Amending Regulation (EC) No 1907/2006: A New Era for DEHP in Medical Devices
The European Union has recently made significant amendments to Regulation (EC) No 1907/2006, specifically concerning the use of bis(2-ethylhexyl) phthalate (DEHP) in medical devices. This change marks a pivotal moment in regulating chemical substances within the medical field. The Original Regulation: Regulation (EC) No 1907/2006, otherwise called REACH (Registration, Evaluation, Authorization and Restriction of Chemicals), was laid out by the European Parliament and the Gathering of the European Association. It is intended to guarantee an elevated degree of protection for human well-being and the climate from the dangers presented by chemical compounds. The Role of DEHP: DEHP is a phthalate, a set of chemical compounds frequently used to make plastics more adaptable. In the clinical field, DEHP is usually tracked down in medical gadgets, including intravenous tubing and blood sacks. Nonetheless, concerns have been raised about its potential endocrine-upsetting properties. The Amendment: The amendment to Regulation (EC) No 1907/2006, Commission Regulation (EU) 2021/2045, was informed under G/TBT/N/EU/7601. It explicitly addresses the utilization of DEHP in medical gadgets. Initially, the guideline set the Latest Application Date (LAD) for involving DEHP in Medical gadgets to November 27, 2023, and the Sunset Date (SD) to May 27, 2025. Be that as it may, the correction expands these dates, pushing the LAD to January 1, 2029, and the SD to July 1, 2030. Implications and Future Directions: This expansion provides makers with an extra opportunity to get rid of the utilization of DEHP in medical gadgets or to look for approval for its continued use. It likewise considers further investigation into the potential well-being impacts of DEHP and the improvement of more secure other options. The amendment of Regulation (EC) No 1907/2006 means the EU’s obligation to consistently reevaluate and refresh its guidelines to reflect current logical comprehension and to guarantee the highest level of well-being for its citizens. As we move forward, it will be crucial to monitor the impacts of this amendment on the medical device industry and public health. The extension of the LAD and SD for DEHP use in medical devices is a significant step, but it is just one part of the ongoing journey towards safer and more sustainable healthcare practices. In MDR, there are 22 grouping rules. MDCG gives further direction regarding every one of these standards. The coordination bunch portrays for each situation the sub-rules and the gambling classes they have a place with prior to making sense of the common guidelines. Carefully intrusive gadgets are expected for transient use. Explore the latest guidelines under the Medical Devices Regulation (MDR) and engage in a conversation with one of our experts to stay informed and ensure compliance with the evolving regulatory landscape. FAQs: 1.What is the amendment to Regulation (EC) No 1907/2006 about? The amendment pertains to the use of bis(2-ethylhexyl) phthalate (DEHP) in medical devices. 2. What is the Latest Application Date (LAD) and Sunset Date (SD) set by Commission Regulation (EU) 2021/2045? The LAD for uses of DEHP in medical devices is set until November 27, 2023, and the SD is until May 27, 2025. 3.What are the transitional provisions laid down in Regulations (EU) 2017/745 and (EU) 2017/746? These provisions state that medical devices with a valid certificate issued under certain Council Directives could be placed on the market until May 26, 2024, and continue to be made available on the market or put into service until May 26, 2025. 4.What is the transitional period for certain in vitro diagnostic medical devices? The transitional period has been extended until May 26, 2025 for high-risk in vitro diagnostics, until May 26, 2026 for medium-risk in vitro diagnostics, until May 26, 2027 for lower-risk in vitro diagnostics, and until May 26, 2028 for certain provisions concerning devices manufactured and used in health institutions. 5.What does the draft Commission Regulation propose? It proposes to extend the LAD for uses of DEHP in medical devices until January 1, 2029, and the SD until July 1, 2030.
