MDR "Common Specifications" (CS) - If not standards, then what?

M

Mark Meer

Trusted Information Resource
I'm hoping someone can elaborate (perhaps with examples) of what is meant by "Common Specifications (CS)" in the MDR.

The definition given is:
(71) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
Click to expand...

...and there are some more details in Article 9.

But I'm still not clear what these are... In principle, the concept seems pretty similar to harmonised standards.

Is there an authoritative site where these CSs reside or can be searched? How do I know if there are any that apply to my device?
 
C

craiglab

Involved In Discussions
The first CS being worked on is for reprocessing of SUDs. You can download the draft and read comments here:
Single-use medical devices - safety and performance requirements for reprocessing
It is scheduled for release in Q1. The next CS, which is scheduled for release in Q2, is for Products without a medical purpose.
The relationship to harmonized standards is found in Article 9: CS will be adopted where no harmonized standards exist, or where the harmonized standard is insufficient, or where there is a need to address public health concerns. And manufacturers SHALL comply with CS unless they can duly justify an equal or better solution.
 
M

Mark Meer

Trusted Information Resource
Thanks craiglab, that clears things up a lot. Basically, from what you say, it's something written into the regulations that, at the moment, is not applicable to most manufacturers.

Moving forward however, is there a notification service I can subscribe to specific to CS development/release in order to stay informed as to what might apply to my devices in the future?

craiglab said:
...And manufacturers SHALL comply with CS unless they can duly justify an equal or better solution.
Click to expand...
Despite the lack of explicit "shall", this is more-or-less how harmonised standards are treated in the industry (in my experience), which is why I say that conceptually, these Common Specifications seem very similar to harmonised standards.
 
D

DutchMarten

Starting to get Involved
Just read up on this subject and wanted to add that the Common Specifications can be found on the official website for EU laws, see: eur-lex.europa.eu . There you can find them by searching for "Commission Implementing Regulation" in combination with the regulation which it falls under (so for instance "Regulation (EU) 2017/745" for the MDR).

The way I understand it Common Specifications differ from Guidance in that they become binding law upon their publication. They are however usually the result of consultation of the EU with the MDCG.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J Common Specifications per MDR EU Medical Device Regulations 2
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
Ed Panek MDR and Accessories EU Medical Device Regulations 0
N MDR EU Medical Device Regulations 1
R MDR vs. Machinery Directive - Single EU Declaration of Conformity EU Medical Device Regulations 2
M EU MDR Economic operator -Importer EU Medical Device Regulations 2
J MDR Consequences on existing stock for PLM EU Medical Device Regulations 3
A Class Ir device have to be certified under MDR ? EU Medical Device Regulations 2
B Under MDR, are VATS and MICS still considered just class Ir? ISO 13485:2016 - Medical Device Quality Management Systems 1
G Trend analysis according to Article 88, MDR (EU), type of data point. EU Medical Device Regulations 1
S MDD Certificate extension according to 2023/67 MDR extension EU Medical Device Regulations 3
A Will EU MDR Notifying Body CER and CEP Technical documents Other Medical Device Related Standards 1
D What does a contract manufacturer have to do to comply with for MDR? EU Medical Device Regulations 2
G Trend Reporting according to Article 88 MDR, custom made implant EU Medical Device Regulations 5
G MDR critical supplier audit checklist EU Medical Device Regulations 0
G MDR/UKCA Supplier Audits EU Medical Device Regulations 3
C Revising a DoC for a legacy device under MDR/IVDR transitional periods EU Medical Device Regulations 7
D MDR literature review on device without clinical claims EU Medical Device Regulations 7
B EU MDR transitional period extension EU Medical Device Regulations 4
I Classification of device per Annex 8 of the EU MDR EU Medical Device Regulations 4
R Class I devices in the extended MDR transition period EU Medical Device Regulations 17
A MDR- Technical Documents EU Medical Device Regulations 4
P Distribution of "CE" Declaration of conformity under MDR EU Medical Device Regulations 3
E Expired CE with no pending MDR certification EU Medical Device Regulations 4
T SaMD labeling requirements - MDR IEC 62304 - Medical Device Software Life Cycle Processes 3
L Annex of ISO 13485:2016 as harmonized standard (MDR/IVDR) ISO 13485:2016 - Medical Device Quality Management Systems 2
P MDR Reporting Requirements for Devices Already covered in a correction under 21 CFR 806 US Food and Drug Administration (FDA) 0
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
G MDR CE Expiration Date EU Medical Device Regulations 4
C MDR vs CMDR EU Medical Device Regulations 4
O MDR language requirements EU Medical Device Regulations 12
K Whether the product is an accessory according to the MDR definition EU Medical Device Regulations 3
L Adverse Event Reporting Flowchart (MDR EU) EU Medical Device Regulations 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
Ed Panek MDR Delay? EU Medical Device Regulations 2
dgrainger Informational Proposal to address MDR challenges EU Medical Device Regulations 23
goldenguo MDR/IVDR Insurance and Liability for Manufacturers, EU Representative and Importer EU Medical Device Regulations 3
B MDR PSUR versus Canadian Summary report EU Medical Device Regulations 4
C MDR 2017/744 Article 22 EU Medical Device Regulations 3
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
D EU MDR Derogation EU Medical Device Regulations 0
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
M On-demand EU MDR Compliance toolkit with online training courses, templates & document management system Training - Internal, External, Online and Distance Learning 0
M EU MDR (GSPR Checklist) consolidated with TGA EP Checklist EU Medical Device Regulations 5
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 8
H MDR clinical evaluation EU Medical Device Regulations 0
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1

Similar threads

Top Bottom