Common specifications eu mdr (EU) 2023/1194 – June 2023: - Transitional provisions for Annex XVI devices 4. Annex XIV of the EU MDR defines the requirements for the clinical evaluation process. Article 9 only allows for an exemption if manufacturers “can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto”. Click here for the list of impacted devices and the link to provide feedback. Click here for the update. The relationship between harmonised European standards and EU legislation: the “Annex Z” 3. See full list on casusconsulting. ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process, or system. The MDR defines common specifications as: Jul 23, 2024 · In December 2022, four and a half years after the MDR was published, the EU released two Commission Implementing Regulations. (EU) 2020/1207, containing the common specifications for the reprocessing of single-use devices. Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. 2(71) and IVDR Art. The necessary common specifications shall be adopted by 26 May 2020. But are you obliged to use them? CS ‘common specifications’ as defined in the MDR5 EU European Union Eudamed European database on medical devices FSCA field safety corrective action6 FSN field safety notice7 1 MDR, Article 32 (1) 2 MDR, Article 32 (2)(f) , Article 61 (11) and Article 83 (3)(d) 3 MDR, Recital (43) 4 MDR, Article 18 5 MDR, Article 2 (71) 6 MDR, Article 2 (68) Sep 22, 2021 · The EU MDR Commission perceives itself to be entitled to implement common technical specifications where no harmonized standards exist or where they are not sufficient. The MDR is applicable to Annex XVI products as from the date of application of the CS that cover a product or a group of products. The European Medical Devices Regulation (EU MDR) is now in full effect (as of May 26, 2021), which impacts any medical device manufacturer with plans to get devices approved in the EU as well as manufacturers with existing products on the market. Sep 22, 2021 · Compliance with common specifications of EU MDR. Harmonised European standards in support of the EU legislation on medical devices 3. Voluntary use of standards 2. Raghavendra_javvaji Registered. 2. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications Nov 9, 2020 · This is what we will review within this episode with Stefan Bolleininger. Use of Harmonised Standards. Jun 22, 2023 · Common Specifications: Commission Implementing Regulation (EU) 2022/2346 in EU Official Journal (EN) Classification: Commission Implementing Regulation (EU) 2022/2347 on the reclassification of rules 9 and 10 for Annex XVI devices (EN) Harmonised standards under the Regulations on medical devices and in vitro diagnostic medical devices are developed by CEN and CENELEC as European standardisation organisations, on the basis of a standardisation request issued by the Commission according to Regulation (EU) No 1025/2012. The European Commission expects to adopt the Common Specifications for the groups of products listed in Annex XVI in the third quarter of 2022. • Common specifications in accordance with Regulation (EU) 2017/746 (for Class D devices) (Q2 2022)* • Commission Implementing Regulation (EU) 2022/944 on tasks and criteria for the EURLs (Q3 2022)* • Commission Implementing Regulation (EU) 2022/945 on fees that the EURLs may levy from notified bodies and Member States (Q3 2022)* The “Common Specifications” referred to in the EUMDR and EUIVDR, once they have been agreed, are published via implementing regulations. Products affected by these common specifications are described in Annex XVI and include: Oct 21, 2022 · The European Commission has adopted common specifications under Annex XVI of the Medical Devices Regulation (MDR) in a much-anticipated vote. 8 •Applicable standards, Common Article 9: Common specifications. As we move towards the E. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications Medical Devices. (23) Directive 98/79/EC of the European Parliament and of the Council 16 allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices. The use of harmonised standards is defined in the Article 8 of the EU MDR 2017/745. The concept of common specifications is explained in the Mar 14, 2023 · Purpose of Common Specifications. europa. COMMISSION IMPLEMENTING REGULATION (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. A common specification is a standard that has been created based on an initiative from the EU, and not through the regular standardisation process from ISO and IEC. Transitional periods were introduced for certain Annex XVI products. Jul 4, 2019 · The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety. Feb 19, 2021 Everything a Medical Device Manufacturer Needs to Know About Post-Market Clinical Follow-up. What are Common Specifications? Common Specifications (CS) are a set of technical and/or clinical requirements, other than a standard, that provide a means of conforming to the legal obligations applicable to a device, process, or system. Manufacturers of these products sold in Europe and Northern Ireland will have to comply with the relevant requirements laid out in the MDR for general medical devices to ensure user safety, including compliance with Common Specifications (CS). What are Common Specifications? The definition of common specifications according to the EU MDR and IVDR is “ set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system”. In the European Union, under the Medical Devices Regulation (MDR) and the In Nov 16, 2020 · 對於 MDR 法規架構下的新朋友 "Common Specifications (CS)"，身為製造商我需要知道些什麼？ 