Informational Commission Regulation (EU) 2019/319 of 6 February 2019 amending previous regulations as regards health certification at import into the Union concerni

Thread starter Similar threads Forum Replies Date
E Commission Regulation (EU) No. 207/2012 E-IFU Applicability EU Medical Device Regulations 5
M Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR) Medical Device and FDA Regulations and Standards News 0
M Informational From the Implant Files – French commission calls for massive medtech regulation overhaul Medical Device and FDA Regulations and Standards News 1
dgrainger Informational Postponement of MDR - adopted by the Commission - April 2020 Medical Device and FDA Regulations and Standards News 3
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
M Informational EU – Commission Implementing Decision (EU) as regards the designation of expert panels in the field of medical devices Medical Device and FDA Regulations and Standards News 0
M Informational European Commission expert panels on medical devices and in vitro diagnostic devices Medical Device and FDA Regulations and Standards News 0
M Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Medical Device and FDA Regulations and Standards News 0
M Medical Device News EC – Commission reply to a Petition “For a Compensation Fund for PIP Breast Implants and CE” from the website change.org Medical Device and FDA Regulations and Standards News 0
M Medical Device News MedTech Europe - European Parliament further clarifies Commission proposal on HTA for medical technologies EU Medical Device Regulations 0
R Brexit - European Commission - The impact of the Brexit per March 29, 2019 EU Medical Device Regulations 3
E ISO 15223-1 (Medical Device Label Symbols) - Revisions, EU commission? Other ISO and International Standards and European Regulations 1
CharlieUK New EU Commission "Blue Guide" to CE Marking - 2014 CE Marking (Conformité Européene) / CB Scheme 2
somashekar Definition Supply and Erection / Supply and Commission - Technical Quotation Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
P EU Commission requires NB (Notified Body) Unannounced Visits EU Medical Device Regulations 48
M ISO TS 24971 Updates and formal objection of the European Commission to ISO 14971 ISO 14971 - Medical Device Risk Management 24
Ronen E European Commission calls for action following PIP's Breast Implant Saga EU Medical Device Regulations 1
M European Commission Questions Risk Management Standard ISO 14971 - Medical Device Risk Management 7
Ajit Basrur U.S. ? China Joint Commission on Commerce and Trade (JCCT) - Fact Sheet ISO 13485:2016 - Medical Device Quality Management Systems 2
P How does Commission Directive 2008/58/EC affect small suppliers Miscellaneous Environmental Standards and EMS Related Discussions 4
T EC Legislation - Power Difference on Directive, Commission Decision, Council Decision Various Other Specifications, Standards, and related Requirements 2
A En 550/554 - The European Commission Standards Harmonization ISO 13485:2016 - Medical Device Quality Management Systems 2
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
F Component maintenance qualification - Regulation (EU) No 1321/2014 Article 5 EASA and JAA Aviation Standards and Requirements 6
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Z Class I marketing regulation and supply chain Other Medical Device Regulations World-Wide 0
H Software Interface Translation IVD Regulation EU Medical Device Regulations 0
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
M Canadian regulation gap assessment Canada Medical Device Regulations 7
dgrainger Informational UK guidance on Device regulation from Jan 2021 published UK Medical Device Regulations 19
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
F General Data Protection Regulation (GDRP) CE Marking (Conformité Européene) / CB Scheme 6
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 8
H Incomplete IVD kit under IVD Regulation EU Medical Device Regulations 1
S OTC and Prescription use in EU regulation EU Medical Device Regulations 3
H Online courses/program for medical device regulation EU Medical Device Regulations 4
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
L Label Content Requirements under MDR regulation EU Medical Device Regulations 5
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
shimonv Recall - Is there a European regulation for recalls of products EU Medical Device Regulations 4
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
M Informational ANVISA regulation for personalized/custom medical devices – RESOLUÇÃO – RDC Nº 305, DE 24 DE SETEMBRO DE 2019 Medical Device and FDA Regulations and Standards News 0
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems US Food and Drug Administration (FDA) 18
M Informational BSI certifies first product to the Medical Devices Regulation Medical Device and FDA Regulations and Standards News 10
M Informational New designated Notified Body for Regulation (EU) 2017/745 (MDR) included in Nando – IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Medical Device and FDA Regulations and Standards News 3
M Informational UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario – Human Medicines and Medical Devices (Amendm Medical Device and FDA Regulations and Standards News 3

Similar threads

Top Bottom