SBS - The Best Value in QMS software

EU MDR GSPR 23.1 information on website

Ellison

Starting to get Involved
#1
Good Morning,
I was wondering how everyone else is interpreting the beginning paragraph of GSPR 23.1 (See below). We had in external trainer tell us this had to be the IFU, but after some reading and discussion and are some different opinions. Could it a brochure on the website, could it be aPDF of the IFU, . A little back ground, we currently do not have eIFU’s and do not plan on going that route since we dont really meet the EU regulation requirements to have or need an eIFU. In reality the IFU would be the easiest to maintain for this but there are also addition resources to take into consideration.

Just curious what that knowleadgable minds here are thinking around this additional requirement that is kind of snuck into the GSPR..

23.1. General requirements regarding the information supplied by the manufacturer
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:


Kind Regards,
Ellison
 
Elsmar Forum Sponsor

MDRexpert

Involved In Discussions
#2
23.1 General requirements regarding the information supplied by the manufacturer each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:
(a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
(b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.
(c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.
(d) Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section.
(e) Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
(f) Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation
(g) Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer
(h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognized symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.
 

François

Involved In Discussions
#3
In my understanding, you can use what ever format you want to display the requested informations as long as they are aligned with what is written on the label or IFU about the requested topics (identification, performance and safety). Indeed, I think that it will be easier to provide an electronic copy of the IFU to avoid duplication of sources.
 
Thread starter Similar threads Forum Replies Date
S MDR GSPR Standards EU Medical Device Regulations 0
J EU MDR GSPR 10.4.3 and 10.4.4 EU Medical Device Regulations 2
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
F MDR GSPR Checklist template EU Medical Device Regulations 7
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
A MDR GSPR Checklist wanted EU Medical Device Regulations 6
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 4
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 2
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
N EU MDR and its impact on existing Registrations EU Medical Device Regulations 1
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 3
Y MDR Transition - make "Available on the market" after CE certificate expiration EU Medical Device Regulations 2
C MDR Classification Rule 10 EU Medical Device Regulations 13
C MDR software classification EU Medical Device Regulations 12
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 8
R Products not within the MDR grace period EU Medical Device Regulations 1
shimonv MDR transition checklist EU Medical Device Regulations 0
K Re-packaging under MDR EU Medical Device Regulations 3
Ed Panek Upcoming NB MDD ---> MDR Crunch EU Medical Device Regulations 0
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
N Looking for a recommendation for an EU MDR Importer EU Medical Device Regulations 1
JoCam Rental and MDD versus MDR EU Medical Device Regulations 1
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 5
Raisin picker CECP, consultation according to Art 54 MDR EU Medical Device Regulations 1
K Question on MDR classification EU Medical Device Regulations 4
M STED vs MDR EU Medical Device Regulations 0
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
K Importer in EU, but not distribute in the EU - MDR obligations EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Responsibilities of Importers / Distributors - MDR EU Medical Device Regulations 6
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
P EU MDR Translation of Product Name EU Medical Device Regulations 3
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1

Similar threads

Top Bottom