Staying In Compliance

Knowing when a products certification lapses

On average, most medium to large scale laboratory/industrial product manufacturers conduct certification with reasonable due diligence during a products release. Unfortunately, however, there are many companies that let the products certifications lapse over time and become outdated. (i.e. This happens when directives, regulations and/or compliance standards update but the products documentation never reflects this new release date for said directives, regulations or compliance standards.) This lapse in updated certification can happen for various reasons, but this article will focus on the legal obligation as to why updated compliance is necessary.

If we reference the European Union’s Low Voltage Directive (2014) for electrical equipment you will see the following statement relating to manufactures responsibilities;

 “4.   Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive. Changes in product design or characteristics and changes in the harmonized standards referred to in Article 12, the international or national standards referred to in Articles 13 and 14, or in other technical specifications by reference to which conformity of electrical equipment is declared shall be adequately taken into account.”

The above statement means that a Legal Manufacturer must take the necessary steps to keep the product certification updated to the latest Directive (law), or Standard (harmonized process to comply with said law). In other words, if the directive has updates with new requirements, or the standard has been changed to a new release date, the changes should be reviewed. In most cases the product should be re-evaluated to meet the latest requirements. There is a transition period to conduct this work, but it is not recommended to delay until last minute as this will only cause additional issues. 

“8.   Manufacturers who consider or have reason to believe that electrical equipment which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that electrical equipment into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the electrical equipment presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the electrical equipment available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.”

The above statement is fairly clear. Legal Manufacturers should understand that not correcting the issue can cause serious implications such as pulling product from the market, notifying member states, or criminal proceedings with fines and recalls.  When a noncompliance is found internally, there needs to be actions taken to rectify the problem.

If we turn our attention to the United States, you will see that electrical regulations are laid out in CFR 1910. Products must show compliance to all the relevant clauses. In section 1910.5(f) of the CFR you will find the following;

“An employer who is in compliance with any standard in this part shall be deemed to be in compliance with the requirement of section 5(a)(1) of the Act, but only to the extent of the condition, practice, means, method, operation, or process covered by the standard.”

Similar to the directives in the European Union, The Code of Federal Regulations for the United States declares that consensus standards can be used to show compliance to the applicable laws. It should be noted however that a product may require compliance to more than one standard in order to address the products full “Intended Use” and/or reasonably foreseeable hazardous situations.

One difference you may notice is that the European Union has fairly clear guidelines for keeping a products certification updated based on the latest directives and standards (“Grandfathering” is not a generally accepted practice). On the contrary, the United Sates does not seem to have a clear requirement which forces manufacturers to evaluate the product to the latest iteration of the standard. With that said however, there is still a strong need to do so.  

If a manufacturer can prove that a product has not changed enough to affect the test results received during the certification process, updating to the latest compliance requirements may not be necessary in the United States. It should be noted though that electrical products are made up of many components; sometimes hundreds or thousands. Can a manufacturer say for certain that none of those components have changed due to “end of life” issues? If the component has changed, does it have the exact same specifications and error ratings? Is it made of the same materials or by the same process? Although these concerns may be small by themselves, many of these changes can add up over time. After ten years, an electrical product may be produced with 50% of its original components replaced. Can a manufacturer still reasonable claim that products being produced today is the same as it was ten years ago? Is the cost savings of not keeping compliance updated worth the risk? These are all questions a manufacturer needs to be comfortable answering. 

Therefore it is so beneficial for products to utilize a National Recognized Testing Laboratory (NRTL) under the Occupational Safety and Health Organization (OSHA) in the United States. Not only will these organizations audit the products production line for component changes, but they will also send  Update Notifications when standards change. This notification and product feedback loop can drastically reduce risk and liability when it comes to global sale. Furthermore, it’s a legal requirement under CFR 1910.7. In comparison, a CE marked product is not reviewed or audited by anyone and can easily be out of compliance if the regulatory professionals are unaware of the latest requirements.

Sources & Literature (if any):

https://www.osha.gov/laws-regs/regulations/standardnumber/1910
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0035

Author: Brett

Brett Gagnon is currently one of the global subject matter expert for electrical equipment and electrical medical devices at Merck KGaA Darmstadt Germany, otherwise known as Millipore Sigma within North America. He has an Electrical Engineering degree from Wentworth Institute of Technology and a Masters of Business from Southern New Hampshire University. Mr Gagnon has a background in the ATIC (Assurance Testing Inspection Certification) industry based on previous years working for Intertek Testing Services NA Inc out of the Boston Ma area. During his time at Intertek he became a CB certified engineer evaluating products to medical, laboratory, IT, and Industrial standards. He also has a knowledge base in laser, Ingress Protection testing and wireless radio registration. Additionally Mr. Gagnon was a Field label and Special Inspection agent reviewing large custom equipment for national safety approvals in North America.

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