VERORDNUNG (EU) 2017/745 DES EUROPÄISCHEN PARLAMENTS UND DES RATES. So Manufacturers are advised to immediately start mapping the Technical Documentation of the new EU MDR to their available documentation and to start work on filling any gaps. Particular attention must be paid to: 7. This is not an exhaustive list and whilst BSI believes that it accurately reflects the regulatory environment at the time of publication, you should be aware that this is complex and can change. The conformity assessment route for CE marking varies according to the assigned class of device as describes in MDR Article 52 and in the MDR Annex IX, Annex X and Annex XI depending on the device class, manufacturers have some choice regarding the conformity assessment route. If you would like to request MDR services from TÜV SÜD, please use this form to register your interest.. Based on the product classification, the manufacturer must apply for an applicable conformity assessment procedure. Those rules can be found in Annex IX of the MDD. A copy is also to be kept by Authorised Representatives (EU MDR Article 11). (2) A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a CE marking only if its manufacturer or his authorised representative— (a) fulfils the applicable obligations imposed by— (i) Sections 1 to 6 of Annex III, (ii) Annex IV, or (iii) Annex V and either Annex VI or Annex … TÜV SÜD has developed an online service registration form to allow us to systematically process your request. Unfortunately, this question has to be answered with a “no”. (1) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44). We offer an easy and low-cost software solution to manage UDI and communicate with EUDAMED. Plus Annex III of the EU MDR requires more than fifteen additional elements in the “Technical Documentation on Post Market Surveillance”. EU MDR. Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council (1) shall be demonstrated. The proof is considered valid if a certificate of biocompatibility according to ISO 10993 ff by a certified test laboratory can be provided for the material in question. The Technical Documentation required by the current Medical Device Directive (MDD) is largely left to the Manufacturer’s discretion. Please prove you are human by selecting the Car. MassimoP Z - Annex (2) II - Technical documentation annex, ANNEX II, mdr, technical documentation ANNEX II (PART 1) Technical documentation. Try it now for free! Annex II of the new EU MDR prescribes more than forty specific elements for the content of the (primary) “Technical Documentation”. Meaning that, eventually, every technical documentation has the same form of content, but as far as the general structure or the … ANNEX II. The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex. Regulation (EU) 2017/745. However, it is not identical to the GHTF STED as there are a number of additional sections in the new EU MDR Annex II which reflect the specific focus of the European authorities on certain topics; information on medicinal substances, on tissues or cells of human or animal origin, on substances intended to be introduced into the human body. EC DECLARATION OF CONFORMITY (Full quality assurance system) The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the products concerned, as specified in Section 3 and is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5. Requirements Evidence of the biological safety of a medical device Providing this evidence is facilitated if biocompatible (raw) materials are used. It is a required item in the Technical Documentation (Annex II, 1.1) (a) general description of the device including its intended purpose and intended users; The number of requirements of GSPR’s (Annex I- General Safety and Performance requirements) has increased under MDR compared to the number of Essential Requirements under MDD. In contrast to the MDD, the new EU MDR is consistent throughout on the subject of the Technical Documentation. Annex II (EC Declaration of Conformity – full quality assurance system) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the regulatory requirements necessary for compliance with the Directive employing an acceptable quality assurance system. Don't forget that you need to also check the machinery directive as per Article 1.12: 12. It is another required item in the Technical Documentation (Annex II, 1.1): (f) the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII; MDD ANNEX II – EC DECLARATION OF CONFORMITY (Full Quality Assurance System) The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 (of the Directive) ensures and declares that the products concerned meet the provisions of the Directive which apply to them. No special regulations apply for certificates according to Annex 4/IV issued after the MDR came into force. 6. Common specifi… The Commission shall immediately transmit those documents to the relevant expert panel referred to in Article 106. 1223/2009 und zur Aufhebung der Richtlinien 90/385/EWG und 93/42/EWG des Rates In the absence of such studies, a justification shall be provided. The MDD’s “Design Dossier” has been dropped from the EU MDR. TECHNICAL DOCUMENTATION. