July 2024
Introduction to CE Mark and Regulatory Updates
The CE Mark, standing for Conformité Européenne, is a crucial certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). It allows manufacturers to freely market their products within this vast economic zone without further compliance assessments in each member state. To maintain its effectiveness and relevance, the regulatory framework governing the CE Mark undergoes continuous updates to adapt to technological advancements, new safety concerns, and evolving global standards.
Evolution of CE Mark Regulations
The journey of CE Mark regulations began with the establishment of the European Union (EU) and the need to harmonize product safety standards across member states. Initially introduced in 1985, the CE Marking process aimed to create a unified market while ensuring high levels of consumer and environmental protection. Over the years, the scope and requirements of CE Marking have expanded to cover a wide range of products, from medical devices to machinery, electronics, and personal protective equipment.
Recent Regulatory Updates
1. Medical Devices Regulation (MDR)
One of the most significant updates to CE Mark regulations is the implementation of the Medical Devices Regulation (MDR), which came into full effect in May 2021. The MDR replaces the previous Medical Devices Directive (MDD) and introduces stricter requirements for medical device manufacturers. Key updates include:
Classification System: Revised classification rules based on potential risk and intended use.
Post-Market Surveillance: Enhanced requirements for monitoring devices after they enter the market.
Clinical Evidence: Strengthened requirements for clinical data and evidence.
Unique Device Identification (UDI): Introduction of UDI to improve traceability.
These changes aim to enhance patient safety, streamline market access, and adapt to technological advancements in medical devices.
2. In Vitro Diagnostic Regulation (IVDR)
Similar to the MDR, the In Vitro Diagnostic Regulation (IVDR) replaces the previous In Vitro Diagnostic Directive (IVDD) and sets out new requirements for in vitro diagnostic medical devices (IVDs). Key updates include:
Risk-Based Classification: Updated classification criteria based on risk.
Performance Evaluation: Stricter requirements for performance evaluation and clinical evidence.
Market Surveillance: Enhanced post-market surveillance obligations.
UDI and Traceability: Introduction of UDI for better traceability and transparency.
The IVDR aims to ensure the safety, performance, and reliability of in vitro diagnostic medical devices while promoting innovation in the field.
3. EU Machinery Directive
The EU Machinery Directive (2006/42/EC) sets out essential health and safety requirements for machinery and equipment placed on the EU market. Recent updates focus on:
Emerging Technologies: Guidance on integrating emerging technologies like AI and IoT into machinery.
Safety of Machinery: Strengthened requirements for risk assessment and safety measures.
Documentation and Compliance: Clearer documentation requirements to demonstrate compliance with safety standards.
These updates aim to address new technological challenges and enhance workplace safety across industries.
4. EU RoHS Directive
The Restriction of Hazardous Substances Directive (RoHS) restricts the use of certain hazardous substances in electrical and electronic equipment (EEE). Recent updates include:
Scope Expansion: Broadening the scope to include more product categories.
Substance Restrictions: Tightened restrictions on substances such as lead, mercury, and cadmium.
Circular Economy: Emphasis on promoting the circular economy by improving resource efficiency and recycling.
These updates aim to reduce environmental impact and protect human health by restricting hazardous substances in electronic products.
5. EU REACH Regulation
The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation is a comprehensive regulation governing the production and use of chemicals in the EU. Recent updates include:
Substance Evaluation: Expanded substance evaluation process to identify and manage risks.
Candidate List: Regular updates to the Candidate List of substances of very high concern (SVHCs).
Authorization Requirements: Stricter requirements for substances requiring authorization.
These updates aim to improve chemical safety, protect human health, and enhance the competitiveness of the EU chemicals industry.
Implications and Challenges
1. Impact on Manufacturers
Manufacturers must navigate complex regulatory landscapes, invest in compliance efforts, and adapt to evolving standards. Compliance with updated CE Mark regulations requires substantial resources and expertise in regulatory affairs.
2. Market Access
CE Marking remains a gateway to the EU market, providing manufacturers with access to over 500 million consumers. Compliance with updated regulations ensures market acceptance and consumer trust.
3. Global Harmonization
CE Mark regulations often influence global standards, encouraging alignment with international regulatory frameworks and promoting global market access for compliant products.
