EU Harmonized Standards with Restrictions: What Radio Equipment Manufacturers Need to Know

Harmonized standards with restrictions are RED standards listed on the EU Official Journal (OJEU) where one or more clauses carry no presumption of conformity. This Element whitepaper by wireless expert Michael Derby explains what a restriction means for your Declaration of Conformity, when it forces a Notified Body EU-TEC, and when the harmonized route stays open.  

This whitepaper by Element wireless expert Michael Derby explains what those restrictions mean, why the European Commission uses them, and how to judge whether your product needs a Notified Body EU-Type Examination Certificate. It draws on the restrictions attached to EN 300 440, EN 301 908-13 and EN 18031.  

 Key point: A restriction on the OJEU does not automatically mean you need a Notified Body. It means one or more clauses in that standard carry no presumption of conformity. If the restricted clause does not apply to your product, or you can design or test past it, the harmonized route stays open.  

 

What This Whitepaper Helps You Decide 

If a standard your compliance file depends on now carries a restriction, this whitepaper helps you:  

• Determine whether the restricted clause applies to your equipment at all.  

• Decide whether you can meet the stricter requirement rather than build a case against it.  

• Establish when a Notified Body EU-TEC becomes mandatory, and when it does not.  

• Record the reasoning correctly in your technical documentation and risk assessment.  

 

Understanding EU Harmonized Standards with Restrictions & Compliance Routes: Abstract 

This whitepaper explores the complexities of EU Harmonized Standards with restrictions and their impact on product compliance for manufacturers. It outlines when Notified Body involvement is necessary, the different routes to certification, and how to navigate these challenges. Learn practical steps to achieve CE marking and ensure seamless market access within the EU, minimizing regulatory risks and delays.  

 

Understanding Harmonized Standards with Restrictions: Excerpt  

“A standard listed with a restriction is a far better outcome for industry than a standard that is not listed at all. The Commission has told you, in public, exactly which clause it was not satisfied with, and everything else in that standard still gives you presumption of conformity. Compare that with a standard which never appeared on the Journal, where the manufacturer and the Notified Body are both left to work out what the objection was before either of them can move.”  

 — Michael Derby, Wireless Expert, Element Connected Technologies  

 

What a “Harmonized Standard” Means Under the RED  

The RED offers two routes to CE marking.   

1. Apply listed harmonized standards in full and you sign your Declaration of Conformity (DoC) on your own authority.
2. Apply unlisted standards, or a listed one only in part, and you may need a Notified Body EU-Type Examination Certificate first.  

 

Presumption of Conformity Comes from the OJEU Listing 

It is worth being precise about what “harmonized” buys you. ETSI and CENELEC routinely print the word on the front page of a standard, but that describes drafting intent and carries no legal effect. Presumption of conformity arrives only once the Commission has listed the standard for the RED, you have applied it in full, and any restriction has been satisfied.  

The distinction decides who carries the burden of proof. With presumption of conformity, a market surveillance authority has to demonstrate a problem. Without it, you justify why your assessment meets the essential requirements.  

 

Which RED Articles Trigger a Mandatory Notified Body  

Not every gap produces the same outcome, and this is where most of the confusion sits. If the standard used for Article 3.2, efficient use of the radio spectrum, or for any part of Article 3.3, including cybersecurity under 3.3(d), (e) and (f), is not listed or not fully applied, an EU-TEC is mandatory before the DoC can be signed.  

For Article 3.1(a) safety, Article 3.1(b) EMC and Article 3.4, incomplete application does not trigger that obligation. You still justify the assessment in your technical file, but the Notified Body route stays optional.  

One scoping point is worth budgeting for. Where an EU-TEC is required by a single restricted clause, the certificate covers every radio operation in the product.  

 

Why the European Commission Lists Standards with Restrictions  

The Commission inherits legal responsibility when it lists a standard, so a weak clause represents real risk. Industry wants standards listed quickly, and withholding one over a single clause penalizes everybody who needs it. Listing with a restriction is the compromise.  

Much of the recent scrutiny traces back to legal certainty, a principle meant to protect people from ambiguity in the law rather than a measure of technical quality. Picture a road with no posted limit, just a sign reading “drive only as fast as is safe.” Standards carry the same weakness whenever they let the manufacturer decide how thoroughly to test.  

 

The Two Types of Restriction on the RED OJEU 

There is no fixed format for restriction wording, but the examples published so far fall into two patterns.  

