How to easily follow the EU harmonised standard updates. Resources you need to know.

Following EU harmonised standards can be tough for businesses, especially if you’re exporting to Europe. But, knowing the key sources and processes helps. This way, you can keep up with changes and make sure your products are up to code¹.

Contents

Harmonised standards are made by European Standards Organisations like CEN, CENELEC, or ETSI. They’re made when the European Commission asks for them¹. These standards help manufacturers and others show they meet EU laws. You can find these standards in the Official Journal of the European Union (OJEU)².

Key Takeaways

Harmonised standards are developed by CEN, CENELEC, and ETSI, the three officially recognised European Standardization Organizations (ESOs)².
About 20% of all European standards are developed following a standardization request from the European Commission¹.
Harmonised standards provide a harmonised way for businesses to demonstrate compliance with relevant EU legislation².
The references of harmonised standards are published in the Official Journal of the European Union (OJEU)².
Standards help to protect the environment and consumer health by providing measurement methods and test methods¹.

Understanding Harmonised Standards

Harmonised standards are key in the European regulatory scene. They are European standards made by European Standards Organisations (ESOs) like CEN, CENELEC, and ETSI. They were asked to do so by the European Commission³. These standards help with the EU’s laws and make sure products meet legal standards³.

What are Harmonised Standards?

Harmonised standards are technical rules for products, services, and processes. They help with EU laws³. These rules cover many areas, like chemicals, construction, and healthcare engineering³. In healthcare engineering, they focus on medical devices and implants³.

The Role of European Standards Organizations

Organisations like CEN, CENELEC, and ETSI are key in making harmonised standards³. They create technical specs that show products meet EU laws³. Making these standards is optional, but some laws might ask for them to be used³. Sometimes, a Commission standardization request is needed for them to be official³.

“The European Commission takes decisions based on formal objections raised against the publication of references of harmonised standards in the OJEU.”

The rules around harmonised standards are complex. The New Legislative Framework (NLF) and the Eco-Management and Audit Scheme (EMAS) help with checking and managing these standards³.

Importance of Following EU Harmonised Standard Updates

Keeping up with the latest EU harmonised standards is key for businesses. It helps them stay in line with EU laws and keeps their products safe and of high quality⁴. These standards prove that products, services, or processes meet EU law’s technical needs, offering a safe start⁵. By sticking to these standards, companies build trust with customers, making them feel safe and confident in what they buy⁴.

Compliance with EU Legislation

Following harmonised standards is vital for showing you meet EU laws⁵. The New Approach started in 1985 to fix the problem of different technical specs across EU countries. It helped make moving goods within the EU smoother⁵. Companies like these standards because they make it easier to follow EU rules, giving them a boost in meeting legal requirements⁵.

Enhancing Product Quality and Safety

Sticking to harmonised standards does more than just follow EU laws. It also makes products better and safer⁶. These standards cover many areas, like industrial trucks and machinery, offering a solid guide for making and keeping products safe⁶. By matching up with these standards, companies show they care about making quality and safe products. This builds trust with customers and makes them happy⁴.

Standard	Description
EN 12895 Industrial Trucks – Electromagnetic Compatibility	Harmonised standard listed under the EMC directive
EN ISO 12100 Safety of Machinery – General Principles for Design – Risk Assessment and Risk Reduction	Well-known harmonised standard under the Machinery directive

There are three kinds of harmonised standards for machinery: A-type, B-type, and C-type. Each one plays a role in making sure products are safe and of good quality⁶.

Harmonised standards

“Adherence to harmonised standards not only ensures compliance with EU laws but also enhances the quality and safety of products.”

Official Sources for EU Harmonised Standard Updates

The official source for the latest on harmonised standards is the⁷ Official Journal of the European Union (OJEU). You can find the latest lists of these standards on the OJEU website. It also includes other European standards published in the journal.

Harmonised standards help meet EU rules like the Medical Devices Regulation (MDR) or In Vitro Diagnostic Devices Regulation (IVDR)⁸. About 20% of European standards are made by the European Commission and are harmonized. They are listed in the Official Journal of the European Union.

⁸ Usually, the main text of a standard doesn’t change when it becomes a European harmonized version. It might have Annexes Z that explain how it meets regulations. But, there could be delays in making new international standards harmonized in Europe. This might leave gaps between the latest standards and what’s officially recognized.