4. Challenges and Compliance Issues
Challenges include interpretation of complex regulatory requirements, resource constraints for smaller manufacturers, and potential delays in market entry due to compliance issues.
Here are the specific directive numbers for the last three changes to the CE Mark regulations:
Medical Devices Regulation (MDR) - Directive 2017/745/EU
The MDR replaces the Medical Devices Directive (MDD) and sets out updated requirements for medical devices within the European Union. It came into full effect on May 26, 2021.
In Vitro Diagnostic Regulation (IVDR) - Directive 2017/746/EU
The IVDR replaces the In Vitro Diagnostic Directive (IVDD) and introduces updated requirements for in vitro diagnostic medical devices (IVDs). It also came into effect on May 26, 2022, with a transitional period for some requirements.
Radio Equipment Directive (RED) - Directive 2014/53/EU
The RED sets out essential requirements for radio equipment placed on the EU market. It aims to ensure the efficient use of the radio spectrum, electromagnetic compatibility (EMC), and protection of health and safety related to exposure to electromagnetic fields (EMF).
These directive numbers are crucial identifiers for understanding and complying with the specific regulatory requirements outlined in each respective directive under the CE Mark framework.
Future Outlook
Looking ahead, CE Mark regulations are expected to continue evolving in response to technological advancements, emerging safety concerns, and global regulatory developments. The EU's commitment to enhancing product safety, environmental protection, and market competitiveness will drive further updates and revisions to CE Mark regulations.
Conclusion
In conclusion, recent regulatory updates for CE Mark reflect the EU's commitment to enhancing product safety, environmental protection, and market competitiveness. From medical devices to machinery and electronic equipment, updated regulations aim to ensure high standards of consumer protection while promoting innovation and market access. Manufacturers must stay informed about these updates, invest in compliance efforts, and navigate the evolving regulatory landscape to successfully market their products within the EU and beyond.
May 2024
Before Brexit, many products placed on the United Kingdom (UK) market were required to comply with the European Union (EU) directives and bear a CE mark (from the French conformité européenne meaning "European conformity") to demonstrate compliance with these directives.
After Brexit, the UK had implemented new regulations as a replacement for the EU directives. The UKCA (UK Conformity Assessed) mark was introduced as the new compliance mark for the UK market. The UK implemented a transition period ending on 31 December 31 2024, giving manufacturers and importers time to implement the new UK regulations into their business operations.
On 24 January 2024, however, the UK government announced that it intends to legislate to continue recognition of EU requirements, including the CE marking, indefinitely for a range of product regulations this spring 2024.
During a meeting on 6 February 2024 between the NIST Office of Weights and Measures (OWM) and the UK Weighing Federation (UKWF), Mr. Turner from the UKWF confirmed that if the recognition of the CE marking is indeed adopted in the UK legislation, U.S. manufacturers can place these products on the UK market if these products meet the EU directives and bears a CE marking. This includes weighing and measuring instruments used for legal metrological applications.
Medical devices that fall under the EU Medical Device Regulation are excluded from the recognition of EU requirements.
March 2024
The Commission has today adopted a Recommendation to combat counterfeiting, both offline and online, and enhance the enforcement of intellectual property rights (IPR). The Recommendation, also known as the EU toolbox against counterfeiting, aims to foster collaboration between rights holders, service providers, and law enforcement, while encouraging best practices and the use of modern tools and technologies. It consists of strategic initiatives to combat counterfeiting and strengthen the enforcement of intellectual property rights, setting out dedicated tools to increase companies' resilience and ability to better protect their intangible assets, including against cyber-theft.
Key actions proposed by the Commission in its Recommendation include:
Designating a single contact point for IP enforcement matters and extending the use of existing tools, such as the IP Enforcement Portal made available by the EU Intellectual Property Office (EUIPO).
Encouraging signatories to the Memorandum of Understanding on the sale of counterfeit goods on the internet to seek ‘trusted flagger status' under the Digital Services Act, thereby ensuring that they are given priority when submitting any notices of illegal content. Signatories and other intermediaries' services providers are encouraged to participate in the modernisation of the Memorandum of Understanding.
Adapting procedures to counter new counterfeiting practices, addressing issues like mirror websites with dynamic injunctions, optimising information sharing in court proceedings, and ensuring appropriate compensation for damages, including both material and moral damages.
