MDR Guidance Book - Useful for MDR transition?

Elsmar Forum Sponsor
#2
Yes I have a copy of the MedDev Solutions book and it is a very useful reference, I would say worth the money. It does cover all articles/annexes(including cross-references to all related articles/annexes) and has a lot more information besides (eg clinical evaluation requirements) You get a free copy (in addition to course notes) if you attend their two-day course which is also very useful.

Note however that it has nothing to do with RAPS. MedDev Solutions is a UK consultancy company, staffed by ex-BSI auditors.
 
Thread starter Similar threads Forum Replies Date
rob73 MDCG guidance on class 1 devices and MDR EU Medical Device Regulations 0
J CEN/TR 17223:2018 Guidance on the relationship between13485 and MDR.. worth the money?? ISO 13485:2016 - Medical Device Quality Management Systems 2
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
M Informational MHRA guidance updated to reflect the mDR – Clinical investigations of medical devices – Biological safety assessment Medical Device and FDA Regulations and Standards News 1
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 6
M Informational Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR Medical Device and FDA Regulations and Standards News 5
M EU MDR - UDI requirements and responsibility guidance EU Medical Device Regulations 1
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
M Medical Device News New guidance sheets for the MDR/IVDR published EU Medical Device Regulations 0
dgrainger EC-MDR Information for manufacturers guidance EU Medical Device Regulations 1
Sam Lazzara Summer 2013 - Best of FDA Guidance Documents - GLP Q&A, Clinical Monitoring, MDR Other US Medical Device Regulations 0
C New draft MDR reporting guidance Other US Medical Device Regulations 1
L Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
H MDD CM, MDR manufacturer. 2020. Is it ok? EU Medical Device Regulations 1
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 1
E UK MDR brexit out of sync with EU MDR deadline? Other Medical Device Regulations World-Wide 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
K Supply Agreement Regarding MDR 2017/745 - Manufacturer-supplier cooperation Other Medical Device Related Standards 0
Ed Panek Medical Device News MDR Delayed 1 year (Posted 4/2020) EU Medical Device Regulations 9
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
J PPE, the MDR and EU 2016/425 EU Medical Device Regulations 4
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 1
dgrainger Informational Postponement of MDR - adopted by the Commission - April 2020 Medical Device and FDA Regulations and Standards News 3
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
F The EU Drafts Bill to Postpone MDR by a Year (3/2020) Medical Device and FDA Regulations and Standards News 2
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 1
F Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact Medical Device and FDA Regulations and Standards News 11
Ajit Basrur Physical Address on Product Labels (EU MDR perspective) EU Medical Device Regulations 2
B Notified Bodies for Software (MDR) EU Medical Device Regulations 1
P MDR Rule 10 interpretation - Active Device EU Medical Device Regulations 3
JoCam Certified Body Audit of MDR requirements EU Medical Device Regulations 4
N Label Placement Requirement in MDD/MDR EU Medical Device Regulations 1
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
C MDR - Question around software accesories EU Medical Device Regulations 2
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
N Whether your NB is pushing you for MDR? Registrars and Notified Bodies 0
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
S Article 61 - MDR Clinical Investigation Requirement EU Medical Device Regulations 5
C Article 16 MDR - Medicine packaged together with Medical Device EU Medical Device Regulations 0
V Preparing the IFU in compliance with MDR 745, Chapter III Elsmar Xenforo Forum Software Instructions and Help 2
Similar threads


















































Top Bottom