular part 4 ( including part 4 General principles applying to biological evaluation of medical devices and part 7 Interpretation of biological evaluation data and overall biological safety assessment. Risk management Risk management should be performed according to SS-EN ISO 14971:2012 Medical devices -- Application of risk management to medical devices. The risk management report should be according to part 8 ( Risk management report ) in that standard. Essential requirements Compliance to the essential requirements shall be reported in a format clearly showing that all applicable requirements have been considered and handled. In relevant cases it shall be reported how Annex Z in harmonized standards have been managed. Page 6 (6)