⁸ Using harmonized standards in the EU is advised. But, if there are widely accepted international standards not yet harmonized, they can also be used⁸. ISO 16142-1:2016 and ISO 16142-2:2017 offer guidance on picking standards for medical devices. They list standards that ensure safety and performance.

Annex XVI Section	Products Covered
Section 1	Contact lenses⁷
Section 2	Products meant for surgical implantation into the human body for anatomical changes⁷
Section 3	Items for facial or dermal filling via injection⁷
Section 4	Equipment for reducing fat, like liposuction devices⁷
Section 5	High-intensity electromagnetic radiation equipment for skin treatments like tattoo removal⁷
Section 6	Devices for brain stimulation using electrical currents or magnetic fields⁷

Annex XVI doesn’t cover some products, like tattooing, piercings, or active implantable devices⁷. It also leaves out equipment using infrared for warming, sunbeds, and treatments for moles and other skin conditions⁷. Invasive brain stimulation devices are not part of Annex XVI either⁷.

EU Standards Bodies and Technical Committees

The European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI) lead in making standards for the EU⁹. These EU standards bodies work with industry and others to make standards that help follow EU laws⁹.

European Committee for Standardization (CEN)

CEN is a key European Standards Organization (ESO) that makes standards for many areas, like medical devices and construction¹⁰. When CEN makes a European Harmonized Standard, it stops making a national standard in that country⁹.

European Committee for Electrotechnical Standardization (CENELEC)

CENELEC focuses on electrotechnical standards¹⁰. Using Harmonized Standards is up to the manufacturer, but it helps meet the law⁹.

European Telecommunications Standards Institute (ETSI)

ETSI works on global standards for tech like 5G and cybersecurity¹⁰. The European Commission helps small EU companies and groups join in standard-making⁹.

Standards Body	Harmonized Standards Focus
CEN	Many sectors, including medical devices and construction
CENELEC	Electrotechnical industry
ETSI	Information and communications technologies

The EU’s standards reach beyond its borders to include members and groups from other countries⁹. In February 2022, the European Commission shared its standardization strategy to boost the EU’s global competitiveness⁹.

“Harmonized standards are key for CE marking, offering a way to show you meet EU laws.”

sources to follow for eu harmonised standards updates

It’s vital for businesses and professionals in regulated fields to keep up with EU harmonised standards updates. Following key sources is essential for this¹¹.

One top source is the Official Journal of the European Union. Here, the European Commission shares the references of harmonised standards with everyone¹¹.

Also, check out the websites of European Standards Organisations. Look at the European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC), and European Telecommunications Standards Institute (ETSI). They work on the standards that help follow EU laws¹¹.

Don’t forget about industry publications and newsletters. They offer the latest news, analysis, and comments on standardisation. This helps you stay ahead¹¹.

By watching these sources, you make sure your business knows about the newest EU harmonised standards. This helps you keep up with laws and stay competitive¹¹.

“Staying informed about EU harmonised standards updates is crucial for businesses and professionals to ensure compliance and maintain a competitive edge.”

In short, the main sources for EU harmonised standards updates are the OJEU, European Standards Organisation websites, and industry publications. Using these, you can keep your business informed and ready for changes¹¹.

EU Standards Publications and Databases

The European Standards Organisations, like CEN, CENELEC, and ETSI, offer many online tools and databases. They help you keep up with the latest EU standards¹². You can easily find and read the full text of standards, making sure your products follow the law¹².

CEN and CENELEC Online Libraries

The CEN and CENELEC online libraries are huge digital collections of European standards¹². You can search, view, and download the newest harmonised standards for your industry. This ensures your products meet EU standards¹².

ETSI Standards Search

The ETSI Standards Search is key for telecommunications standards¹². It lets you quickly find and access the standards you need. This makes following the law easier and keeps you ahead in the fast-changing telecom world¹².

Using these EU standards publications and databases makes dealing with harmonised standards easy. It keeps you informed and ready for the European market’s changes¹². Spending time on these resources can save you time, money, and make sure your products are ready for the market and follow the law¹².

Staying Up-to-Date with EU Standards News

It’s vital for medical device companies to keep up with EU standards. To do this, subscribing to RSS feeds and notifications from European Standards Organisations and industry sources is key. Newsletters, email alerts, and social media updates can keep you in the loop about new standards, changes, and more.

RSS Feeds and Notifications

Getting updates through RSS feeds and notifications is an easy way to keep up with EU standards news¹³. These sources give you real-time news on changes to standards and lists in many languages. By following these updates, your company can quickly adjust its compliance plans.

