Iso 15223-1 Pdf 2021

[Melchior Dow]

Answersto the questions listed in this article have been provided by the presenter of this webinar, Leo Eisner, who was involved in the revision process of the ISO 15223-1:2021 Fourth Edition. In addition, all responses have been vetted by multiple subject matter experts as well as those who are most familiar with the international standard for the application of medical device symbols on labels.

It depends on when the applicable national regulator adopts the standard. The standard itself has no transition date noted as ISO doesn't allow publication of a transition date. No national regulators have adopted the ISO 15223-1 standard yet as it was just published by ISO on July 6, 2021.

So, the transition period for each national regulator has not been identified yet and we will have to wait to see what is determined by each national regulator. Expect either the US or the EU will be the first countries to adopt the standard through their national standards bodies.

The EU MDR General Safety and Performance Requirements (GSPR) 23.1 (h) indicates: "the information supplied by the manufacturer shall take the form of internationally recognised symbols". Hence using such symbols in Europe is mandatory. This is independent of listing a standard in the Official Journal of the European Union (OJEU).

Note, that the standard will be added to the Recognized Consensus database (db) first to get into the manufacturers hands as soon as possible and then published in the Federal Register sometime later, as that is the normal process that the FDA has been doing for the last couple years.

The date of ratification (DOR) by CEN was July 4, 2021, for the EN ISO 15223-1 version of the standard and it is considered equivalent to the ISO 15223-1 other than the Annex Z's & the European Forward will be included in the EN version of the standard when the standard is Harmonized.

The CEN db shows that the standard has been approved (Sept 9, 2021). EU Member States now have six months (til March 31, 2022) to implement (Date of Publication) the ratified text as their own national standard. You should be able to purchase a copy of the EN version of the standard from any CEN member body by this date.

Do remember, that Europe no longer lists a transition period when standards are listed in the OJEU. The DOCOPOCOSS (Date of Cessation of Presumption of Conformity of Superseded Standard) has been deleted from OJEU listings. Further, since there were no standards listed on the final date of application of the MDR (May 26, 2021), all listings in the OJEU are immediately effective.

The standard is voluntary, and it is based on the context of national regulations. If you, the manufacturer, decides to apply the symbols in the standard it will help to reduce the burden of translation in your labeling. This response applies to many of the questions in this list.

A good way to think about the voluntary use of symbols, unless required by a national regulator, is that a medical device manufacturer may choose in the following priority order (highest to lowest order):

The benefit of using symbols from ISO 15223-1 is that the symbols have been validated for understanding by the target group of medical device users (patients and clinicians, nurses, etc.) and the intent is to support national regulatory requirements such as the EU MDR / EU IVDR when the standard has been listed in the OJEU.

Yes, the previous 3rd edition (2016) is now withdrawn by ISO and has been replaced by the 2021 4th edition. However, it depends on the national regulator when and how they transition to the new edition of the standard and if they expect "State of the Art" (as it is commonly known under European Regulations).

Remember, using standards is voluntary. Currently, ISO 15223-1:2021 is not an FDA Recognized Consensus Standard but will be and there will be a transition period adopted for it to be determined by FDA.

I would highly recommend adopting these symbols for your medical devices as soon as possible as these symbols were designed by consensus of an international group of standards developers; they simplify the label of your product. The developers of the standard include manufacturers, regulators, consultants, and other interested parties.

The FDA was involved in the development of a wide variety of standards, including this specific one. They have been involved in the process, commented on the various stages of drafts, voted on the drafts, and are quite aware of these changes.

At a minimum, I would consider planning a strategy for when you will adopt the symbols in the standard for your US FDA submissions, but please pass this approach by your regulatory affairs personnel or consultant to make sure it meets your product regulatory strategy.

After many discussions and the review of multiple comments by the ISO/TC 210 working group WG3, no better option came up during the development of the standard applicable to the broad range of medical devices that the symbol covers.

A model number can represent a product family or cover multiple catalogue numbers. At least one is required. Some manufacturers place both on the medical device labeling, depending on their product numbering structure.

Due to space limitations and with so many countries requiring more and more labeling these days I would recommend sticking to one of these identifiers, if possible. Below are more specific details found in ISO 20417:2021.

Catalogue number (3.3): value given by the manufacturer to identify a specific medical device or accessory as it relates to its form/fit, function and process (i.e., manufacturing processes requiring differentiation for the end user)

Model number (3.17): letters, numbers or a combination of these assigned by a manufacturer to distinguish by function or type, a particular medical device, accessory or medical device family from another

Since the prefilled syringes may be considered part of the medical device combination product depending on the regulatory classification, I would recommend you ask your regulatory affairs personnel or consultant to make that determination, but I would assume that the answer is YES this standard would apply for the applicable symbols needed.

The standard is written that the UDI is optional, but it is dependent on the national regulator if they will require the symbol. I would suggest that it would be wise to always use the symbol going forward, since products tend to have more than one barcode/QR code on a product and not all of them are UDI carriers.

The basics of risk management are based on a tiered priority system of risk control measures where the highest level is what you should strive for and the bottom level of this priority list should be your last resort risk control measure:

This is identified in clause 7.1 of ISO 14971:2019. The rationale for priority of order is noted in Annex A.2.7.1 of the standard which are derived from ISO/IEC Guide 63:2019, Guide to the development and inclusion of aspects of safety in international standards for medical devices, and IEC TR 60513, Fundamental aspects of safety standards for medical electrical equipment.

It should be added to your table of defined symbols in your device IFU, when for example you know your distributor will be using the symbol the IFU that they have translated (or had translated). This symbol is not used for translated information that was controlled by the manufacturer.

The translation symbol (5.7.8) is for entities responsible for the translation activities (such as the Importer, Distributor, dealer) not the manufacturer. This is to identify that the translated information was not provided by the manufacturer, and not a modification of the device. The symbol was introduced to meet the MDR requirement below.

Based on paragraph (3) of Article 16 of the EU MDR a distributor or importer that translates as mentioned in point (a) of paragraph (2) shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device (this could be the IFU), the activity carried out together with its name, registered trade name or registered trademark, registered place of business and the address at which it can be contacted, so that its location can be established.

Each regulatory authority may impose different requirements on who they want to disclose to identify translated information. Please confirm with each regulatory authority what those requirements may be as they may vary significantly per country.

Use the Caution symbol (5.4.) to raise awareness to avoid an undesirable consequence (a hazard, hazardous situation, etc.) to indicate use caution when operating the device or operator action to avoid an undesirable consequence.

You would provide a proposal on an ISO comment form. The NMB will discuss and forward the comments from their NC that they agree on to the ISO committee ISO/TC 210/WG3 for discussion and balloting during the development of ISO 15223-1.

Another option is to informally propose a symbol to add to ISO 15223-1 by sending a note to the convenor of ISO/TC 210/WG3, Symbols and nomenclature for medical devices, Lena Cordie-Bancroft or through the RAPS Regulatory Forum Exchange - RegEx forum if you're a RAPS member or through the ISO platform for the ISO/TC210 WG3.

Additionally, as presented recently at an MD&M West presentation, you can propose a symbol for the next edition of the standard. If you would like to propose a new symbol idea for the standard follow the process documented in ISO 15223-2 that is summarized as:

The presentation covered the major changes to ISO 15223-1:2021 from 2016. Each company will need to do their own gap analysis to determine which requirements will apply to their products / product lines / level of packaging.

Some are probably covered by these symbols standards mentioned above already but there may be other device specific standards that may have additional symbols and maybe even guidance documents and national standards that apply. You will have to do a specific gap assessment for your device to determine these symbols.

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