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Notified body medical devices Notified Bodies in Germany. 2022) internal Link: List of identification numbers of Notified Bodies under § 15 Medical Devices Act: PDF General Medical Devices; Active Implantable Medical Devices; In-vitro Diagnostic Medical Devices; BSI dual designation facilitates the certification process for your medical devices and IVDs, saving you from managing your product portfolio certification activities among different Notified Bodies and UK Approved Bodies. Table: Responsibilities and roles of Notified Bodies according to the EU Medical Device Regulation (2017/745) CHAPTER I – SCOPE AND DEFINITIONS Notified Body means a conformity assessment body designated in accordance with REGULATION (EU) 2017/745 as per Art. Help us keep this information up to date. Class II, Class III and some Class I devices will require the approval of a Notified Body. Notified bodies for medical devices are independent organizations appointed by EU member states to assess the conformity of certain products before they are placed on the market. It also makes sure that requirements are met as long as the product remains on the market. Your organization wishes to get CE Marking for your medical device(s), according to Medical Device Regulation (EU) 2017/745. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions impose Mar 25, 2024 · What is a Notified Body? Notified bodies are looking for compliance not non-conformities. 2018 The notified bodies registered with CDSCO under provisions Medical Devices Rules Nov 30, 2021 · We are pleased to confirm that our Belgian Notified Body has been designated by the European Commission and Belgian Competent Authority (FAMHP) under Medical Device Regulation (EU) 2017/745. 2017 under Drugs and Cosmetic Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are effective from 01. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates. These bodies carry out conformity assessment procedures for all devices classified outside the lowest risk classification. 78 (E) dated 31 01. Kiwa Cermet Italia (NB 0476) in Italy, Kiwa Belgelenddirme Hizmetleri (NB 1984) in Turkey, and Dare Services (NB 1912) in The Netherlands, are the Notified Bodies within the Kiwa Group, boasting a wide and in-depth experience in medical devices certification, with thousands of products already certified. 2017/745 on Medical Devices (MDR). Location: Harbor City, California. third-party sterilization, repackaging). EU Notified Bodies designated under the EU MDR (2017/745) Nando (New Approach Notified and Designated Organisations) Information System; NANDO - Notified Bodies for active implantable medical devices (90/385/EEC) Notified Bodies for medical devices (93/42/EEC) Notified Bodies for medical devices (MDR) Notified Bodies for in vitro diagnostic medical devices (98/79/EC) Intertek Medical Notified Body UK Ltd (IMNB UK Ltd) has been designated against the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) by the Medicines and Healthcare products Regulatory Agency (MHRA). Notified Bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs). R. For example, a notified body may designate that a medical device conforms to the essential requirements of the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical devices. Mar 2009 NBOG BPG 2009-2: Role of Notified Bodies in the Medical Device Vigilance System NSAI is a leading Notified Body for medical device certification services. If a notified body is involved, it is the notified body that “grants” the CE marking for the A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. Nov 21, 2024 · Under the EU MDR and IVDR, Notified Bodies are required not only in the conformity assessment of medical devices and IVDs that are not low-risk devices, but also in the certification of certain processes that are not conducted by the manufacturer (e. risk) devices, a Notified Body audits the manufacturer’s quality system and the manufacturer requires a favourable audit to proceed to CE marking. Jan 26, 2023 · List of Notified Bodies: Download. The Designating Authority is a body which has the authorisation to designate and controll the notified bodies located in Hungary. The notification, that was published on the 20th of August in the European NANDO system, allows IMQ to support right now medical device manufacturers in getting certification under the new MDR allow continued availability of safe medical devices to the market and assist in the prevention of the risk of medical device shortages. Indian Certification of Medical Devices Scheme (ICMED) Intertek Medical Notified Body | Choosing the Right Notified Body; ISO 13485 | Quality Management Systems for Medical Devices; ISO 22716 | Good Manufacturing Practices for Cosmetics; MDR 2017/745 | EU Medical Device Regulation; Medical Device Single Audit Program (MDSAP) 44 Notified Body Medical Device Auditor jobs available on Indeed. In this context, it is considered that alternative solutions to carrying out on-site audits by notified bodies under the medical devices Directives1 should be allowed under specific circumstances,. Our aim is to make sure that medical devices are as safe as possible and that they work as intended. The "Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)" is responsible for designation and monitoring of the Notified bodies in Germany. