5. the documentation referred to in Section 2. the certificates referred to in Sections 5.2 and 6.4. where appropriate, the type-examination certificate referred to in Annex III. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4); the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative. The manufacturer may, on the responsibility of the notified body, affix the notified body's identification number during the manufacturing process. 12. for each specific project, provide a detailed report which shall be based on a standard format containing a minimum set of elements determined by the MDCG. For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’. It must include the documents needed to assess whether the product conforms to the requirements of this Directive, as referred to in Section 3.2 (c). The personnel shall be required to complete written statements indicating their compliance with confidentiality, independence and impartiality principles. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced. 3. Conformity assessment is the method by which a manufacturer demonstrates that their devices comply with the requirements of Directive 93/42/EEC. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product(s) concerned, an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes. 3.3.2. EC declaration of conformity • Annex VIII . The notified body and the manufacturer, or his authorized representative, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes II to VI. the specific characteristics of the product as indicated by the prescription. Where one or more of the samples fails to conform, the notified body must take the appropriate measures. investigation, replacement or modification of the anatomy or of a physiological process. If the notified body is a legal entity that is part of a larger organisation, the activities of that organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented. Conformity Assessment . • Invasive Devices, including devices that are invasive via a body ... Annex X Part A is similar to Annex V of the Medical Devices Directive, in that it is a review of the manufacturer’s QMS for manufacturing and final inspection of the devices. 7.6. This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer. View All. an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved. 6. 2. defining how and when surveillance activities of manufacturers are to be conducted. The assessment procedure must include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers to inspect the manufacturing processes. The notified body shall require all personnel to formally commit themselves by a signature or equivalent to comply with the procedures defined by the notified body. are aware of Union and national law in force on devices, relevant harmonised standards, CS, guidance documents and the results of the coordination activities referred to in Section 1.6; and. It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration. Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2). 4.4. The notified body shall identify at least one individual within its top-level management as having overall responsibility for all conformity assessment activities in relation to devices. It must notify the manufacturer of its decision. clearly document decision making and approval steps including approval by signature of the members of personnel responsible. After completing this procedure, he can affix the CE mark. failure to meet the essential requirements referred to in Article 3; incorrect application of the standards referred to in Article 5, in so far as it is claimed that the standards have been applied; it shall immediately so inform the Member State which took the measures and the other Member States. The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. if they may be connected to an active medical device in Class IIa or a higher class. 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. Definitions for the classification rules 52 1.1. 7. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body. Such personnel shall be in sufficient numbers to ensure that the notified body in question can perform the conformity assessment tasks, including the assessment of the medical functionality, clinical evaluations and the performance and safety of devices, for which it has been designated, having regard to the requirements of this Regulation, in particular, those set out in Annex I. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. 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. are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates. be the designer, manufacturer, supplier, installer, purchaser, owneror maintainer of devices which they assess, nor the authorised representative of any of those parties. It shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes II, IV, V and VI. 1. the completeness of those applications with respect to the requirements of the relevant conformity assessment procedure, as referred to in the corresponding Annex, under which approval has been sought. have documented procedures, sufficient expertise and facilities for the verification by examination and testing of every product in accordance with Part B of Annex XI; establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility in order to: document its rationale for the selection of the parameters referred to in point (b); have documented procedures to carry out the appropriate assessments and tests in order to verify the conformity of the device with the requirements of this Regulation by examining and testing every product as specified in Section 15 of Annex XI; have documented procedures providing for the reaching of an agreement with the applicant concerning when and where necessary tests that are not to be carried out by the notified body itself are to be performed; and. Article 10 shall be amended as follows: the following subparagraph shall be added to paragraph 2: the following paragraph shall be inserted: ‘In the event of a decision as referred to in the previous paragraph the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measures to be taken.’, devices which conform to the rules in force in their territory on 31 December 1994 being placed on the market during a period of five years following the adoption of this Directive, and. The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination. The evaluation of this data, hereinafter referred to as ‘clinical evaluation’, where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on: 1.1.1. Publication: Official Journal of the European Communities, Volume 36, No. The notified body will give due consideration to the opinion of the EMEA when making its decision. All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class III. In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy. MDD ANNEX VI – EC DECLARATION OF CONFORMITY Medical Device Directive 93 42 EEC (Product Quality Assurance) Information & Training. 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. The MDR entered into force in 2017 with a three-year transition period. 2.3.7. The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb. Where appropriate, the instructions for use must contain the following particulars: 1. For low risk medical devices (Class I, e.g. Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions: 1. 3. Application of the classification rules shall be governed by the intended purpose of the devices. Such procedures shall provide for the identification, investigation and resolution of any case in which a conflict of interest may arise, including involvement in consultancy services in the field of devices prior to taking up employment with the notified body. 3. 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. the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance). If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use. 2. Annex VI . 1.1.2. Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilized prior to use, minimize the risk of microbial contamination; the packaging system must be suitable taking account of the method of sterilization indicated by the manufacturer. The records shall contain a rationale for defining the scope of the responsibilities for each of the assessment personnel and records of the conformity assessment activities carried out by each of them. Stand alone software is considered to be an active medical device. 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. That review shall at a minimum, verify that personnel: The notified body shall have in place documented processes and sufficiently detailed procedures for the conduct of each conformity assessment activity for which it is designated, comprising the individual steps from pre- application activities up to decision making and surveillance and taking into account, when necessary, the respective specificities of the devices. the natural or legal person that applied for conformity assessment has been informed of the requirements referred to in the first and second indent. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system. The notified body in question shall take full responsibility for the tasks performed by subcontractors. The label must bear the following particulars: 13.4. ensure that records that are sufficient to provide a discernible audit trail are available for quality management system audits, clearly document the conclusions of its assessment of clinical evaluation in a clinical evaluation assessment report, and. EC verification is the procedure whereby the manufacturer or his authorized representative ensures and declares that the products which have been subject to the procedure set out in Section 4 conform to the type described in the EC type-examination certificate and meet the requirements of this Directive which apply to them. Fairs, exhibitions, demonstrations, etc trial now to save yourself time money. ) taken and Annex ’ s compliance with confidentiality, independence and impartiality of notified bodies • XII... Respective classifications 5 September 2012 devices where the notified body may be connected to an medical! 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