 

Restrictions on a Test Case That Applies to Only Some Equipment 

A cellular standard might sufficiently cover conducted antenna port measurements and spurious emissions while the over-the-air (OTA) performance test case is judged insufficient. If that OTA test only applies to handsets above a defined size, watches, tablets, IoT devices and radio modules are unaffected, and keeping the whole standard off the Journal would have penalized all of them.  

 

Restrictions on a Clause That Lets the Manufacturer Choose  

A short-range device standard may define three levels of receiver test severity and allow the manufacturer pick a category based on how critical the radio link is. A restriction can state that only the strictest level gives presumption of conformity, so testing to category 1 keeps the harmonized route open.  

EN 18031-1, used for Article 3.3(d), works the same way. It permits a device to ship without the user having to set a password, and the restriction removes presumption of conformity for that case, because two devices assessed identically would reach the market with different levels of protection. Require a password that is unique or user-set and cannot be disabled, and the standard is fully harmonized again.  

 

What Actions Should Manufacturers Take When a Standard Carries a Restriction? 

Read the restriction notice alongside the standard, then work through two questions in order.  

Does the restricted clause apply to my equipment? If not, document that and move on. If it does, can I meet the stricter requirement instead of disputing it? Testing to the harshest receiver category, or removing the option to disable a password, is usually quicker than a certification route. If neither helps, plan for an EU-TEC.  

Speed to market normally settles it. Meeting a requirement you would rather have avoided tends to cost less than several weeks spent arguing that you should not have to.  

 

How a Notified Body Reviews a Technical File with a Restricted Standard 

A Notified Body reviewing a technical file asks two questions:   

1. Were the correct tests, limits and methods selected?
2. Was the testing carried out accurately?    

Where a standard is listed without restrictions, the Commission has settled the first, so the review concentrates on the second.  

A restricted standard splits the file between the two. Unrestricted test cases get the lighter review; restricted ones get the full treatment, but with an advantage over a standard that was never listed, because the notice states publicly what the Commission considered inadequate.  

 

Frequently Asked Questions: RED Harmonized Standards with Restrictions 

Questions Element's advisory team is asked most often about restricted listings.  

 

Where is the RED OJEU published?  

There is no single permanent page. A new listing appears each time standards are added or amended, so the current position is the sum of several implementing decisions. The European Commission's harmonized standards page for radio equipment carries the latest references and a consolidated summary of everything published so far.  

 

Is there a third conformity assessment route under RED Annex IV?  

Yes. Annex IV, based on Module H, lets a Notified Body assess a manufacturer's full quality system rather than an individual product. It is rarely used, and it does not change how a restriction affects you.  

 

Does a Notified Body test the device when a standard carries restrictions?  

No. A Notified Body is never involved in testing a product. Where a restriction applies and you cannot avoid it, what is required is a review of your technical documentation, resulting in an EU-TEC.  

 

Do I need a separate Declaration of Conformity (DoC) for each Directive?  

No. One DoC covers every applicable EU Directive and Regulation. For most radio equipment, that single document covers the RED alongside others such as RoHS.  

 

Does the RED apply in addition to the EMC Directive and Low Voltage Directive?  

No. If a product is radio equipment, or contains a radio communication or radio determination function, the RED applies and the EMC Directive and Low Voltage Directive do not. That holds even where the radio comes from an installed CE-marked radio module.  

 

Can I use a standard listed under another Directive for RED Article 3.1?  

Not for presumption of conformity. A standard listed for the LVD, EMCD or MDR is not harmonized under the RED unless it also appears on the RED OJEU. EN 62368-1 is the common example: often the right safety standard, but it carries no presumption of conformity to the RED.  

 

Does the same apply in the UK?  

The UK maintains its own list of designated standards under the Radio Equipment Regulations 2017. Technical content is usually the same, but designation dates and any qualifications are set independently, and the UK route uses an Approved Body. Check both lists.  

 

Key Takeaways for Manufacturers Facing a Restricted Standard 

A restricted listing reads like bad news and usually is not. It identifies exactly which clause the Commission was unhappy with, leaves the rest of the standard intact, and normally leaves a clear path to presumption of conformity.  

More standards will be listed with restrictions, particularly in cybersecurity. Treating the notice as part of the standard, rather than as small print, saves considerable rework.  

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