Compliance Update Alert: MDR introduces 22 new rules to classify medical devices
A comprehensive guide to medical device classification EU was published on October 20, 2021 by The Medical Device Coordination Group (MDCG). MDCG guidelines are detailed in a 57-page document, detailing how medical devices are classified, and providing rules to help in this process. The document also discusses how the classification affects pre- and post-market regulatory requirements. The EU medical device legislation classifies medical devices according to their potential risks and the vulnerability of the human body. Using this classification system, medical devices are classified according to risk factors. A device is classified according to a set of criteria, such as how long it is in contact with the body, the extent of its invasiveness, local or systemic effects, potential toxicity, the region of the body it affects, and whether it is powered by another source of energy. These criteria are referred to as classification rules and are described in the MDR Regulation (EU) 2017/745. MDR requires that all devices comply with all relevant requirements, regardless of their categories or classes. According to MDR Article 51, medical devices are categorized into four classes based on their intended purpose and inherent risks – class I, IIa, IIb, and III. In their technical documents, manufacturers must include the risk class of their device, as well as the reasons for the classification. MDCG’s guidance is based on the MDR annex that the European Union has already provided classification rules in order to help manufacturers comply with the rules and understand the ramifications of their classification. A practical example is provided to illustrate how the terms duration of use and invasiveness are used to carry out classifications. Once the terms are explained and clarified, the guidance explains the application of the classification rules. An example of how to apply the classification rules according to MDCG is a simple wound drainage system consisting of a cannula, tubing, and collector unit. Tubing and collectors are non-invasive, so they are categorized under class I and are subject to rule 1. On the other hand, the cannula is surgically invasive, so it falls under rule 7 and is classified as class IIa. As a result, the manufacturer could apply class IIa to the whole device or carry out separate conformity assessment procedures for the class I and IIa components. In the guidance, it is acknowledged that, while the rules “adequately classify the vast majority of existing devices,” a “small number” of products might be more difficult to classify. If there is a disagreement between the manufacturer and the notified body about classification, the case may be referred to the competent authority in the country where the manufacturer is registered. In MDR, there are 22 classification rules. MDCG provides further guidance regarding each of these rules. The coordination group describes in each case the sub-rules and the risk classes they belong to before explaining the general rules. Surgically invasive devices intended for short-term use, for example, fall under rule 7. In other words, they are class IIa unless their purposes or features qualify them for class IIb or III. Do you want to learn more about the new rules under the Medical Devices Regulation, talk to one of the MDR specialists today!
Everything you need to know about In Vitro Diagnostic Regulation – (IVDR)
The “In Vitro Diagnostic Regulation” (IVDR) is a new regulation by the EU applicable for In Vitro Diagnostic (IVD) Medical Devices. The IVDR came into effect on May 25, 2017, with a five-year transition period for manufacturers and suppliers. The new regulation replaces the In Vitro Diagnostics Directive (IVDD) 98/79/EC. The new regulation is significant for IVD medical device manufacturers because it introduces a new rule-based classification system and increased notified body involvement. The new classification system will replace the currently practiced list-based approach. The manufacturers need to comply with the new requirements from May 26, 2022, to place their products in the EU market. The products already certified by the notified bodies have a period until May 25, 2024. The manufacturers of In Vitro Diagnostic Medical devices need to manage requirements as per the new update to get their products CE-Marked under the new regulation. The regulation allows more time for the transitions if required because of the increased number of devices in the market, reviews by notified bodies, and the ongoing need to interpret some regulatory provisions. The prominent changes introduced in the new IVDR (EU 2017/746) are: Reclassification of devices: Devices will be reclassified according to the risks, ranging from Lower risk; class A – Higher Risk- class D. More clinical evidence: Manufacturers need to conduct more clinical studies and provide safety and performance evidence, as per the risk category. Expanded product scope: This will cover diagnostic services (including internet -based), genetic testing and other tests that gives a patient’s information on specific disease or susceptibility. No Grandfathering Provisions: All the currently approved devices must be recertified as per the new regulatory requirements. Premarket approval approach for self-testing and near patient testing devices. Identification of “person responsible for regulatory compliance”. Documentation to become more stringent with Rigorous surveillance by Notified bodies. Implementation of Unique device identification is a must, for traceability. Post market surveillance requirement will be increased and general timeline for reporting is reduced. Greater Scrutiny of Notified body The In Vitro Diagnostic Medical Device development is highly complex and makes their transition period even more complicated and time-consuming. We at ComplianceXL, Simplify Compliance by providing comprehensive solutions that cover consulting, compliance strategy, training, and documentation to ensure your medical devices comply with applicable regulations across the globe. Talk to one of our Medical Devices Regulation Specialists today!
