Enforcement date: June 14, 1998. that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices; that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class; that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11; that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e). 12.7.2. If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer. The notified body will give due consideration to the opinion of the EMEA when making its decision. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either: 2. Information & Training. Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product. VI and Annex VII Annex 2 and Annex 5 CE marking Article 20 Annex V Article 17 and Annex XII Article 12 and Annex 9 Article 20(6) Article 4(5) first subparagraph Article 4(5)(a) ... medical devices after they have already been put into service such as in the context of second-hand sales. MDD ANNEX VIII – STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES Medical Devices Directive – explained >>> How Medical Devices are regulated in Europe >>> 1. Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules. 2. By derogation from other rules, blood bags are in Class IIb. Classification shall be carried out in accordance with Annex IX. Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof. 5. not to take action on the basis that the vigilance case is clearly not related to the certification granted. a general description of the type, including any variants planned, and its intended use(s). Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. 11.3.1. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. carried out. Under the quality system, each product or a representative sample of each batch is examined and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests are carried out to ensure that the products conform to the type described in the EC type-examination certificate and fulfil the provisions of this Directive which apply to them. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. Available for PC, iOS and Android. 4. Annex VIII: Classification Rules Chapter II: Implementing Rules. Hi Welshery, As per the MDD directive, you … 3. the following Article 9a is inserted after Article 9: 4. the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 have not been applied in full. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. 12.8. ; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer. Powered by TS Q&E - ISO 13485:2016 Medical Device Consulting Services, Please prove you are human by selecting the, Z - Annex (7) VII - REQUIREMENTS TO BE MET BY NOTIFIED BODIES, Annex VII - Requirements to be met by notified bodies, ANNEX I - General Safety and performance requirements, core data elements to be provided to the UDI database together with the UDI-DI in accordance with articles 28 and 29, General Safety and performance requirements. The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device. 1. 3.1.1. Surveillance activities and post-certification monitoring. the solutions adopted as referred to in Annex I, Chapter I, Section 2. the clinical evaluation referred to in Annex X. the draft label and, where appropriate, instructions for use. 3. Or a critical evaluation of the results of all clinical investigations made. Phone: 1.800.472.6477 Fax: 732.548.4085. International Offices It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. the nature and duration of body contact and the specific associated biological risks, the interface with the risk management process, and. The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which conform to the type described in the EC type-examination certificate and to the requirements of the Directive which apply to them. Stand alone software is considered to be an active medical device. Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC. In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan. 7.4. be linked to any organisation which itself provides consultancy services as referred to in point (d). evaluate and verify a manufacturer’s compliance with relevant Annexes. Where in exceptional circumstances the fulfilment of the qualification criteria set out in Section 3.2. cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry out specific conformity assessment activities. conduct an in-depth review of the clinical evaluation as most recently updated by the manufacturer based on the manufacturer’s post-market surveillance, on its PMCF and on clinical literature relevant to the condition being treated with the device or on clinical literature relevant to similar devices, clearly document the outcome of the in-depth review and address any specific concerns to the manufacturer or impose any specific conditions on it, and. the supervision of the notified body’s finances; the activities and decisions taken by the notified body, including, the delegation of authority to personnel and/or committees, where, the interaction with the authority responsible for notified bodies and the obligations regarding communications with other competent. The certificate must contain the conclusions of the examination, the conditions of validity, the data needed for identification of the approved design, where appropriate, a description of the intended purpose of the product. Medical Device Directive. Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures. review the manufacturer’s procedures and documentation relating to clinical evaluation, address the interface between the manufacturer’s risk management, carry out the specific procedures referred to in Sections 5.2 to 5.4 of. 12.7.4. The notified body shall have documented procedures in place for the review of the manufacturer’s procedures and documentation relating to the evaluation of pre-clinical aspects. 6.2. 3. 9.1. For active implantable medical devices: Annexes 1, 6 and 7 of Directive 90/385/EEC. and review and audit requirements and provisions adopted by the manufacturer, including those in relation to fulfilling the general safety and performance requirements set out in Annex I. Taken together, Annex I and UDI impose significant new requirements on all stakeholders in the supply chain for medical devices, from manufacturers down to healthcare professionals. The notified body shall keep at the disposal of the national authorities the relevant documents assessing the subcontractor's qualifications and the work carried out by the subcontractor under this Directive. the assessment of conformity of the design with this Regulation, and for taking account of Sections 4.5.4. to 4.5.6. risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure and acceleration. follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); in this case, point 4 of Annex II is not applicable; or, he has verified the, mutual compatibility of the devices in accordance with the manufacturers' instructions and has carried out his operations in accordance with these instructions; and, he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and. 7. The notified body shall clearly document the extent and limits of duties and responsibilities and the level of authorisation of the personnel, including any subcontractors and external experts, involved in conformity assessment activities and inform those personnel accordingly. Monitoring of competences, training and exchange of experience. | Medical Devices. 2. The manufacturer must ensure application of the quality system approved for the manufacture of the products concerned and carry out the final inspection, as specified in Section 3, and is subject to the Community surveillance referred to in Section 4. 12.8.2. The opinion of the EMEA must be drawn up within 210 days after receipt of valid documentation. Instructions for use must be included in the packaging for every device. the appraisal and analysis of the available pre-clinical data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I. the planning, conduct, assessment, reporting and updating of the clinical evaluation as referred to in Annex XIV. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure. The notified body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Directive either by examining and testing every product as specified in Section 5 or by examining and testing products on a statistical basis as specified in Section 6, as the manufacturer decides. a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC. ‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials; ‘placing on the market’ means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished; ‘putting into service’ means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose; ‘authorised representative’ means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive; ‘clinical data’ means the safety and/or performance information that is generated from the use of a device. In choosing representative sample(s) the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. the documentation referred to in the fourth indent of Section 3.1. the documentation referred to in the seventh indent of Section 3.1. the decisions and reports from the notified body as referred to in Sections 4.3 and 4.4. a written declaration specifying that no application has been lodged with any other notified body for the same products. the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product; cosmetic products covered by Directive 76/768/EEC ; human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells, with the exception of devices referred to in paragraph 4a; transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a; transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue. the verification of the qualification of products covered by those applications as devices and their respective classifications. the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of product, including control of products which fail to conform. 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