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. For more details click below links: List of 13 Notified Bodies registered with CDSCO under MDR 2017 as on 03-04-2023. Apply to Auditor, Certification Manager, Director of Education and more! As a Notified Body with the identification number 0124, DEKRA Certification GmbH accompanies conformity assessment procedures for medical devices in accordance with Directive 93/42/EEC, Regulations (EU) 2017/745 and (EU) 2017/746 for companies placing medical devices on the market. Feb 5, 2024 · What is a notified body? In the context of the Medical Devices Regulation, a notified body is an independent organisation selected by an EU member state to assess whether the medical device fulfils the requirements of the Medical Devices Regulation. 33(4) (Independence) 33(9) (professional integrity) and 33 (10) (sufficient internal competence of personnel in AI) and all this should have been assessed when the Notified Body got the designation under the MDR. in 2013 Clinical Health Technologies (CHT) is a full-service product development organization focused on our guiding principles in efficacy and safety empowering us to create unique products with the highest standards in compliance and Notified Body and UK Approved Body lead times BSI is a full scope Notified Body and UK Approved Body and can accept and certify all types of medical devices and in-vitro diagnostic medical devices (IVDs). The designation of a notified body is based upon the competency within the notified body. On this page you will find information about the basic requirements and legislation for medical devices in the EU, and the services that SGS can provide with its Notified Bodies NB 0598 / SGS Fimko and NB 1639 / SGS Belgium. Instead, some Notified Bodies will be designated to do conformity assessment of other items such as toys, communication devices or construction products that have other regulation/directive. o. Notified Body & Certification Body in the Health Care and Medical Devices Industry Whether part of a voluntary certification process or within a regulatory framework, we combine your various certification needs for maximum efficiency, addressing the conformity and quality challenges you face. 6, 70191 Stuttgart, Germany), a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number 0483 on Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment Note: Please note that the current scope expressions (MD / MDS codes) can be found in the respective notification forms below. www. Notified bodies are not permitted to consult. The ZLG publishes the Notified Bodies on their website according to the EU regulations (MDR and IVDR). MDR Designated Notified Body; C heck Nando status about the current notified bodies designated for MDR ISO 13485:2016 Medical Device Consulting Services Mar 25, 2024 · How does a notified body become designated? A notified body is designated by a Joint Assessment Team (JAT) -Usually the EU Commission and 2 - 3 Member states. Previous Notified body for manufacturers of medical devices | CE marking under Regulation (EU) 2017/745 & QM certification according to QM standards NSAI is a designated Notified Body under the Medical Device Regulation 2017/745. Email: UKCAmedicalAB0120@sgs. The term medical devices also includes in vitro diagnostics. Central Govt. Where products require additional expertise the BSI Notified Body has a number of teams covering all medical devices, including vascular, orthopaedic and dental, sterile products, IVD, medicinal substances, products utilizing animal tissue, active implantable devices, woundcare, ophthalmic and others. Medical devices are divided into different risk classes, as indicated in the MDR. Conformity assessment is the systematic process of evaluating Medical Devices Product Certificatio ns: SIGNIFICANT CHANGES A HEAD FOR MEDICAL DEVICE / IN VITRODIAGNOSTICS DEVICE MANUFACTURERS On March 15, 2023, a new Skip to content certification@zenith-worldwide. 05. The members are Notified Bodies under any or all of the three medical device directives: 90/385/EEC; 93/42/EEC; 98/79/EC. Medical Device Regulation (MDR) The Medical Devices Regulation (EU) 2017/745 (MDR) applies to medical devices and their accessories. A designated body (Swiss term) is the same as a notified body (EU term). They are an indispensable part of the regulatory system since they grant a CE mark to each device before it can be placed in the EU market. Notified Bodies are undergoing a significant revamp in order to comply with their greater obligations according to Overview of notified bodies for medical devices. 1. Job Title: Quality Assurance Manager – ISO 22716 & cGMP. SGS is a Medical Device Notified Body for your range of products and certification will be undertaken as Notified Body 1639 for SGS Belgium NV. ISO 13485 Management System for Medical Devices. Jul 1, 2023 · From 1 January 2021, to place a CE mark on a medical device for circulation in both Northern Ireland and the EU, manufacturers must use an EU-recognised notified body to undertake any mandatory A notified body (NB) is an organization in charge of the conformity assessment of medical devices before they are placed on the market or put into service. Apply to Monitor, Regulatory Affairs Specialist, Regulatory Specialist and more! When a medical device is of higher risk class than class I, conformity to regulations must be assessed by a Notified Body. List of Notified Bodies – Directive 93/42/EEC on medical devices (status as of 25. Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification: Nov 8, 2021 · The European Commission publishes a list of recognized notified bodies that can legally perform conformity assessment audits on medical devices. List of Notified Bodies by ZLG Online System for Medical Devices Central Drugs Standard Control Organisation Directorate General Of Health Services Approved Notified body. Our experts deliver a wide range of standard and non-standard tests on medical devices and certify them through our notified bodies. 178/2002 and Regulation (EC) No. Apr 27, 2023 · 1. Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) July 2021: MDCG 2021-15: Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR 68 Eu Mdr Notified Body Medical Devices jobs available on Indeed. com. Notified bodies will submit their advice request in cooperation with the orphan device manufacturer. doc The purpose of this Recommendation is to provide guidance to Notified Bodies, For the certification of medical devices, the Italian National Institute of Health was notified by the Italian Government to the European Commission on 14/02/1995 and obtained the renewal of the designation on 5/7/2017; the notification concerned the designation to carry out certification tasks in Italy and specifically the CE certification Jun 27, 2023 · A notified body is an organisation which has been designated/granted authority by the national health authorities to review the manufacturers’ technical documentation and assess if the medical device meets the statutory requirements prior to the certification of the medical device. Play We have full scope with more than 100 product categories, including: Team-NB is the European Association of Notified Bodies active in the Medical device sector. Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority (‘authority responsible for notified bodies’), which may consist of separate constituent entities under Jan 12, 2024 · Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. Designated bodies verify medical devices’ compliance with legal requirements. If the devices meet the requirements, they can be admitted to the European market and be CE marked. A coordination group of notified bodies in the field of medical devices (NBCG-Med) is established in accordance with Article 49 of Regulation (EU) 2017/745 on medical devices and Article 45 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Notified Bodies serve as essential gatekeepers in the medical device industry, working closely with manufacturers to ensure compliance through several activities: Conformity Assessment for High-Risk Devices. As Notified Bodies are officially designated, we will add them here. Jan 12, 2024 · Preparing for a Notified Body Medical Device Clinical Audit Public speaking. Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices: A notified body accredited by National Accreditation Body( designated by Central Government) may apply in MD 1 to CLA for grant of registration certificate in MD 2. Read More . Notified bodies are involved before placement of medical devices on the market, except for Class I medical devices, custom-made devices and in-vitro diagnostic medical devices, other than included in Annex II to Directive IVD. We review your medical devices and IVDs to assess conformity against European Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to market. A Notified Body is an independent organization designated by an EU Member State to make sure that the Medical Device Requirements (MDR) and In Vitro Diagnostic Requirements (IVDR) are being followed for as long as the product remains on the market. 2. Notified bodies cannot provide the answer for manufacturers. A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) Authorized to act under European Regulation (EU) 2017/745 on medical devices, European Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulation n° 722/2012 on products utilizing tissues of animal origin, GMED certifies Mar 14, 2023 · Notified Bodies and Certificates. of active medical devices. Great Britain Medical Devices Regulations UK MDR (2002) Global Medical Device Single Audit Program (MDSAP) BSI The Netherlands (2797) is a leading full-scope Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. What is a Notified Body for Medical Device Development? A notified body is a private organization designated by an EU country to assess the conformity of certain products before being placed on the market. The European Association of Medical devices Notified Bodies (Team-NB) and its members fully support the objectives of the MD and IVD Regulations (MDR and IVDR) which aim to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting A designated body (Swiss term) is the same as a notified body (EU term). g. Being audited. Previous Aug 17, 2023 · By Oliver Eikenberg and Evangeline Loh. The JAT assess the competency and decide which devices the notified body can be designated to. Notified Bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation when a third party is Key Roles and Responsibilities of Notified Bodies in Medical Devices. In addition to providing recognised certification to the Austrian medical device Notified Body for Certification of Active Medical Devices . 5. We offer a full range of Management System and Certification Standards for the medical device industry including: ISO 13485 OGYEI is also the Designating Authority of the Hungarian notified bodies which can certify medical devices. 