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory. Please see below for example or explanation for EU MDR Technical Documentation. April 2017. über Medizinprodukte, zur Änderung der Richtlinie 2001/83/EG, der Verordnung (EG) Nr. Annex II: Technical documentation; pre-clinical and clinical evaluations. MDR Application Procedure. PRODUCT VERIFICATION AND VALIDATION. This will provide a high … (11) La législation de l'Union, et en par ticulier le règlement (CE) no 1394/2007 du Parlement européen et du Conseil (1) et la directive 2004/23/CE du Parlement européen et du Conseil (2), est lacunaire en ce qui concer ne cer tains produits fabr iqués à l'aide de dér ivés de tissus ou de cellules d'or igine humaine non viables ou rendus Under the EU MDR, Notified Bodies issue an EU quality management system certificate according to Annex IX of Regulation (EU) 2017/745. Die technische Dokumentation enthält die in den Anhängen II und III aufgeführten Elemente. GSPR is replacing the Essential Requirements that were on the MDD Annex I. In the opinion of the author, the Technical Documentation is one topic which can and should be addressed by Manufacturers without delay. Chemical, physical and biological properties 7.1. Luckily, the requirement on quality management systems has been clarified in article 10, and now contains a list of things that must be addressed. The MDR defines various documentation requirements, which will be new for all manufacturers, not only for those who produce class III devices. Additional information required in specific cases. Mar 8, 2019 #14. This guidance provides information on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. MassimoP Z - Annex (2) II - Technical documentation annex, ANNEX II, mdr, technical documentation ANNEX II (PART 2) Technical documentation. Annex II: Technical Documentation •Information to allow key design stages to be understood •Description of manufacturing processes •Manufacturing validations, monitoring and final product testing •Identification of all suppliers and sub- contractors undertaking design or manufacturing processes for the manufacturer 11 MDR 2017 / 745 Annex II Medical Device Technical File is a summary document prepared by … Introduction Definitions Classification Conformity assessment UDI and Eudamed Supply chain obligations PMS and vigilance Contact 14 Placing a device on the market … The above criticisms cannot be made of the new European Union Medical Device Regulation (EU MDR) however. The contents are described, but rather vaguely, in a few bullet points in the MDD’s Annex VII. It is also one of the items the “Person responsible for regulatory compliance” has to ensure is kept up to date (EU MDR Article 15) and it is to be assessed by the Notified Body (EU MDR Annex IX chapter II). That’s not to underestimate the amount of work that will be required to switch from the current MDD to the new EU MDR. Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right separately from the device with which they are used. All Annex 4/IV certificates issued before the MDR came into force will become invalid by May 27, 2022, at the latest. Annex II to VII in the MDD outlines the requirements on quality management systems depending on if the classification shows an assessment route, or anything but complete. Table – Conformity Assessment Options Device Class Conformity Assessment Procedure Class […] Under the MDD, Notified Bodies issue a certificate that confirms the quality management system of the manufacturer satisfies the requirements of Annex II of Directive 93/42/EEC. Der Kommission wird die Befugnis übertragen, gemäß Artikel 115 delegierte Rechtsakte zur Änderung der Anhänge II und III unter Berücksichtigung des technischen Fortschritts zu erlassen. (11) Union legislation, in par ticular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1) and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplete in respect of cer tain products manufactured utilising der ivatives of tissues or cells of human or igin that are non-viable or are rendered Annex II of the new EU MDR prescribes more than forty specific elements for the content of the (primary) “Technical Documentation”. MDD ANNEX II – EC DECLARATION OF CONFORMITY (Full Quality Assurance System) The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 (of the Directive) ensures and declares that the products concerned meet the provisions of the Directive which apply to them. (EU MDR 2017/745 ANNEX II TECHNICAL DOCUMENTATION: The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organized, readily searchable and unambiguous manner and shall include the elements listed in this Annex.) There are now 22 rules in Annex VIII of the MDR. The MDR does provide guidelines as to which content must be present in a technical documentation for approval in the European area, however, it does not give explicit information in terms of the structureand uniformity of the documents. Class IIa (medium risk) Class IIb (medium/high risk) Class III (high risk) Device Classification rules The MDD contained 18 rules for classification. ANNEX II, Last update: 24/11/2020 LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS Reference number Substance identification Chemical name / INN CAS Number EC Number Update Date 1 N-(5-Chlorobenzoxazol-2-yl)acetamide 35783-57-4 - 17/10/2010 2 (2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts 51-84-3 200-128-9 17/10/2010 3 Deanol aceglumate (INN) 3342 … Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. The notified body shall transmit its clinical evaluation assessment report, along with the manufacturer’s clinical evaluation documentation, referred to in points (c) and (d) of Section 6.1 of Annex II, to the Commission. Implementing rules. There is also mention of a “Design Dossier” in MDD Annex II but this is not further defined in the MDD. Technical documentation (Annex II of the MDR and IVDR) 3. The Technical Documentation is to be supplied to Competent Authorities when requested. The (primary) Technical Documentation of Annex II of new EU MDR is clearly based on the so called summary technical documentation or STED, developed by the former Global Harmonisation Task Force (GHTF). ANNEX II. Yes: ☐ ANNEX XVII – Correlation table showing Council Directive 90/385/EEC, Council Directive 93/42/EEC and the MDR Need help understanding what to do next? In this first section, you need to introduce your device. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service; 6.2. Specifically, Section 4 – General Safety and Performance Requirements states: 3.2. You can still upgrade them to the GSPR that you can find on annex I of MDR … MDR Application Procedure. TÜV SÜD has developed an online service registration form to allow us to systematically process your request. Annex 1 to these Guidelines describes the mandate, Annex 2 describes Annex I Chapter II Section 10.4. of the MDR regarding the use of substances that could be released from the medical device and pose a risk to patients, and Annex 3 describes the definitions used in these Guidelines. With the MDR, the rules are expanded. Mar 8, 2019 #14. MassimoP Z - Annex (2) II - Technical documentation annex, ANNEX II, mdr, technical documentation ANNEX II (PART 1) Technical documentation. However, it is likely that these certificates will also have a limited period of validity. Annex II Technical File Documentation. The intended purpose is usually a short statement of two or three sentences that focuses on what the device is intended to be used for. The European Union Medical Device Regulation of 2017. In contrast, the Technical Documentation on Post Market Surveillance described in Annex III of the new EU MDR is less like a technical dossier, more like a collection of the procedures which make up the Manufacturer’s Post Market Surveillance system, together with the associated data and reports. For example, annex II of the MDR demands that manufacturers includ… The MDD’s “Design Dossier” has been dropped from the EU MDR. (61) The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field. Last edited by a moderator: Mar 7, 2019. dgrainger. If you need help with MDR transition strategy, gap assessments, or simply getting up to speed quickly on the MDR requirements, check out our MDR training and consulting options. Annex I defines the GSPR “General Safety and Performance Requirements” requirements to establishes conformity with MDR. If you would like to request MDR services from TÜV SÜD, please use this form to register your interest.. Based on the product classification, the manufacturer must apply for an applicable conformity assessment procedure. EU MDR. Finally, it is important to document the decision on the classification and the supporting justification. MDR now provides, in Annex II detailed requirements for the minimum content of technical documentation, together with a specific structure. So if you already have your previous essential requirements, don’t scrap it now. The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this … However, especially manufacturers of high risk devices should be aware that the corresponding documentation will be reviewed with much more attention and scrutiny – compared to low-risk products. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the 'General requirements'. Click here for the latest consolidated text . It only refers to a “clear, organised, readily searchable and unambiguous manner” (MDR annex II). Regulation (EU) 2017/745. Conformity Assessment assessment routes under MDR 2017/745 have not significantly changed under MDR 2017/745 compared to MDD 93/42/EEC however, the timeline to CE marking might now be longer, particularly if there is involvement of expert bodies e.g the MDCG (Medical device co-ordination group). Plus Annex III of the EU MDR requires more than fifteen additional elements in the “Technical Documentation on Post Market Surveillance”. In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following: 6.1. 3.1 Application of the classification rules shall be governed by the intended purpose of the devices. 4.3 Risk management according to ISO 14971: Your risk management activities (plan, analysis, and report) … Requirements regarding design and construction II. The new EU Medical Device Regulation (EU MDR) is not radically different from the current Medical Device Directive (MDD). Devices that are also machinery within the meaning of … If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you … … Powered by TS Q&E - ISO 13485:2016 Medical Device Consulting Services, Please prove you are human by selecting the, Z - Annex (2) II - Technical documentation, 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, results of tests, such as engineering, laboratory, simulated use and, detailed information regarding test design, complete test or study, the clinical evaluation report and its updates and the clinical, the PMCF plan and PMCF evaluation report referred to in Part B of. 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