大家可以將 CS 看成，MDR在建立法規條文時，因為太多東西還無法在那時寫進來（因為還沒搞清楚）所以幫自己留了一處讓以後可以郎無限擴充的法規雲端空間。 Jan 16, 2023 · The common specifications laid down in this Regulation cover the requirements set out in the second sentence of Section 1 and in Sections 2 to 5, 8 and 9 of Annex I to Regulation (EU) 2017/745. Jun 3, 2023 · EU MDR was meant to apply to Annex XVI products from the date of application of the Common Specifications (CS), which were published in December 2022 in Regulation (EU) No. Common specifications. 14. MDCG 2021-11 Guidance on Implant Card – Device types. ’ Reference Title Publication; Gradual roll out of EUDAMED : Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and Oct 22, 2018 · By Marcelo Trevino, independent expert. Class IIa medical devices are subject to the same common specifications and PMS requirements as Class I medical devices. ”1 Essentially, the European Commission has reserved the right within both EU MDR1 and EU IVDR5 […] Feb 4, 2022 · The Common Specifications are intended to provide a set of technical and clinical requirements on the basis of which conformity with the requirements of the MDR can be demonstrated. Article 9. Nov 9, 2020 · IMDb is the world's most popular and authoritative source for movie, TV and celebrity content. With this, CS become very strict and a regulatory requirement with little room for alternatives. 1. (EU) 2022/2347 – December 2022: - Reclassification of certain active products 3. 1. Note that this is not the final, complete file as it is missing specifications for each category of Annex XVI. EU Directives, such as the MDD and IVDD, as well as EU Regulations, such as the MDR and IVDR impose so-called general requirements on all medical devices must meet. The Medical Devices Regulation (MDR) introduces a new concept alongside harmonized standards, called Common Specifications (CS). The certified device – a hyaluronic acid based dermal filler – is covered by group 3 of Annex XVI and fulfils the strict requirements of MDR and the Common Specifications 2022/2346. Jan 22, 2024 · The pathway for Class IIa medical devices within the EU MDR comprehends the Common Specifications, PMS, Periodic Safety Update Report (PSUR), EU declaration of conformity, and CE marking. Thread starter Raghavendra_javvaji; Start date Feb 19, 2021; R. These implementing regulations cover Common Specifications for all Annex XVI devices and classification requirements around active Annex XVI products. Mar 17, 2023 · Annex XVI of the MDR EU 2017/745 lists products (6 categories) without an intended medical purpose that now fall under the MDR. A cornerstone of this regulation is to write and maintain the required technical documentation, often referred to as the Technical File. MDCG 2023-5 . 2 (74). May 21, 2021 · Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and Jul 5, 2022 · This Regulation lays down common specifications for certain class D in vitro diagnostic medical devices in respect of the requirements regarding the performance characteristics set out in Section 9. Manufacturers must comply with Common Specifications (CS) as defined in EU MDR. First, it is stated that European standard published in the Official Journal of the European Union shall be presumed to be in compliance with the EU MDR or IVDR; for this reason this standard can be used as method to demonstrate compliance to this regulation. COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1207 of 19 August 2020 laying down r ules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specif ications for the reprocessing of single-use devices (Text with EEA relevance) THE EUROPEAN COMMISSION, The EU MDR entered into application on 26 May 2021. This will depend on the position of the Member State; although the CS provide examples of SUDs that could be considered unsuitable for reprocessing2. The Annex XVI common specifications cover products with no intended medical purpose that fall under the scope of the MDR. Feb 20, 2023 · The EU MDR defines common specifications as “a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system”. What is European Union (EU) Medical Device Regulation (MDR) Published in the Official Journal of the European Union in April 2017, the European Union’s (EU) Medical Device Regulation (Regulation (EU) 2017/745) was developed to reflect the significant progress in medical device technologies that had taken place since the implementation of the EU’s initial framework in the 1990s, and to Mar 4, 2022 · A draft of common specifications for Class D devices has been published by the European Commission. This helps to establish requirements for Class D devices with no harmonised standards. In a significant development