2021) internal Link: List of Notified Bodies – Directive 98/79/EC on in vitro diagnostic medical devices (status as of 25. List of 13 Notified Bodies registered with CDSCO under MDR 2017 as on 03-04-2023 1. com +91 9607006692 / 6823 / 6973 / 6945 / 4749 1 Table: Responsibilities and roles of Notified Bodies according to the EU Medical Device Regulation (2017/745) CHAPTER I – SCOPE AND DEFINITIONS Notified Body means a conformity assessment body designated in accordance with REGULATION (EU) 2017/745 as per Art. QMD Services is a notified body according to Regulation (EU) 2017/746 (IVDR) and now also according to Regulation (EU) 2017/745 (MDR). Depending on the risks associated with a medical device, an independent notified body has to be involved to check and/or test whether these legal requirements are fulfilled. com Tel : +44 (0)121 541 4743. Fig 4: Existing notified bodies: eventual scope of active implantable medical devices directive designation compared to that applied for 10 Fig 5: Proportion of joint assessment team reports containing nonconformities (15 As you are aware that Medical Device Rules 2017 has already been published vide G. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. time to time notifies Notified Bodies for the inspection for Medical Devices. For companies marketing their devices in the European Union, maintaining CE marking means MDR compliance regardless of challenges such as Notified Body staff shortages and work backlogs. Medical devices are regulated by the Regulation (EU) 2017/745 on Medical Devices (MDR). All MDR Notified bodies are not designated to be able to perform conformity assessments for medical devices. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR Feb 15, 2021 · The Notified body accredited under sub-rule (1) of Rule 13 shall be competent to carry out an audit of manufacturing sites of Class A and Class B medical devices to verify their conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority. A manufacturer is only allowed to market a medical device in Europe if it fulfils certain legal requirements. Details Our experts deliver a wide range of standard and non-standard tests on medical devices and certify them through our notified bodies. In addition to handling more volume, the requirements are also more stringent, which is leading to both closer scrutiny and longer review periods. Buying a used car. DEKRA is active almost everywhere in the world and the members of our medical device team have extensive expertise in a wide array of medical and in vitro devices. Nov 14, 2024 · Contact: Lynn Henderson. We are now accepting applications and are ready to start the review of medical devices for the MDR under our German-based notified body (0044). Notified bodies must base its evidence on conclusions presented by the manufacturer. If the requirements are being fulfilled, the This exchange occurs between EU Notified Body Partners and medical device QMS auditing organizations authorized by the Taiwan Food and Drug Administration (TFDA). 01. to show that the medical device has met the requirements and is therefore compliant with MDR. 1/Rec5 Title: Technical Documentation Page 2/21 vdtuev-document dn: \hoeppner\mp\nb\rec_vdt2\R2_5_1-5_rev4. As of May 26th, 2021 the MDR became in full force, and the MDD remains only valid during the transition period. Within the Kiwa Group, Kiwa Italy and Kiwa Turkey are Notified Bodies and can assess if medical devices with medium or high risk meet the legal requirements according to the MDD 93/42/EEC Directive. Oct 1, 2020 · UDEM Adriatic d. Dec 25, 2022 · A Notified Body (NB) is a conformity assessment body designated under the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746) that assesses the conformity of medical devices for CE marking before they enter the European Kiwa Cermet Italia (NB 0476) in Italy, Kiwa Belgelenddirme Hizmetleri (NB 1984) in Turkey, and Dare Services (NB 1912) in The Netherlands, are the Notified Bodies within the Kiwa Group, boasting a wide and in-depth experience in medical devices certification, with thousands of products already certified. Notified bodies are already swamped with MDR submissions, and as the IVDR deadline approaches and new manufacturers engage them, the bottlenecks will get even tighter for IVD NBs. Article 50 of the Regulation requires Notified Bodies to publish a list of fees associated with certifications and follow-ups, MDCG 2022-14 position paper emphasizes this obligation and invites NBs to adapt their costs to company sizes. Last update: December 2024 Notified Body and UK Approved Body lead times Quality Management System (QMS) audits and microbiology audits BSI The Netherlands (2797) is a leading Notified Body achieving full-scope designation under MDR and IVDR. While preparing for an audit is less than […] The Notified Body: The Conformity Assessment Body for Medical Devices in Europe 43 † Successful completion of a college or university degree † Four years of professional experience in the field of healthcare products and Artificial Intelligence (AI) in medical devices Page 3 of 28 This questionnaire is jointly published by the German Notified Bodies Alliance for Medical De-vices (Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland - IG-NB) and Team NB - The European Association of Medical devices Notified Bodies. This was in response to widespread concern that the performance of Notified Bodies in the medical device sector, and that of the Designating Authorities responsible for