EU MDR Safety & Performance Requirements vs. MDD ERs (June 2017)

Sam Lazzara

Trusted Information Resource
#1
I have begun my slow EU MDR digestion process by drafting a cross-reference between the MDR S&PRs versus the MDD ERs (Essential Requirements). You can access it here.

If you are interested in a MS Word version, click here.

I did my best to correlate the "old" Essential Requirements to the "new" Safety & Performance Requirements, but there is always a chance I screwed up. So please let me know if you see any problems, or see ways to improve it.
 
Elsmar Forum Sponsor

MDRexpert

Involved In Discussions
#2
Hi Sam,

The link doesn't work anymore for Europe MDR 2017/745 General Req vs. MDD 93/42/EEC Essential Req. Can you please upload the document here? Thanks!
 
#3
Hi Sam,
Thanks for sharing. BSI has issued an interesting white paper on this subject, if it can help in consolidating.
«General Safety and Performance
Requirements (Annex I) in the New
Medical Device Regulation
Comparison with the Essential Requirements of the Medical
Device Directive and Active Implantable Device Directive»
Gaëlle
 

MDRexpert

Involved In Discussions
#4
Hi Sam,

The link doesn't work anymore for Europe MDR 2017/745 General Req vs. MDD 93/42/EEC Essential Req. Can you please upload the document here? Thanks!
Just wanted to mention that for some reason the document does not open in IE. I tried again in google chrome and was able to see it.

Thanks Sam!
 
Thread starter Similar threads Forum Replies Date
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 2
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
P EU MDR and PSUR (Periodic Safety Update Report) EU Medical Device Regulations 31
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 3
K Biological indicator system classification under MDR EU Medical Device Regulations 2
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 1
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 0
J EU MDR getting closer - Special offer for Elsmar members 10/2020 EU Medical Device Regulations 9
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 2
G MDR translation requirements EU Medical Device Regulations 3
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
F MDR GSPR Checklist template EU Medical Device Regulations 4
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
S National registrations for MDR certified devices in absence of EUDAMED EU Medical Device Regulations 2
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
B MDR equvalent device - can you use a medicine as an equivalent 'device' EU Medical Device Regulations 8
N Harmonized Standards for MDR Certification EU Medical Device Regulations 7
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
H EU MDR Economic Operator notifications? EU Medical Device Regulations 1
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
R Declaration of conformity as per EU MDR (2017/745) CE Marking (Conformité Européene) / CB Scheme 5
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
B Herbal ingredients MDR EU Medical Device Regulations 0
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
A MDR GSPR Checklist wanted EU Medical Device Regulations 3
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
B EU MDR Perscription product guidance EU Medical Device Regulations 1
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
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 2
E UK MDR brexit out of sync with EU MDR deadline? UK Medical Device Regulations 4
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

Similar threads

Top Bottom