Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR)

GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
L MedTech Europe IVDR Update EU Medical Device Regulations 0
M Informational Medtech Europe presentation – – Industry Perspective on the Implementation Status of the MDR/IVDR Medical Device and FDA Regulations and Standards News 0
M Informational Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR Medical Device and FDA Regulations and Standards News 5
M Medical Device News MedTech Europe Statement on the Implant Files 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
U Examples of Quality Objectives for a Medtech start up ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; 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
L Medtech regulation under scrutiny Other Medical Device Regulations World-Wide 1
Q Best country to import medical devices into Europe Other Medical Device and Orthopedic Related Topics 0
M Combination Products MAA in Europe Medical Device and FDA Regulations and Standards News 3
R Compatibility studies for Combination Products - Europe Medical Device and FDA Regulations and Standards News 2
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
N Importer of record - Europe EU Medical Device Regulations 0
A Donating sterilizing gel - Is it legal in Europe? EU Medical Device Regulations 1
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
E Machines in Europe not in compliance with the EC directive CE Marking (Conformité Européene) / CB Scheme 0
M One clinical design: Russia and Europe Other Medical Device and Orthopedic Related Topics 0
S Differences in CB expectations between the US and Europe Registrars and Notified Bodies 3
K Is Compliance Testing of IEC 60601-2-63 mandatory for Europe - Dental X-Ray machine CE Marking (Conformité Européene) / CB Scheme 3
M Informational EC – Guide for referencing standards in public procurement in Europe (JIS Action 11) Medical Device and FDA Regulations and Standards News 0
M RFID (Radio Frequency Identification) Registration in Europe and in MENA countries EU Medical Device Regulations 1
I Where to submit Adverse Events Reports in Europe EU Medical Device Regulations 7
K CE Mark in Material Testing Machines sold to Europe from the US CE Marking (Conformité Européene) / CB Scheme 3
C Exporting Adult Products from Europe to the United States 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Training courses for improving 'Coaching and Mentoring skills' within Europe Training - Internal, External, Online and Distance Learning 1
A US patient gets Medical Device in Europe and needs spare parts 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Need of EU representative if CE marked Med Device not marketed in Europe EU Medical Device Regulations 8
R Is there a mandatory medical device warehouse standard for europe? EU Medical Device Regulations 3
M CE Mark outside of Europe - Implications EU Medical Device Regulations 4
S Is Combination Product regulation available for Europe? EU Medical Device Regulations 2
M API Q1 Validation in Europe Oil and Gas Industry Standards and Regulations 8
T Testing Laboratories in Europe to IEC/EN 60601-2-47 IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
C Selling of Research products in Europe EU Medical Device Regulations 9
D Use By and Expiration Date for a Class 3 Medical Device in Europe CE Marking (Conformité Européene) / CB Scheme 3
J Lean Transformation Project - Distribution centre in Europe Lean in Manufacturing and Service Industries 1
I Quality and Operational Excellence Training Institutes in Europe Training - Internal, External, Online and Distance Learning 1
M MDD Europe: Use EN ISO 14971:2012 or ISO 14971:2007 Quality Manager and Management Related Issues 9
S What are export requirements for Class I/II Medical Devices in Europe? ISO 13485:2016 - Medical Device Quality Management Systems 2
N Which regulations apply to Medical Stand Alone Software in Europe? ISO 13485:2016 - Medical Device Quality Management Systems 3
K Medical Device Identification Europe FDA CMDR Other ISO and International Standards and European Regulations 7
S QMS to demonstrate Compliance to Canada, Europe and Japan Other Medical Device Regulations World-Wide 7
A CE Certificate is valid until 3.12.2013 - Can I still sell the products in Europe? EU Medical Device Regulations 10
T CE Marking - Exporting replicas (Airsoft) to Europe CE Marking (Conformité Européene) / CB Scheme 1
G Can a Distributer in USA sell a medical device (CE marked) to Europe? CE Marking (Conformité Européene) / CB Scheme 2
J Shipping Liquids (Small Bottles of Ultrasound Gel) to Europe EU Medical Device Regulations 4
S GMP Comparative Information for Canada, US and Europe Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
M Proposal for revision of the Medical Devices Directives in Europe EU Medical Device Regulations 10
Sam Lazzara Updated Europe Harmonised Standards Lists (2012-08-30) EU Medical Device Regulations 3

Similar threads

Top Bottom