them, was variable and inconsistent. After MDR’s Date of Application, from 26 May 2021 the assessment must take place according to the rules of MDR. Jul 2, 2013 · A report from the European Medical Devices Expert Group, “Report on the Functioning of the Medical Devices Directive” (2002), 2 describes generally accepted concerns regarding the competence of Notified Bodies to perform the tasks for which they are designated, differences in interpretation between Notified Bodies and lack of transparency • Article 43(3) AIA says that Medical Devices Notified Bodies can control the AI conformity assessment as long as they comply with art. In July 2000, Member States and the European Commission agreed to set up the Notified Body Operations Group (NBOG). S. 42. Please, see below, how SGS can support your organization. TÜV NORD Cert has joined the list of notified bodies designated under the European Medical Device Regulation (MDR). Document: Link: Notified Bodies : Notified Bodies according to § 15 Medical Devices Act : In accordance with § 15 (4) of the German Medical Devices Act current information on the scope of designations as well as the identification numbers of German Notified Bodies in the ar Oct 4, 2022 · Notified bodies play the role of gatekeepers to the EU market for a majority of medical devices/in vitro diagnostics . For selected proposals from notified bodies, the expert panels will advise: either on a possible orphan status of a device; or on the data required for the clinical evaluation during an ongoing conformity assessment. Artificial Intelligence (AI) in medical devices Page 3 of 28 This questionnaire is jointly published by the German Notified Bodies Alliance for Medical De-vices (Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland - IG-NB) and Team NB - The European Association of Medical devices Notified Bodies. About Us: Est. • For Class III devices a Notified Body evaluates the design of the medical device, by reviewing the technical documentation submitted by the manufacturer, and issues a Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Recommendation NB-MED/2. TÜV SÜD Product Service is among the world's first certification bodies to receive designation as a Notified Body for the new Medical Device Regulation (MDR) by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG). Certification according to the Medical Device Regulation (MDR) (EU) 2017/745 and EN-ISO 13485. Notified Body assessment according to Regulation (EU) 2017/745 - the European Medical Device Regulation Certification according to ISO 13485 Certification according to MDSAP (Medical Device Single Audit Program) for Australia, Brasil, Canada, USA, Japan Sep 12, 2022 · Comparison of Notified Body (NB) fees for the Medical Devices Regulation. Medical device companies must choose from this list of accredited notified body firms as part of the conformity process. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Regulation (EU) 2017/745 on medical devices The Notified Body Opinion Maeve Lally, EMA Drug Device Guideline Drafting group, BWP Member Webinar on the implementation of Article 117 of the Medical Device Regulation 27 November 2020 An assessor’s view On the 19th of July, IMQ was appointed by the Ministry of Health as Notified Body (NB) for the new Regulation (EU) No. Aug 27, 2023 · A Notified Body (NB) is a conformity assessment body designated under the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746) that assesses the conformity of medical devices for CE marking before they enter the European TÜV SÜD becomes second Notified Body receiving Designation. Email us with corrections or additions. SGS Fimko Ltd is Notified Body 0598 that has been designated according to the MDR. Notified Body fees Notified bodies are authorised to assess compliance of medical devices with applicable requirements. We have achieved this distinction by being the most responsive Notified Body in the market by giving our clients the level of service they deserve. The European Association of Medical Devices Notified Bodies, Team-NB, released a white paper on August 10, 2023, called “New MDR Transition Timelines and Notified Body Capacity” (TEAM-NB Position Paper). Root canals. was founded in Zagreb in 2015 and functions as a System Certification Body and Notified Body for medical devices. Audits performed by notified bodies happen in two ways. After a medical device has been placed on the market, manufacturers must collect data in order to continuously confirm device quality, safety and performance. udemadriatic. regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices This letter confirms that mdc medical device certification GmbH (Kriegerstr. Company: Clinical Health Technologies Inc, USA. Which do you dread most? Yes, there are unicorns out there who actually enjoy audits, but most medical device regulatory professionals endure them as part of the job. Article 35: Authorities responsible for notified bodies. A list of active Notified Bodies recognised under the new MDR can be found on the European Commission New Approach Notified and It all started with the idea of unique and sustainable patient safety in the new EU medical device regulatory environment. Play We have full scope with more than 100 product categories, including: In May 2017, two new regulations relating to medical devices came into force, namely: 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. uyrdzsksyawoclfurdncdbgxjvewptcskvdfrwdentgpft