RoHS July 2024 Deadline: Impacts, Exemptions & How to Prepare
The Restriction of Hazardous Substances Directive (RoHS) has been a base regulation in promoting environmental sustainability and ensuring the safety of electronic and electrical equipment (EEE) within the European Union (EU). However, navigating through its exemptions and deadlines can be a complex endeavor for manufacturers and consumers alike. With the upcoming July 21st, 2024 deadline looming, understanding the implications and frequently asked questions (FAQs) surrounding RoHS exemptions becomes paramount. The upcoming deadline of July 21st, 2024 for the exemptions marks a significant milestone in RoHS compliance. Some of the widely used exemptions within the industry are waiting for a decision by the commission. Manufacturers must ensure that their products comply with the latest restrictions and exemptions outlined in the directive by this date. Failure to comply may result in legal consequences and market access limitations within the EU. Impact: Compliance Challenges: Meeting the deadline requires thorough assessment and potentially redesigning products to substitute restricted substances with compliant alternatives. This can pose significant technical and financial challenges for manufacturers, especially for complex products with multiple components. Supply Chain Implications: Ensuring the compliance of the entire supply chain, including suppliers of components and materials, becomes crucial. Manufacturers need to collaborate closely with their suppliers to verify the compliance of sourced materials and components. Market Access: Equipment placed in the market before July 21st, 2024 can remain on the market. Even beyond the deadline existing exemptions will remain valid until the commission takes a decision on the renewal application. Environmental Impact: RoHS compliance contributes to reducing the environmental footprint of EEE by minimizing the use of hazardous substances and promoting the adoption of eco-friendly alternatives. The deadline underscores the EU’s commitment to environmental sustainability and drives innovation in green technologies. RoHS Exemptions Beyond July 21st, 2024 Industry Preparedness Preparation for the July 2024 deadline involves proactive steps by manufacturers, regulators, and industry stakeholders: As the July 21st, 2024 deadline for RoHS compliance approaches, manufacturers must prioritize understanding and adhering to the latest regulations and exemptions. Navigating through the complexities of RoHS requires proactive engagement, collaboration, and a commitment to environmental sustainability. By embracing compliance, manufacturers can not only ensure market access but also contribute to a safer and greener future for electronic and electrical equipment worldwide. FAQs: 1.What happens if a product is found to be non-compliant after the deadline? Non-compliant products may be subject to corrective actions, including recalls, fines, and restrictions on market access within the EU. It’s essential for manufacturers to prioritize RoHS compliance to avoid such consequences. 2. Will RoHS regulations continue to evolve beyond the July 21st, 2024 deadline? Yes, RoHS regulations are subject to periodic revisions and updates to align with technological advancements and emerging environmental concerns. Manufacturers should stay informed about upcoming changes to ensure ongoing compliance.
