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!
 
T

tox472

#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!
 

pseudoazurin

Involved In Discussions
#5
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.

Hi Anyone still got a copy of the comparison of the GSPR vs ER that I can download, please?

Thx,
 
Thread starter Similar threads Forum Replies Date
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 4
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 6
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 44
C Deadline for compliance with added MDR harmonized standards CE Marking (Conformité Européene) / CB Scheme 2
D Is sampling allowed for MDR Class III products? EU Medical Device Regulations 0
A MDR Article 16 Certification of Distributors by a Notified Body? EU Medical Device Regulations 2
C MDR - Annex II _3. DESIGN AND MANUFACTURING INFORMATION_a EU Medical Device Regulations 3
F MDR GSPR 23.4 (c) EU Medical Device Regulations 0
B What are "appropriate drawings" required for a MDR in 21CFR820? ISO 13485:2016 - Medical Device Quality Management Systems 3
Ed Panek MDR Harmonized Standards Updated EU Medical Device Regulations 1
M MDR transfer for legacy devices EU Medical Device Regulations 1
Ed Panek Auditor Comment about MDR vs MDD EU Medical Device Regulations 10
N The new MDR requirements - SPR section #10.4 EU Medical Device Regulations 2
T Choosing a Notified Body for MDR - SGS/BSI/DNV/DQS-MED Registrars and Notified Bodies 0
M Reworking MDD product w MDR labeling CE Marking (Conformité Européene) / CB Scheme 5
A MDR and Poland EU Medical Device Regulations 6
Ed Panek Invitation to the MDR Dance EU Medical Device Regulations 5
M EU MDR language-Translation requiremens CE Marking (Conformité Européene) / CB Scheme 8
I What are suitable indicators and threshold values in MDR/IVDR? Medical Device and FDA Regulations and Standards News 5
A Sell-off legacy devices MDR EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
K Definition of SAE under MDR EU Medical Device Regulations 3
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
Ed Panek Clarity from EC on Importer/Distributor roles in MDR EU Medical Device Regulations 9
Pmarszal BS EN 20417:2021 - Implementation Timeline Aligned With MDR? Other ISO and International Standards and European Regulations 1
T Dental lab acrylics and MDR EU Medical Device Regulations 0
S Biggest issues when producing MDR compliant Technical Files / DD EU Medical Device Regulations 4
A Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device EU Medical Device Regulations 1
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 17
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
M EU MDR - Retrospective Study for expanding indications of a legacy device EU Medical Device Regulations 0
B MDR Technical Structure EU Medical Device Regulations 3
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
L Configurable UDI mdr EU Medical Device Regulations 0
O EU MDR labels EU Medical Device Regulations 1
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 2
E Article 17 MDR - (Re-)Processing EU Medical Device Regulations 0
H Article 22 MDR System EU Medical Device Regulations 16
L REACH compliance with MDR EU Medical Device Regulations 4
L EU MDR Ramifications for no expiration date on labeling EU Medical Device Regulations 1
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
F MDR – Article 120 – Transitional provisions EU Medical Device Regulations 8
H MDR Article 13(c) EU Medical Device Regulations 6
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0

Similar threads

Top Bottom