Swiss Database on Medical Devices - swissdamed!https://youregulate.com/document/swiss-database-on-medical-devices---swissdamedNotified Body Confirmation Letter is published! Free of charge.https://youregulate.com/document/notified-body-confirmation-letter-is-published-free-of-chargeMHRA guidance on Regulating medical devices in the UK has been updated!https://youregulate.com/document/mhra-guidance-on-regulating-medical-devices-in-the-uk-has-been-updatedNew timelines for CE marked medical devices to continue to be placed on the Great Britain market!https://youregulate.com/document/new-timelines-for-ce-marked-medical-devices-to-continue-to-be-placed-on-the-great-britain-marketMHRA extended the transition period for MORE!https://youregulate.com/document/mhra-extended-the-transition-period-for-moreThe UK and Switzerland have embraced the EU MDR extension!https://youregulate.com/document/the-uk-and-switzerland-have-embraced-the-eu-mdr-extensionLanguage Requirements under MDR (EU) 2017/745https://youregulate.com/document/language-requirements-under-mdr-eu-2017745Swissmedic inspects Class I manufacturers in Switzerland!https://youregulate.com/document/swissmedic-inspects-class-i-manufacturers-in-switzerlandhttps://youregulate.com/document/official-qa-on-the-extension-of-the-mdr-publishedHave your say! EU proposes Master UDI for contact lenseshttps://youregulate.com/document/have-your-say-eu-proposes-master-udi-for-contact-lensesIt's time for EUDAMED!https://youregulate.com/document/its-time-for-eudamedProposal for amending the medical devices transition - feedback open!https://youregulate.com/document/proposal-for-amending-the-medical-devices-transition---feedback-openProposal for amending the medical devices transition extension was published! https://youregulate.com/document/proposal-for-amending-the-medical-devices-transition-extension-was-published-MDR Templateshttps://youregulate.com/document/mdr-templatesProducts without an intended medical purpose!https://youregulate.com/document/products-without-an-intended-medical-purposeEU MDR BRIDGEhttps://youregulate.com/document/eu-mdr-bridgeMORE Portal - UKhttps://youregulate.com/document/more-portalEU MDR deadline/transition!https://youregulate.com/document/eu-mdr-deadlinetransitionMHRA update!https://youregulate.com/document/mhra-updateConsultation on the future regulation of medical devices in the United Kingdomhttps://youregulate.com/document/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdomEntry into force of the IvDO!https://youregulate.com/document/ivdo-adoptedUKCA markinghttps://youregulate.com/document/ukca-markingIVDR applicable for new products https://youregulate.com/document/ivdr-applicable-for-new-products--new-and-prolonged-extensions-for-legacy-productsIVDR amended!https://youregulate.com/document/ivdr-amendedChecklist for GSPR compliance (IVDD-IVDR)https://youregulate.com/document/checklist-for-gspr-compliance-ivdd-ivdrChecklist for GSPR compliance (MDD-MDR)https://youregulate.com/document/checklist-for-gspr-compliancehttps://youregulate.com/document/art-14Swiss Authorized Representative (CH-REP)https://youregulate.com/document/swiss-authorized-representative-ch-repEuropean Commission published further guidance documentshttps://youregulate.com/document/european-commission-published-further-guidance-documentsBIG news for IVD manufactures!https://youregulate.com/document/big-news-for-ivd-manufactureshttps://youregulate.com/document/qa-mdrivdr-verificationRegulation 2020/2151 on single-use plastic productshttps://youregulate.com/document/regulation-20202151-on-single-use-plastic-productsGuidance - in vitro diagnostic medical devices according to Regulation (EU) 2017/746https://youregulate.com/document/guidance---in-vitro-diagnostic-medical-devices-according-to-regulation-eu-2017746Update EUDAMEDhttps://youregulate.com/document/update-eudamedUKRP Templatehttps://youregulate.com/document/uk-rp-templateThe MDR 2024 deadline!https://youregulate.com/document/the-mdr-2024-deadlineBrexit finalized!https://youregulate.com/document/new-uk-regulationActor registration modulehttps://youregulate.com/document/actor-registration-moduleFDA issues guidance on Medical Devices Containing Nitinolhttps://youregulate.com/document/fda-issues-guidance-on-medical-devices-containing-nitinolMDR (EU) 2017/745 EN-DE Book (pdf)
