EU REGULATORY FRAMEWORK FOR MEDICAL DEVICES CLASSIFICATION OF MEDICAL DEVICES (MD): Manufacturer determines the CLASSIFICATION of his MD based on Annex IX ‘of MDD and related guidelines (Meddev) ed) reac} ea Cra (er) (low/medium risk) (medium/high risk) (high risk) performance ofthe doves by roving tra al Escontal Raquromert! ld down nthe MDD are mat Grae {and includes a clinical evaluation (Annex X) anda risk assessment . All are based on cinical data ‘Quality Assurance System’ (QAS):to be set up by the manufacturer. Ensures, that each individual device fully meets the standards defined in the technical documentation. Achieved through clealy defined procedures for every step of ‘the manufacturing process, from design phase to final inspection (Annex I or V). Notified Body (NB) aucit: NB assesses the TD and the QAS through an on-site inspection of the manufacturing premises, which takes 2-5 days, NB issues a Conformity Assessment ‘Cerificate’ (Annex II 3.3. or Annex V3.3) PRE-market Conformity assessment procedure (art. 11) Pre-market approval for class. Ill: Manutacture submits TD as a ‘Design| dossier’ to the NB. NB! fascesces it and _iseues! 8 ‘Design-examination| Certificate’ (Annex I rl Manufacturer issues a declaration of conformity stating that each devi is in compliance with the all appicablo Directives and affixes the CE marking oN “nN Manufacturer must keep TD and GAS updated and adapt according o all gained post-market experience . NB regulary audits both, typically once per year (Annex Il, paragraph 9.1) POST-market ‘Market Survellance: done by national Competent Authorities. They monitor all devices on the marke, Le ‘through auaits, product samples, complaints (Article 2) Post-market surveillance system (PMS): to be set up by the manufacturer in order to collect, review and assess all information gained on a device inthe post-market phase. The PMS anintegrated part ofthe ‘qualty assurance system’ and regulery audited by a NB (Annex I, paregraph 3.1). 4) Manufacturer is obliged to REPORT any incident related to his devices to the Competent Authorty (Articles ‘and Annex I, paragraph 3.1) b) A Member State may decide to WITHDRAW, RESTRICT or PROHIBIT the marketing of the device (Gafeguard Clause, Art. 8) * For devices with measuring function or which are sold sterle there ian intervention from the Notified Body wow.eucomed.org