for the Medical Device Regulation (MDR) landscape, the adoption of the Common Specifications within the Commission Implementing Regulations 2022/2346 and 2022/2347 on 1 st of December 2022 marks a pivotal milestone. ’s Medical Device Regulations (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746) — MDR and IVDR, respectively — the technical committees are in the process of determining necessary changes to the European Harmonized standards, including the incorporation of the new Annex ZA/ZZ. Common specifications are detailed practical rules setting out how particular types of devices should comply with certain requirements of Regulation (EU) 2017/746 IVD expert panel The expert panel is one of the independent scientific bodies established by the Regulations on medical devices and Commission Implementing Decision 2019/1396 Neither the EU Medical Device Regulation (MDR)1 nor the European Commission Common Specifications (CS)2 include a specific list of devices prohibited from reprocessing. 1 Guidance on cybersecurity for medical devices. These devices demonstrate conformance based on sufficient clinical data and applicable Common Specifications (CS) or are of a specific family per Article 61(6). 7/1 guidance: planning, data collection, data appraisal, data generation (if indicated), data analysis and conclusions, Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general Class I Guidance MDCG MSWG - MDCG 2019-15 rev1 5 Foreword These guidance notes do not aim to be a definitive interpretation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) and are intended for The Common Specifications are intended to provide a set of technical and clinical requirements on the basis of which conformity with the requirements of the MDR can be demonstrated. Under the new MDR, such a “recycler” is considered a manufacturer and must therefore comply with both the regulation requirements and applicable national mandates. The European Commission on Monday issued a regulation that establishes common specifications certain high-risk in vitro diagnostics (IVD), which are a critical component of the In Vitro Diagnostic Regulation (IVDR). 4. In the EU MDR and IVDR, Common Specification is mentioned and it is a tool that the EU Commission can use. Main references 2. Find ratings and reviews for the newest movie and TV shows. 3. 1 published, 1 under draft, and some that are supposedly planned. MDCG guidance documents are not “Common Specifications” but guidance from the EU’s medical device experts on subjects which require interpretation or clarification. Important information includes: - Information related to the timeline - Annexes for each category (but little/no information) Jan 17, 2020 · Just read up on this subject and wanted to add that the Common Specifications can be found on the official website for EU laws, see: eur-lex. MDR Annex XVI devices: EU requirements Aug 19, 2020 · 適用的調和標準 (Harmonised standards) 或共通規則 (Common specification, CS) 變更時， 可以及時地持續符合 MDR 的要求。 MDR 在 Article 10 的第 9 項中列出以下 13 點，為品質管理系統必須處理的要素，需建立相關程序或規範： (a) 符合性評鑑程序 & 變更管制程序 Dec 14, 2022 · Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022, laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (MDR) and Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of the MDR as regards reclassification of groups of certain Directive 98/79/EC of the European Parliament and of the Council (16) allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices. The common specifications laid down in Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the on the European market in accordance with the AIMDD and MDD. 2022/L 311/60 (December 2, 2022) 2023/2459 (November 1st, 2023) Apr 24, 2020 · The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety. MDCG 2019-16 Rev. Title of the standard EN 285:2006+A2:2009 Sterilization – Steam sterilizers – Large sterilizers EN 455-1:2000 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes […] MDR Requirements for technical documentation 1: Device description EU or elsewhere . Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of this Regulation (‘MDCG’), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of MDCG 2021-8 Annex 6 Checklist of general safety and performance requirements, Standards, common specifications and scientific advice. The European Commission can adopt common specifications where. Jul 5, 2019 · Article 9. Medical Device Coordination Group Document. In addition to Common Specifications, the MDR introduces clinical Jun 5, 2020 · providing advice to EU countries, manufacturers and notified bodies on various scientific and technical matters; contributing to the development and maintenance of relevant guidance documents, common specifications and international standards; providing opinions in response to consultations from manufacturers, EU countries and notified bodies Aug 19, 2024 · The EC is proposing to add new Class D common specifications to Implementing Regulation (EU) 2022/1107. Common Specifications BSI could not certify Annex XVI Devices until publication of CS Implementing Regulations 1. The necessary common specifications shall be adopted by M1 26 May 2021 . Jun 14, 2024 · The MDR demands that such products comply also with the requirements listed in the relevant Common Specifications, issued by the European Commission. The Annex XVI of the MDR EU 2017/745 lists products (6 2. 