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https://youregulate.com/document/mdr-en-de-bookList of Notified Bodies under MDR/IVDRhttps://youregulate.com/document/list-of-notified-bodies-under-mdrivdrUnique Device Identification (UDI) System - FAQshttps://youregulate.com/document/unique-device-identification-udi-system---faqsUpdate: 2020.07.09Ludger pointed out below the new revision 7.2.1 of the form. Here it is to download.https://youregulate.com/document/manufacturer-incident-report-2020DIMDI and BfArM merged. Now it is BfArM! Eudamed News!https://youregulate.com/document/dimdi-and-bfarm-merged-now-it-is-bfarm-eudamed-newsReview and Update of Device Establishment Inspection Processes and Standardshttps://youregulate.com/document/review-and-update-of-device-establishment-inspection-processes-and-standardsMDR and IVDR Implementing measures rolling planhttps://youregulate.com/document/mdr-and-ivdr-implementing-measures-rolling-planGuidance on the renewal of designation and monitoring of notified bodieshttps://youregulate.com/document/guidance-on-the-renewal-of-designation-and-monitoring-of-notified-bodiesGood Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturinghttps://youregulate.com/document/good-manufacturing-practice-considerations-for-responding-to-covid-19-infection-in-employees-in-drug-and-biological-products-manufacturingRegulation (EU) 2017/745 - Consolidated text!The consolidated text also includes the MDR delay. From now on we would not expect any major changes anymore. https://youregulate.com/document/regulation-eu-2017745---consolidated-textExciting developments regarding Harmonized Standards!M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Councilhttps://youregulate.com/document/exciting-developments-regarding-harmonized-standardsRevised list of IMDRF codes also includes Annex G (component codes)https://youregulate.com/document/revised-list-of-imdrf-codes-including-annex-g-component-codesFDA issues two guidances to accelerate COVID-19 treatmentshttps://youregulate.com/document/fda-issues-two-guidances-to-accelerate-covid-19-treatmentsNew MDCG guidance documents!The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.https://youregulate.com/document/new-mdcg-guidance-documentsCOVID-19 info!European Commission Comments for Consideration on COVID-19 In Vitro Diagnostic Tests and Their Performance Commission Working Document - Current Performance of COVID-19 Test Methods and Devices and Proposed Performance CriteriaAn overview of the rapid test situation for COVID-19 diagnosis on the EU/EEAGuidance on devices in the COVID-19 contexthttps://youregulate.com/document/covid-19Proposal for 1-year MDR delay!On Friday, April 17, 2020, the European Parliament approved to delay by one year the EU Medical Device Regulation with 693 votes in favor, 1 against and 2 abstentions. Great support!The delay is due to the COVID-19 fight but it will be beneficial for others as well.Now it is in writing and set in stone with the publication on the Official Journal of the European Union.https://youregulate.com/document/proposal-for-1-year-mdr-delayStandards free of charge!CEN and CENELEC make European standards freely available relevant for the crisis. Standards are created by standard organizations who carefully draft those. It sometimes takes several years of negotiations until a standard sees the light and can be used.https://youregulate.com/document/standards-free-of-chargeNo CE marking needed!On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 crisis. Those are Products covered by Regulation (EU) 2016/425 on personal protective equipment (PPE) and medical devices covered by the Directive 93/42/EEC (MDD) or Regulation (EU) 2017/745 (MDR).https://youregulate.com/document/no-ce-marking-neededNew and current standards have been harmonized with the current directives!On 25 March 2020, the Commission adopted three Implementing Decisions on harmonised standards which will allow manufacturers to place on the market devices that play a pivotal role in the current coronavirus pandemic:https://youregulate.com/document/new-and-current-standards-have-been-harmonized-with-the-current-directivesOpinion MDR Article 120 (3)https://youregulate.com/document/opinion-mdr-article-120-3-1581342797Second Corrigendum