Promoting the use of alternative dispute resolution for all IP disputes, offering a cost-effective and efficient option, especially for cross-border disputes and SMEs.
Reassess and potentially increase the maximum sanctions on serious criminal IP offences.
Empower market surveillance authorities to further detect and combat counterfeiting.
Develop practices aiming at faster, cheaper, and more ecological storage and disposal of counterfeits.
Adapting IP practices to AI and virtual worlds, using blockchain for supply chain traceability and content recognition systems to detect counterfeiting and pirated goods.
Integrating IP content in national training and education curricula, especially for law enforcement and business studies.
Key tools proposed by the Commission in its Recommendation, especially addressed to SMEs:
Under the SME Fund, a Commission initiative implemented by the EUIPO, a new service called “IP scan enforcement voucher” reimburses the costs incurred by SMEs that seek initial advice by experts on how to enforce their rights in case of an IP infringement or how to avoid infringing another company's IP rights.
A Cybertheft Prevention Toolkit, providing awareness-raising materials and trainings, will be developed by the Commission. This will help SMEs prevent or react to cyber-attacks (e.g. hacking) against trade secrets.
A checklist with guidance on how SMEs can use AI without compromising their intangible assets will be developed by the Commission in close cooperation with the industry and Member States.
Next Steps
The Commission, together with the EUIPO, will closely monitor the effects and implementation of this Recommendation. On this basis, the Commission will assess the effects of the Recommendation within three years from the adoption. The Commission will then decide whether additional measures are needed at EU level, in view of technological developments and of the outcome of the ongoing enforcement study that the Commission is carrying out. The assessment will also look at any impact the implementation of the Digital Services Act and Recommendation on combating online piracy of sports and other live events may have had on the enforcement of IPR.
Background
The Recommendation follows up on the 2020 Intellectual Property Action Plan, where the Commission undertook to enhance IP enforcement, by adopting the Digital Services Act and by establishing a toolbox against counterfeiting, which will be adopted with this Recommendation.
The Recommendation published today builds on the results of a broad consultation exercise partly facilitated by the EUIPO through the EU Observatory on Infringements of IP Rights, which included several stakeholder workshops in 2021 and 2022, a Call for Evidence, a high-level roundtable hosted by Commissioner Thierry Breton in June 2022 and expert group meetings as well as the International IP Enforcement Summit held in June 2023.
IP rights play a significant role in the EU's economy, with activities involving IP constituting almost 50% of the EU GDP and providing nearly 40% of employment. Unfortunately, counterfeiting and piracy have become pressing concerns, undermining investments and innovation for EU companies and posing risks to consumers and the environment. SMEs are particularly vulnerable in this landscape and are far more likely to fail as a result of IPR violations than larger companies.
Counterfeiting is an issue that goes beyond luxury goods and has impacted products ranging from everyday goods such as food, cosmetics, and textiles to essential spare parts for wind turbines, trains and aeroplanes. In 2019, counterfeit products represented nearly 6% of all EU imports, reaching EUR 119 billion in value and leading to an estimated loss of 670.000 direct jobs and EUR 15 billion in lost tax revenue.
January 2023
EC amends standards Low Voltage Directive 2014/35/EU – January 11, 2023 –
The European Commission amends the list of harmonised standards under the Low Voltage Directive as regards the harmonised standard for lamp controlgear, luminaires, climatic and environmental testing and other temperature conditioning equipment and power metering and monitoring devices.
Do you have applied standards to prove compliance in regard to the mentioned regulations? We recommend you to check the new list of standards to see if any of the standards you applied have been updated. If so, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity.
June 2023
On 29 June 2023, the European Commission published the new Machinery Regulation 2023/1230. This regulation replaces the Machinery Directive (2006/42/EC). The Machinery Regulation lays down the requirements and conformity assessment procedures that machinery has to fulfill before they are allowed to be sold or used in the European Union market.
CE Marking Updates
International Type Approval and Safety Approval
CE stands for Conformité Européenne, which is French for "European conformity". CE approval, also known as CE marking, is a regulatory standard that verifies that a product has met the health, safety, performance, and environmental requirements of the European Union (EU). CE approval allows products to be sold and marketed throughout the EU, as well as in 32 other countries with a population of almost 500 million.
Contact CSIA for more information on these updates or on obtaining a CE Certification for your product.