1 Guidance on standardisation for medical devices. This Regulation lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745. But are you obliged to use them? In this episode, we will talk about a few common specifications. Sep 1, 2023 · Adopted in 2017, the EU Medical Device Regulation (MDR) brought a host of changes. Dec 6, 2022 · Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices Common Specifications (CS) has been established in MDR Article 9. Commission Implementing Regulation (EU) 2022/2346, as amended by Implementing Regulation (EU) 2023/1194, lays down common specifications (CS) for the groups of products without an intended medical purpose listed in Annex XVI to the MDR. U. Dead Serious! On December 01, 2022, the European Commission published common specification for the group of products listed under Annex XVI of EU Medical Device Regulation – EU MDR as ‘products without an intended medical purpose. Indeed, according to the MDR1, “the common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation Manufacturers of these products manufactured in European Union incl. Contracting for Reprocessing Sep 3, 2024 · The MDR and IVDR introduce the concept of “common specifications” as an alternative means of complying with legal obligations when harmonised standards are not available or sufficient. MDCG 2021-5 Rev. Jan 18, 2024 · Unraveling the New Common Specifications for Annex XVI Devices: 2022/2346 and 2022/2347. Jan 27, 2022 · The #EC has published a draft version of the Annex XVI Common Specification (in English). Oct 15, 2024 · New standards have been harmonized under the EU MDR/IVDR. 4, point (a), of Annex I to Regulation (EU) 2017/746. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the Feb 19, 2021 · EU-MDR Article 9-common specifications. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746) 2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”). Dec 2, 2022 · Final text of Medical Device Common Specifications for Annex XVI Published. com Dec 2, 2022 · Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance) Common Specifications are to be adhered to unless otherwise proven that the alternative fulfills the safety and effectiveness level, as demanded in article 9 of the MDR and IVDR. Sep 9, 2020 · In order to harmonise the above procedures, a Common Specification which has recently been adopted by the Commission via an implementing regulation (Commission Implementing Regulation (EU) 2020/1207) sets specific requirements and procedures to be followed in terms of Quality Management Systems, labelling, traceability, vigilance, staff Dec 2, 2022 · The official journal of the European Union now includes two Commission Implementing Regulations on Annex XVI of the Medical Devices Regulation 2017/745 (MDR). Nov 9, 2023 · The Notified Body TÜV SÜD Product Service GmbH released the first certificate for a non-medical purpose device according to Annex XVI of Regulation (EU) 2017/745. The European Commission has recently published the final text of the common specifications for medical devices without Feb 27, 2023 · The quick answer to this question is a Common Specification (CS): “means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system. Common specifications for products without a medical purpose Articles 1(2) and 9(1) MDR: Commission implementing act Common specifications (CS) addressing for any of the groups of products listed in Annex XVI of the MDR, at least, application of risk management as set out in Annex I and, where necessary, clinical evaluation regarding safety. (EU) 2022/2346 – December 2022: - Common Specifications 2. There you can find them by searching for "Commission Implementing Regulation" in combination with the regulation which it falls under (so for instance "Regulation (EU) 2017/745" for the MDR). Annex I lays down common specifications for all those groups of products without an intended medical purpose. MDCG Guidance 2023-5 provides further insights on these products, with guidelines and examples on classification of Annex XVI devices. Plus, a link to a consolidated list of all Harmonized Standards and Common Specifications. In areas where no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications May 24, 2021 · The definition of common specifications according to the EU MDR and IVDR is “ set of technical and/or clinical requirements, other than a standard, that List of Harmonized Standards Below the list of harmonized standards for medical device for your reference and search For latest update check the official page. 5 Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices – Sep 26, 2024 · If you plan to develop and sell a medical device on the European Market, complying with the MDR (European Union Medical Device Regulation (EU MDR 2017/745)) is mandatory. As of February 23, 2023, the European Commission has published three implementing regulations that lay down common specifications for:- certain Class D in vi By EU MDR standards we also mean common specifications. 