to the MDR and IVDRCorrigendum to 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 93/42/EECCorrigendum to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EUhttps://youregulate.com/document/second-corrigendum-to-the-mdr-and-ivdrThe European Medical Device Nomenclature (EMDN)The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.https://youregulate.com/document/the-european-medical-device-nomenclature-emdnThe CND NomenclatureThe purpose of this document is to provide information regarding the basic principles and the structure of the Italian “Classificazione Nazionale Dispositivi medici” (CND). In March 2019, and according to the criteria set out by the Medical Device Coordination Group1 (MDCG), the CND was selected as the basis for the future European Medical Device Nomenclature (EMDN). The EMDN will support the functioning of EUDAMED as stated by the MDCG and in accordance with Articles 23 of Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746.https://youregulate.com/document/the-cnd-nomenclatureUse of Symbols to Indicate Compliance with the MDRThe Medical Devices Regulation 2017/745/EU (‘MDR’) has new requirements that ask for various kinds of information to be indicated on the label of medical devices. To comply with this requirement within the short term and in a harmonised manner, before the international standard is available, MedTech Europe publishes the present guidance on symbols for the following informationhttps://youregulate.com/document/use-of-symbols-to-indicate-compliance-with-the-mdrGuidance on Cybersecurity for medical deviceshttps://youregulate.com/document/guidance-on-cybersecurityGuidance notes for manufacturers of class I medical deviceshttps://youregulate.com/document/mdcg-2019-15-guidance-notes-for-manufacturers-of-class-i-medical-devicesGuidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentationhttps://youregulate.com/document/mdcg-2019-13-guidance-on-samplingExplanatory note on MDR codeshttps://youregulate.com/document/explanatory-note-on-mdr-codesICCBBA Basic UDI-DIhttps://youregulate.com/document/iccbba-basic-udi-diHIBCC Basic UDI-DIhttps://youregulate.com/document/hibcc-basic-udiGS1 Basic UDI-DIhttps://youregulate.com/document/gs1-basic-udi-dihttps://youregulate.com/document/ifa-udi-hri--aidc-formatsEUDAMED UDI Device Data Dictionaryhttps://youregulate.com/document/eudamed-udi-device-data-dictionaryIFA Basic UDI-DIhttps://youregulate.com/document/ifa-basic-udi-dihttps://youregulate.com/document/gs1-udi-hri--aidchttps://youregulate.com/document/hibcc-udi-hri--aidc-formatshttps://youregulate.com/document/iccbba-udi-hri--aidc-formatsOngoing Guidance development within MDCG Subgroupshttps://youregulate.com/document/ongoing-guidance-development-within-mdcg-subgroupsQuestions and answers: Requirements relating to notified bodieshttps://youregulate.com/document/mdcg-2019-6-v2-questions-and-answers-requirements-relating-to-notified-bodiesDesignating authority's final assessment form: Key Informationhttps://youregulate.com/document/designating-authoritys-final-assessment-form-key-informationGuidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDRhttps://youregulate.com/document/guidance-on-qualification-and-classification-of-software-in-regulation-eu-2017745--mdr-and-regulation-eu-2017746--ivdrApplication of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEChttps://youregulate.com/document/application-of-transitional-provisions-concerning-validity-of-certificates-issued-in-accordance-to-directives-90385eec-and-9342eecSummary of safety and clinical performance. A guide for manufacturers and notified bodies.https://youregulate.com/document/mdcg-20199---summary-of-safety-and-clinical-performanceSingle-use medical devices - safety and performance requirements for reprocessinghttps://youregulate.com/document/single-use-medical-devices---safety-and-performance-requirements-for-reprocessingGuidance on Implant Cardhttps://youregulate.com/document/guidance-on-implant-cardEC Issues Additional Guidance on Device Vigilance Systemhttps://youregulate.com/document/ec-issues-additional-guidance-on-device-vigilance-systemGuidance on Article 15 MDR-IVDR - Person responsible for Regulatory Compliancehttps://youregulate.com/document/guidance-on-article-15-mdr-ivdr---person-responsible-for-regulatory-compliance