NaviReg is our new navigator in the complex landscape of EU and national regulations!
It offers a practical and intuitive solution for navigating and searching through regulations, guidelines, and related documents. The platform is being developed to make it easier for all of us to find our way through legislative requirements that often cross-reference one another. We’ve linked these references together and clearly structured the regulations into chapters, subchapters, articles…
We are continuously adding new regulations to NaviReg and enriching them with links. Our current focus is on covering legislation in the areas of medicinal products, medical devices, and cosmetics. All texts are sourced from official publications (currently EMA, EUR-Lex, SUKL) and are presented without any modifications.
In phase one, we are going to navigate you through the following regulations:
| Legislation / Guidelines, Q&A | Current situation (Text added –> Links added –> GL and Links integrated) |
|---|---|
| Good practice guide on recording, coding, reporting and assessment of medication errors | |
| Overview of comments received on draft ‘Good practice guide on recording, coding, reporting and assessment of medication errors’ (EMA/762563/2014) | |
| Overview of comments received on ‘Good practice guide on risk minimisation and prevention of medication errors’ (EMA/606103/2014) | |
| Risk minimisation strategy for high-strength and fixedcombination insulin products | |
| Overview of comments received on ‘Risk minimisation strategy for high strength and fixed combination insulin products, draft addendum to the good practice guide on risk minimisation and prevention of medication errors’ (EMA/686009/2014) | |
| Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures | |
| European Medicines Agency post-authorisation procedural advice for users of the centralised procedure | |
| European Medicines Agency post-authorisation procedural advice for users of the centralised procedure | |
| Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies | |
| PRAC rapporteur post-authorisation-safety-study-protocol assessment-report template | |
| Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies | |
| EudraLex – Volume 10 – Clinical trials guidelines | |
| Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use | Links added |
| Directive 2010/84/EU | |
| Regulation (EU) No 1234/2010 | Links added |
| Regulation (EC) No. 726/2004 | Links added |
| Commission Implementing Regulation No 520/2012 of 19 June 2012 | Links added |
| Regulation (EU) No 1027/2012 | |
| Directive 2012/26/EU | |
| EudraLex – Volume 9 – Pharmacovigilance guidelines | |
| Reporting requirements of individual case safety reports applicable to marketing-authorisation holders during the interim period | |
| Questions and answers on variations to an existing pharmacovigilance system as described in the detailed description of the pharmacovigilance system | |
| EU Individual Case Safety Report (ICSR)1 Implementation Guide | |
| Questions & answers on signal management | |
| Reflection paper on collecting and reporting information on off-label use in pharmacovigilance | |
| Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency | |
| Overview of comments received on ‘Detailed Guide regarding the Monitoring of Medical Literature and the Entry of Relevant Information into the EudraVigilance Database by the European Medicines Agency on Literature Monitoring’ (EMA/716877/2014) | |
| Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency | |
| List of substances and products subject to worksharing for signal management | |
| CHMP guideline on detection and management of duplicate individual cases and individual case safety reports | |
| Guideline on Detection and Management of Duplicate Individual Cases and Individual Case Safety Reports (ICSRs) | |
| EudraLex – Volume 9A – Questions and answers on implementation | |
| Implementation plan for the ‘Note for guidance – EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)’ (EMA/H/20665/04/Final Rev. 2) | |
| Pharmacovigilance fees payable to the European Medicines Agency (EMA) | |
| Report on pharmacovigilance tasks | |
| European Medicines Agency post-authorisation procedural advice for users of the centralised procedure | |
| Guidelines on good pharmacovigilance practices (GVP) – Annex I | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module I | Links added |
| Guidelines on good pharmacovigilance practices (GVP) – module II | Links added |
| Guidelines on good pharmacovigilance practices (GVP) – module III | Links added |
| Guidelines on good pharmacovigilance practices (GVP) – module IV | Links added |
| Guidelines on good pharmacovigilance practices (GVP) – module V | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module VI | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module VI (Addendum I) | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module VII | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module VIII | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module IX | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module X | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module XV | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module XVI | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module XVI (Addendum I) | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module XVI (Addendum II) | Text added |
| Guidelines on good pharmacovigilance practices (GVP) – module XVI (Addendum III) | Text added |