EU Compliance Outlook 2021
Here is the snapshot of most important developments that we can expect in 2021, by European Union. EU Batteries Regulation A proposal for EU batteries laws were published on Dec 2020. This proposal will fully replace replacing the existing directive and mends all aspects of battery design, performance and end of life. It introduces over time innovative new supply chain diligence, labelling, carbon footprint and other new measures. Its due to take effect from 1 January 2022. New EU Regulation on Mobile phones and tablets Commission intent to introduce two new EU-wide regulations – an implementing measure under the Ecodesign Directive, and a delegated act under the Energy Labelling Regulation. This mainly targets on what commission identifies as unnecessary waste and alleged planned obsolescence. A public consultation to analyze waste management is planned for Q2 of 2021. EU Machinery directive A draft for replacing machinery directive with the EU new Machinery regulation is expected to be published in Q1 2021. RoHS directive evaluation A Commission report is expected on Q2 2021 REACH SVHC updation Second set of REACH SVHC candidate updated list is expected on Q3 2021. E-PRTR (EU Industrial Emissions Directive and European Pollutant Release and Transfer Register) E-PRTR is to be revised – Expecting a draft text of proposed revisions in Q4 2021. EU Shipment of Waste Regulation EU Shipment of waste regulation is about to revised. Its Q2 2021 plans are – The Commission is expecting to propose revision to reduce shipments of waste to outside the EU. Shipment waste procedures to reflect the objectives of the circular economy and improve enforcement EU Emissions Trading Scheme (EU ETS) Revision Consultation on current ongoing until early February 2021. A formal draft of amendment to EU ETS is expected in the first half of 2021. There are proposals to extend the EU ETS to new sectors such as maritime and enhance the regime to align with the EU’s 2050 carbon neutrality objectives. Action on methane emissions in the energy sector Currently, there are no EU-level legislation targeting methane emissions in the energy sector. Adoption of the draft text for a new Regulation proposal is planned for Q4 2021. The new for methane regulation under consideration involves possible binding rules on the monitoring, reporting and verification of methane emissions, as well as methane emission reduction measures to support the EU’s climate neutrality objectives. Health and Safety at Work EU Strategic Framework 2021-2027 The new framework aims in maintaining and improving health and safety standards, in the range of new challenges being faced by workplaces, like new ways of working, technological development and digitalisation and COVID-19. The ongoing public consultation will remain open until 1 March 2021. The new health and safety framework is expected to be finalised in Q2 2021. EU Regulations on Organic production and labelling its products The EU has strict monitoring on the of products that are certified and labelled as “organic” in 2021. The upcoming organic legislation is expected to be effective from 1 January 2022, postponed for a year as per EU Commission’s proposal. The new regulation is designed to ensure fair competition for farmers while maintaining consumer trust and preventing fraud. Medical Devices Regulation The Medical Devices Regulation will create a stronger, transparent, and sustainable regulatory framework, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals. Following the transition period, on 26 May 2021, the Medical Device Regulation will effective completely. The corresponding date for application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) still remains in May 2022. Companies involved in manufacturing and supply of products in various industries, need to look out for many more such updates and easily sail through without complications. Talk to one of our global compliance to learn more about how you can stay compliant with upcoming regulations and amendments in 2021.