2022/2346. Article 9: Common specifications. Amongst the many tasks assigned to the Medical Device Coordination Group (MDCG) in the Article 105, one task is to contribute to the development of standards, common Dec 5, 2022 · EU MDR is getting serious. These are included in the In Vitro Diagnostic Medical Devices (IVD) Directive where they were called Common Technical Specifications and were for Annex II List A products. The first of these regulations states common specifications for groups of products without an intended medical purpose , whereas the second lays down the rules for the reclassification of Jul 20, 2022 · A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications Sep 1, 2020 · On 20 August 2020, the European Commission issued regulations establishing Common Specifications for the reprocessing of single-use medical devices (SUDs) under the Medical Devices Regulation (MDR) (the “Common Specifications”). These are largely consistent with the process as described under EU AIMDD and EU MDD and expanded in the MedDev 2. Annex I lays down common specifications for all those groups of products without an intended medical pur pose. (CS will be developed by the European Commission after consulting the MDCG and stakeholders. Jun 28, 2023 · What is the EU MDR Annex XVI / common specifications? Regulation (EU) 2017/745 on Medical Devices, known as the Medical Devices Regulation (MDR), came into force in May 2021. of . This Regulation lays down common specif ications for the groups of products without an intended medical pur pose listed in Annex XVI to Regulation (EU) 2017/745. In its Annex XVI, for example, the regulation expands its scope to take in new product groups referred to as “products without an intended medical purpose”—in other words, items or devices used for aesthetic indications, such as colored contact lenses or equipment for laser skin treatments. These specifications are legally mandated in specific cases, such as for products without an intended medical purpose and the reprocessing of single-use devices. 2. Jan 16, 2024 · Common specifications are closely related to General Safety and Performance Requirements. Northern Ireland will have to comply with the relevant requirements laid out in the MDR for general medical devices to ensure user safety, including compliance with the relevant Common Specifications ((EU) 2022/2346). Page . Next Steps. Feb 22, 2024 · Common specifications are detailed practical rules setting out how particular types of devices should comply with certain requirements of Regulation (EU) 2017/746. 4 MDR, Annex XIV, Part A (3). Get personalized recommendations, and learn where to watch across hundreds of streaming providers. 5. For businesses, this regulation introduces a complex array of new requirements aimed at ensuring that medical devices meet the highest safety standards before they reach the market. eu . In areas where no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications Apr 10, 2023 · Common specifications (CS) are not standards, harmonized or otherwise, although their purpose is basically the same: they consist of technical and/or clinical requirements that provide a means of complying with the legal obligations applicable to a device, process or system, per the definitions in EU MDR Art. Oct 31, 2024 · The European Union Medical Device Regulation (EU MDR) was established to reinforce the safety and efficacy of medical devices marketed within the EU. The EU Commission has yet to define common specifications on this topic. It replaced the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC, (AIMDD). 1, points (a) and (b), Section 9. The general framework for harmonised European standards 2. Dec 6, 2022 · Regulation 2022/2346 is intended to fulfill the requirements of the MDR for common specifications for devices without a medical purpose addressing, “at least, application of risk management as set out in the general safety and performance requirements laid down in Annex I to that Regulation and, where necessary, clinical evaluation regarding Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices (Text with EEA relevance) What are Common Specifications? Is this the same as ISO standards or any other guidance? This is what we will review within this episode with Stefan Bolleininger. Common Specifications are a set of technical and/or clinical requirements, other than a standard, that provide a (1) For certain class D in vitro diagnostic medical devices falling within the scope of Regulation (EU) 2017/746, harmonised standards do not exist as regards certain requirements of Annex I to that Regulation, and there is a need to address public health concerns as the risk associated with the use of those devices is significant for public health and patient safety. Aug 21, 2020 · The European Commission this week issued regulations establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). 3 and Section 9. . siis jax xzdsl xvy few plo zycud xjfc jlm srvv