| Regulation 507/2006 | |
| Regulation 1901/2006 | |
| Regulation 1394/2007 | |
| Regulation 141/2000 | |
| Regulation 712/2012 | |
| Regulation 658/2007 | |
| Regulation 1277/2005 | |
| Regulation 111/2005 | |
| Regulation 297/2009 | |
| Regulation 273/2004 | |
| Regulation 850/2004 | |
| Regulation 1084/2003 | |
| Regulation 1085/2003 | |
| Regulation 953/2003 | |
| Regulation 847/2000 | |
| Regulation 2141/96 | |
| Regulation 1662/95 | |
| Regulation 540/95 | |
| Regulation 297/95 | |
| Regulation 2024/568 | |
| Regulation 765/2008 | |
| Regulation 1768/92 | |
| Regulation 469/2009 | |
| Regulation 536/2014 | |
| Regulation 1902/2006 | |
| Regulation 668/2009 | |
| Regulation 207/2012 | |
| Regulation 722/2012 | |
| Regulation 920/2013 | |
| Regulation 255/2011 | |
| Regulation 2021/2226 | |
| Directive 2001/83/ES | |
| Directive 2011/62/EU | |
| Directive/2005/62/ES | |
| Directive 2006/17/ES | |
| Directive 2005/61/ES | |
| Directive 2005/28/ES | |
| Directive 2004/33/ES | |
| Directive 2004/23/ES | |
| Directive 2004/10/ES | |
| Directive 2003/94/ES | |
| Directive 2002/98/ES | |
| Directive 2001/20/ES | |
| Directive 2001/18/ES | |
| Directive 90/219/EHS | |
| Directive 78/25/EHS | |
| Directive 2007/47/ES | |
| Directive 98/8/ES | |
| Directive 89/105/EHS | |
| Directive 2004/27/ES | |
| Directive 2007/51/ES | |
| 94/358/ES | |
| 75/320/ES | |
| 2001/571/ES | |
| 2002/364/ES | |
| 2009/886/ES | |
| 2011/869/ES | |
| 2008/932/ES | |
| 2008/768/ES | |
| 2010/227/EU | |
| 2013/172/EU | |
| 2013/473/EU | |
| Regulation 2017/745 | |
| Regulation 2017/746 | |
| Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies | |
| Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies | |
| Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR | |
| Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3 | |
| Background note on the use of the Manual on borderline and classification for medical devices under the Directives. | |
| Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices | |
| Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices | |
| Guidance on classification of medical devices | |
| Helsinki Procedure for borderline and classification under MDR & IVDR | |
| Guidance notes for manufacturers of class I medical devices | |
| Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 | |
| Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED | |
| Clinical evaluation of orphan medical devices | |
| “Guidance on the Investigator’s Brochure content Guidance on the Investigator’s Brochure content Appendix A of the MDCG 2024-5″ | |
| “Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices Clinical Investigation Plan Synopsis Template” | |
| Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence | |
| Commission Guidance on the content and structure of the summary of the clinical investigation report | |
| Substantial modification of clinical investigation under Medical Device Regulation | |
| Instructions for generating CIV-ID for MDR Clinical Investigations | |
| Clinical investigation application/notification documents | |
| Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation | |
| Clinical evaluation assessment report template | |
| “Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form” | |
| Guidance on PMCF evaluation report template | |
| Guidance on PMCF plan template | |
| “Guidance on sufficient clinical evidence for legacy devices Background note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation” | |
| Guidance on clinical evaluation – Equivalence | |
| Summary of safety and clinical performance | |
| Questions and Answers on Custom-Made Devices | |
| Device Specific Vigilance Guidance (DSVG) Template | |
| DSVG 01 on Cardiac ablation | |
| DSVG 02 on Coronary stents | |
| DSVG 03 on Cardiac implantable electronic devices (CIEDs) | |
| DSVG 04 on Breast implants | |
| DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence | |
| Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 | |
| Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 | |
| “Guidance on standardisation for medical devices” | |
| Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) | |
| Guidance on cybersecurity for medical devices | |
| Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | |
| Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components | |
| Guidance on the safe making available of medical device software (MDSW) apps on online platforms | |
| FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) | |
| Guidance on qualification of in vitro diagnostic medical devices | |
| “Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 Appendix – Performance Study Summary Safety Reporting Form” | |
| Summary of safety and performance template | |
| Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | |
| Substantial modification of performance study under Regulation (EU) 2017/746 | |
| Performance study application/notification documents under Regulation (EU) 2017/746 | |
| Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD | |
| Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 | |
| Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | |
| Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC | |
| Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR | |
| Verification of manufactured class D IVDs by notified bodies | |
| Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) | |
| Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 |