The MDR defines various documentation requirements, which will be new for all manufacturers, not only for those who produce class III devices. 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 need to know how to comply. The Technical Documentation is to be supplied to Competent Authorities when requested. Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council (1) shall be demonstrated. The Commission shall immediately transmit those documents to the relevant expert panel referred to in Article 106. 178/2002 und der Verordnung (EG) Nr. 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. 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. Annex II of the new EU MDR prescribes more than forty specific elements for the content of the (primary) “Technical Documentation”. Where a device incorporates, as an integral part, a substance which,if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, Where a device is manufactured utilising tissues or cells of human, In the case of devices that are composed of substances or, In the case of devices containing CMR or endocrine-disrupting, In the case of devices placed on the market in a sterile or defined, In the case of devices placed on the market with a measuring, If the device is to be connected to other device(s) in order to operate as intended, a description of this combination/configuration. This will provide a high … (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). 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 Under the EU MDR, Notified Bodies issue an EU quality management system certificate according to Annex IX of Regulation (EU) 2017/745. ANNEX II. Harmonised standards / common specifications (Articles 8 and 9 of the MDR and IVDR) Please see Annex IX, X and XI of the MDR and the IVDR for more information. In the opinion of the author, the Technical Documentation is one topic which can and should be addressed by Manufacturers without delay. Thank you for your question. 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 … There are some differences in the wording and also some new requirements. Class IIa (medium risk) Class IIb (medium/high risk) Class III (high risk) Device Classification rules The MDD contained 18 rules for classification. Devices that are also machinery within the meaning of … Finally, it is important to document the decision on the classification and the supporting justification. Mar 8, 2019 #14. 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. Please prove you are human by selecting the Car. Last edited by a moderator: Mar 7, 2019. dgrainger. Therefore, medical device manufacturers shall use this annex to ensure compliance with the new regulation. 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. 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. Technical documentation (Annex II of the MDR and IVDR) 3. 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. MassimoP Z - Annex (2) II - Technical documentation annex, ANNEX II, mdr, technical documentation ANNEX II (PART 2) Technical documentation. 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. 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. Luckily, the requirement on quality management systems has been clarified in article 10, and now contains a list of things that must be addressed. Introduction Definitions Classification Conformity assessment UDI and Eudamed Supply chain obligations PMS and vigilance Contact 14 Placing a device on the market … Regulation (EU) 2017/745. 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. We offer an easy and low-cost software solution to manage UDI and communicate with EUDAMED. MassimoP Z - Annex (2) II - Technical documentation annex, ANNEX II, mdr, technical documentation ANNEX II (PART 1) Technical documentation. Implementing rules. Trusted Information Resource. The new EU Medical Device Regulation (EU MDR) is not radically different from the current Medical Device Directive (MDD). Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. Annex II: Technical documentation; pre-clinical and clinical evaluations. Common specifi… 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. In contrast to the MDD, the new EU MDR is consistent throughout on the subject of the Technical Documentation. Those rules can be found in Annex IX of the MDD. 6. MDR Application Procedure. 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. 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). Device description. TECHNICAL DOCUMENTATION. That’s not to underestimate the amount of work that will be required to switch from the current MDD to the new EU MDR. Article 10 of the EU MDR makes the creation and maintenance of both parts of the Technical Documentation an obligation of all Manufacturers. Plus Annex III of the EU MDR requires more than fifteen additional elements in the “Technical Documentation on Post Market Surveillance”. In this first section, you need to introduce your device. Yes: ☐ 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. (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. EU MDR. Regardless of when the first Notified Bodies will be designated, or when the UDI structure will be decided, or even when the EUDAMED database will be available. 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. MDR Application Procedure. Table – Conformity Assessment Options Device Class Conformity Assessment Procedure Class […] 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 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. You can still upgrade them to the GSPR that you can find on annex I of MDR … The MDD’s “Design Dossier” has been dropped from the EU MDR. 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. Try it now for free! Don't forget that you need to also check the machinery directive as per Article 1.12: 12. The European Union Medical Device Regulation of 2017. It only refers to a “clear, organised, readily searchable and unambiguous manner” (MDR annex II). 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 … MassimoP Z - Annex (2) II - Technical documentation annex, ANNEX II, mdr, technical documentation ANNEX II (PART 1) Technical documentation. … For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory. Meaning that, eventually, every technical documentation has the same form of content, but as far as the general structure or the … 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. 