Official channels and industry publications are also great for staying informed¹⁴. They offer deep analysis and insights on EU standards. This helps medical device companies understand and handle the changes better.

“Keeping up with EU standards news is key for medical device companies. It helps them stay compliant and keep their products safe and quality. Using RSS feeds and notifications from trusted sources keeps companies ready for regulatory changes.”

By always checking these sources and adding new info to your quality system, you can keep up with EU standards news and notifications. This helps you stay ready for changes in the regulatory world.

EU Standards Consultations and Initiatives

The European Standards Organisations often hold public consultations and start initiatives. They aim to get feedback from stakeholders on new or updated standards¹⁵. By taking part, you can make sure your views and industry worries are heard.

Rare Cancers Europe (RCE) has taken part in recent consultations. For example, they gave feedback on medicines for humans, with a new law expected in late 2022¹⁵. RCE worked with many groups, like scientific bodies, patient groups, and healthcare providers, through its Steering Committee¹⁵.

RCE has shared its thoughts on laws that encourage making medicines for kids and rare diseases. They want to make getting these medicines easier and faster¹⁵. They also suggested making health technology assessment processes the same across Europe to speed up rare cancer medicine access¹⁵.

When talking about the European Health Data Space, RCE said it’s key for people to control their health data. They also called for more investment in digital tools and systems¹⁵. In looking at the Cross-border healthcare Directive, RCE pointed out the need for clear info on costs and rules for getting healthcare. They pushed for a unified platform and more awareness on healthcare access¹⁵.

In the Europe’s Beating Cancer Plan consultation, RCE pushed for rare adult cancer to be part of national cancer plans. They also suggested more money for European Reference Networks (ERNs) for rare adult cancers¹⁵.

These examples show how groups can work with the European Standards Organisations. By joining in on consultations and initiatives, businesses and groups can make sure their needs and worries are considered in making standards¹⁶¹⁷.

Conclusion

It’s key for businesses and groups to keep up with EU standard updates. This helps them follow the law and make sure their products and services are safe and quality. By using official sources, publications, and databases, and signing up for news services, you can keep track of EU changes¹⁸. This helps you update your products and services smoothly to fit new laws, like the Medical Device Regulation (EU) 2017/745¹⁸.

Keeping an eye on EU standards and joining in on technical committees helps your organisation stay flexible and ready for new rules¹⁹. Knowing the latest updates and best practices lets you lead in following the law and innovate in your field²⁰.

This article shows how important it is to stay updated with EU standards. Using the tips and resources given, you can confidently handle the complex rules. This ensures your business does well for a long time²⁰.

FAQ

What are Harmonised Standards?

Harmonised standards are European standards made by European Standards Organisations (CEN, CENELEC, or ETSI). They are made at the request of the European Commission. Companies, economic operators, or bodies that check conformity can use these standards to show they meet EU laws.

What is the role of European Standards Organizations?

The main European Standards Organisations (ESOs) are the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI). They work with industry and others to make standards. These standards help implement EU laws.

Why is it important to follow EU harmonised standard updates?

It’s key to follow EU harmonised standard updates to keep up with EU laws and ensure product quality and safety. Using these standards shows products meet EU technical needs. It also builds trust with consumers by showing quality and safety.

Where can I find official sources for EU harmonised standard updates?

The Official Journal of the European Union (OJEU) is the top place for the latest on harmonised standards. The OJEU website has the latest lists of these standards and other European standards.

What are the main EU standards bodies and technical committees?

The main groups making harmonised standards are the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI).

What are the best sources to follow for EU harmonised standards updates?

For the latest on EU harmonised standards, check official sources like the Official Journal of the European Union (OJEU) and the websites of European Standards Organisations (CEN, CENELEC, ETSI). Also, look at industry publications or newsletters for EU standardisation news.

What EU standards publications and databases can I access?

European Standards Organisations offer online resources and databases for harmonised and other European standards. You can find the full text of standards in the CEN and CENELEC online libraries. The ETSI Standards Search lets you search and download telecom standards.

How can I stay up-to-date with the latest EU standards news?

To keep up with EU harmonised standards news, subscribe to RSS feeds and notifications from European Standards Organisations and industry sources. This includes newsletters, email alerts, and social media updates on new standards, changes, and news.

How can I participate in EU standards consultations and initiatives?

European Standards Organisations often hold public consultations and initiatives to get feedback from stakeholders on standards. Joining these can help make sure your views and industry concerns are heard in the standards-making process.