RoHS Compliance Marking For Medical Devices
While the previous version of RoHS directive did not require any special mark to demonstrate RoHS compliance, under the recast, it became mandatory that all equipment covered by RoHS must now bear the CE mark. As a symbol, CE mark is familiar for everyone as it has been a mandatory requirement for many years on products sold in the European Union. After the recast of the RoHS directive, it has also become the proof of conformity of the product to the European RoHS directive. The mark must be displayed on the product visibly, legibly and indelibly. Manufacturers, importers and distributors are responsible for ensuring that the mark is properly placed on EEE. The CE marking indicates a product’s compliance with EU legislation. By affixing the CE marking to a product, a manufacturer declares his sole responsibility, that the product meets all the legal requirements, which means that the product can be sold across the European Economic Area. RoHS 2 brings about a few other significant changes related to the broader scope of the directive which has implications on the legal responsibilities of businesses. Some of these changes affect manufacturers directly, as they are required to: Issue a signed Declaration of Conformity (DoC). Create a technical documentation file as per EN 50581:2012 or equivalent standards that meet requirements of module A of Annex II to decision 768/2008/EC. Accept analytical material test results as per the IEC 62321 Standard. Keep the DoC and technical documentation file for a longer period after the product has been placed in the market. Obtain the CE marking, to prove RoHS 2 compliance. Obligations for medical device manufacturers Now, since the medical devices also fall within the scope of RoHS2 directive (2011/65/EU), Medical Device manufacturers are obligated to ensure and demonstrate compliance with the directive. If a medical device is properly CE marked and has the necessary documentation for verification, it does not require additional approval or certification to be marketed in the European Union (EU), European Economic Area (EEA), or Switzerland. RoHS compliance for medical devices ensures that the product meets environmental standards, and with CE marking, it allows for the free movement of goods across these regions. The CE mark is a legal designation that the manufacturer’s product has met the requirements of all relevant Medical Device Directives as laid down by EU (93/42/EEC or 90/385/EEC or 98/79/EC). In order to demonstrate compliance with the RoHS 2 recast, Medical Device Manufacturers are required to Define their product and identify the directives applicable to it. Source RoHS compliant material from suppliers, analyze and identify material changes needed to comply with the RoHS 2 directive. Show proof of RoHS 2 compliance by drawing up required technical documentation surrounding their product including conformity risk assessment reports, test reports for each part. Draw up an EC declaration of Conformity Affix the ‘CE’ mark on the finished product and start to sell. CE Marking is now a mandate for RoHS 2, manufacturers must draw up the required technical documentation, carry out an internal production control procedure, draw up an EC declaration of conformity and affix the ‘CE’ mark to their product. It is the manufacturer’s responsibility to carry out the conformity assessment, to set up the technical file, to issue the declaration of conformity and to affix the CE marking to a product. Distributors must check that the product bears the CE marking and that the requisite supporting documentation is in order. If the product is being imported from outside the EEA, the importer has to verify that the manufacturer has undertaken the necessary steps and that the documentation is available upon request. According to the other Medical Device Directives in the EU, subject to the type of the device, manufacturers require to have their quality systems and technical documentation reviewed by a Notified Body before they can place their products on the market as part of the conformity assessment procedure. However, RoHS 2 outlines surveillance responsibilities of member states but does not contain a mandate for Notified Body assessment of compliance with the RoHS 2 provisions. Only products which are designated as high risk to public interest require conformity assessment by a Notified Body. Unless there are grounds for suspecting that a device may pose a risk to public health, member states must not create any obstacles to the placing on the market or the putting into service of any medical devices as defined under the Directive bearing a legitimate CE marking. Since most of the CE standards that apply to products are harmonized, entry of the product into EU market only requires conformance to a single set of standards, this simplifies the process of entering the EU market for medical device manufacturers and also demonstrates the importance of obtaining the ‘CE’ mark.
What is RoHS All About?
RoHS Compliance, or more accurately EU Directive 2002/95 covering the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008 (the “RoHS Regulations”) is hard enough to pronounce (people tend to spell it out or opt for Ross, Roz or even sometimes, Rose) let alone to understand, so we thought we would try and sum up why it exists and why you should take notice of it in a couple of short paragraphs. Basically, what happens with EU directives is that they are passed for Europe as a whole and each member state has to implement the directive within its own laws. This law went live in July 2006 and anything made after this time must follow these environmental compliance laws. The topics covered in this directive are quite wide-ranging, for example, six hazardous substances have to be removed from all electrical and electronic equipment. These are Cadmium (Cd), hexavalent Chromium (CR VI), Lead (Pb), Mercury (Hg), polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). The directives also enforce recycling and safe disposal of old equipment that you have sold, these take-back schemes enforcing a duty of care upon the manufacturer and sometimes the distributor to either dispose of the item or to re-use parts. In Europe this comes under the WEEE Compliance Scheme which we cover elsewhere. Many other countries (such as the US, and China) are implementing their own version of RoHS and WEEE ,so even if you manufacture and ship outside the EU it would be well to at least learn the guidelines and stick with them as much as possible not only for the sake of the environment but also for your future ability to market products just about anywhere in the world.