3.2. 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. The Technical Documentation is going to be needed at some point for all devices. CHAPTER II. 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. Click here for the latest consolidated text . EU Medical Device Regulation (MDR 2017/745) Annex II In addition to the specific requirements identified within Annex I of the EU MDR, Annex II – Technical Documentation identifies additional requirements. In the absence of such studies, a justification shall be provided. In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following: 6.1. The European Union Medical Device Regulation of 2017. April 2017. über Medizinprodukte, zur Änderung der Richtlinie 2001/83/EG, der Verordnung (EG) Nr. VERORDNUNG (EU) 2017/745 DES EUROPÄISCHEN PARLAMENTS UND DES RATES. TÜV SÜD has developed an online service registration form to allow us to systematically process your request. 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. So if you already have your previous essential requirements, don’t scrap it now. MDR Resource Center The knowledge you need for MDR implementation. 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. Plus Annex III of the EU MDR requires more than fifteen additional elements in the “Technical Documentation on Post Market Surveillance”. PRODUCT VERIFICATION AND VALIDATION. MEDDEV recommendations are incorporated into the MDR in article 61 and annex XIV including requirements related to equivalent devices. Mar 8, 2019 #14. 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). Die technische Dokumentation enthält die in den Anhängen II und III aufgeführten Elemente. 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. vom 5. Unfortunately, this question has to be answered with a “no”. (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 I defines the GSPR “General Safety and Performance Requirements” requirements to establishes conformity with MDR. 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. Specifically, Section 4 – General Safety and Performance Requirements states: Technical file update according to Annex II and III. MDR 2017 / 745 Annex II Medical Device Technical File is a summary document prepared by … Particular attention must be paid to: 7. This guidance provides information on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). 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 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; 1223/2009 und zur Aufhebung der Richtlinien 90/385/EWG und 93/42/EWG des Rates category of devices (for Class IIa and Class B) prior to issuing the certificate. With the MDR, the rules are expanded. 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? 4.3 Risk management according to ISO 14971: Your risk management activities (plan, analysis, and report) … 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. 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'. There are now 22 rules in Annex VIII of the MDR. Requirements regarding design and construction II. Chemical, physical and biological properties 7.1. The Technical Documentation required by the current Medical Device Directive (MDD) is largely left to the Manufacturer’s discretion. 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. A copy is also to be kept by Authorised Representatives (EU MDR Article 11). Annex II Technical File Documentation. All Annex 4/IV certificates issued before the MDR came into force will become invalid by May 27, 2022, at the latest. ANNEX II. 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. Additional information required in specific cases. For example, annex II of the MDR demands that manufacturers includ… 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 … 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. Requirements regarding design and manufacturing 7. 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. No special regulations apply for certificates according to Annex 4/IV issued after the MDR came into force. The MDD’s “Design Dossier” has been dropped from the EU MDR. Requirements Evidence of the biological safety of a medical device Providing this evidence is facilitated if biocompatible (raw) materials are used. 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 Regulation and in particular the applicable general safety and performance requirements. Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. TÜV SÜD has developed an online service registration form to allow us to systematically process your request. and Annex XIII II. (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 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. Please see below for example or explanation for EU MDR Technical Documentation. Absent 7.4 - consultation text 10 - consultation text MDR Annex IX, Chapter II, Section 5.2 Please note: This document is a guide to help you to map the changes for the MDR. There is also mention of a “Design Dossier” in MDD Annex II but this is not further defined in the MDD. 3.1 Application of the classification rules shall be governed by the intended purpose of the devices. MDR now provides, in Annex II detailed requirements for the minimum content of technical documentation, together with a specific structure. Regulation (EU) 2017/745. Class III devices: The current MDD’s Annex II “full quality assurance” route will be replaced the new EU MDR’s Annex IX “conformity assessment based on quality management system assurance and assessment of the technical documentation”. However, it is likely that these certificates will also have a limited period of validity. GSPR is replacing the Essential Requirements that were on the MDD Annex I. (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 … (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.) Annex II of the new EU MDR prescribes more than forty specific elements for the content of the (primary) “Technical Documentation”. Under the EU MDR, Notified Bodies issue an EU quality management system certificate according to Annex IX of Regulation (EU) 2017/745. 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). 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.