How to Update Documents for EU Standards

Have you started your Declaration of Conformity process? The Declaration of Conformity (DoC) itself is a relatively simple document. It’s a statement of conformity with the PPWR requirements applicable at a given point in time. The real challenge lies in establishing and linking all the technical documentation needed to substantiate those statements, which is a new process for many companies. It also raises questions about which function is responsible for what, and who needs to sign the DoC on behalf of the company. Take it step by step. ➡️ Below is my proposed approach to those steps. 1️⃣ Establish ownership and governance - Appoint a DoC project lead to oversee implementation. - Define cross-functional roles and responsibilities based on PPWR requirements. - Align DoC governance with the corporate QMS structure to ensure consistency and auditability. 2️⃣ Map packaging portfolio - Identify all packaging types placed on the EU market - categorize by material, function, and product category. - Determine which packaging types require individual DoCs and which can be merged for efficiency. 3️⃣ Develop internal DoC template - Use the structure from Annex VIII and content from Annex VII. - Create standardized templates for different packaging types. - Build a centralized digital repository for DoCs and linked technical documentation, integrated with QMS document control systems. 4️⃣ Define data requirements and sources - List all required data points (e.g. recycled content %, PFAS test results, minimization rationale, etc). - Identify internal and external data sources: suppliers (technical specs, certifications), labs (test reports), packaging design and quality teams (drawings, performance specs), etc. - Ensure data traceability and version control through QMS procedures. 5️⃣ Engage suppliers - Communicate new technical documentation expectations and the process to collect them. - Set up a technical data collection and validation process for supplier inputs. 6️⃣ Integrate with packaging development and change management - Embed DoC preparation into packaging development workflows. - Ensure reassessment triggers are defined (e.g. material change, new standards). - Link DoC updates to specification change control systems. 7️⃣ Prepare for market surveillance - Implement internal audit procedures to verify DoC accuracy. - Ensure readiness to respond to authority requests within 10 days (e.g. a QR code linking to the complete dossier). - Track and report audits and compliance status. 8️⃣ Monitor regulatory updates - Assign responsibility for tracking delegated acts and harmonized standards. - Update templates and procedures as new requirements are adopted under PPWR 2026–2040. What's your biggest challenge in terms of DoC preparation? __________________ ✅ In my content, I provide guidance on EU PPWR through the lens of business sense. Follow me for practical advice.

EMA: Chapter 4 - new Requirements for GMP Documentation? The European Medicines Agency published a draft revision of Chapter 4 (Documentation) of the EU GMP Guideline on 7 July 2025, which introduces significant new requirements for GMP documentation. The draft, open for public comment until 7 October 2025, is set to replace the 2011 version. 1. Risk-Based Data Governance: The revised chapter integrates risk management throughout, requiring that document controls scale with the criticality and risk of the data involved incorporating ICH Q9 principles into all documentation controls. 2. Uniform Documentation Standards: Documentation obligations now explicitly extend to all formats (paper, digital, hybrid), ensuring requirements for accuracy, traceability, integrity apply regardless of medium. 3. Data Integrity and ALCOA++ Principles: The ALCOA++ framework ensuring data are Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available is embedded throughout. Controls such as contemporaneous recordkeeping and independent data checks are emphasized. 4. Electronic and Hybrid Systems: The new draft clarifies validation, management, and audit trail requirements for electronic and especially hybrid (paper + digital) documentation systems. Organizations must fully describe and validate these systems, with special attention to interfaces and transcriptions between manual and digital records. 5. Electronic Signatures: Hybrid systems that have both paper and electronic signatures must specify which is regulatory. The permanence and regulatory relevance of electronic signatures must be assured, and the entire process must be documented and traceable 6. Document Retention: The draft establishes clear retention periods for GMP documentation, including special requirements for clinical trial & Advanced therapy medicinal products (ATMPs) records. Controls must prevent unauthorized deletion and ensure consistent, secure document access over the required retention period. 7. Expanded Definitions: New and clarified terms for "raw data," "True Copy," "Certified Copy," and "Verified Copy" are provided. "Controlled Copy" is no longer listed, while the "Official Copy" is mentioned but not fully defined. 8. Emerging Technologies and AI: New requirements recognize and regulate the use of tools such as artificial intelligence and automated scripts, specifying that these must still meet GMP standards for traceability and integrity. 9. Increased Detail and Documentation Types: Descriptions and requirements for master document types used in production and quality control (including blank forms and test protocols) are now more detailed and prescriptive. 10. Archiving and Outsourcing: Special provisions address the increased outsourcing of GMP activities, including stipulations about service provider-controlled archives and responsibilities. #gmp #learning #gda #ema #healthcare #drug #quality #qa #pharma

2025 Draft Revision of EU GMP Chapter 4 – Documentation Consultation Period: Open from 7 July to 7 October 2025, in parallel with updates to Annex 11 (Computerised Systems) and the new Annex 22 (AI) . What’s New in Chapter 4? • Expanded Scope & Structure: Updated from 9 to 17 pages, with ~50% completely rewritten and the rest heavily revised. A new glossary has also been added . • Data Governance Takes Center Stage: Mandates a risk-based data governance system covering data integrity across the entire data lifecycle—creation, processing, tracing, archiving, and disposal—whether in paper, electronic, or hybrid formats . • ALCOA++ Codified: Formalizes principles like Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available, Traceable for both static and dynamic data . • Comprehensive Documentation Controls: • Reinforced expectations for master documents, such as validation master plans and site master files. • Detailed rules on signatures, including permanent, electronic, and hybrid systems. • Clear retention timelines—especially for raw data and validation records—with controlled disposal protocols . Why It Matters • Aligns with Industry 4.0: Ensures documentation standards evolve alongside digital transformation and hybrid systems. • Raises the Bar on Data Integrity: Makes full lifecycle traceability and accountability a regulatory expectation. • Boosts Compliance Clarity: Reduces ambiguity around hybrid documentation, signature governance, and record longevity. What You Can Do Now • Explore the public drafts and consider submitting feedback via the EU Survey tool before 7 Oct 2025 . • Begin aligning your SOPs, documentation workflows, and digital systems with the proposed updates—especially around data governance and ALCOA++. #EUGMP #DocumentControl #DataIntegrity #ALCOAplusplus #GMPUpdate

𝐈𝐟 𝐲𝐨𝐮 𝐰𝐨𝐫𝐤 𝐮𝐧𝐝𝐞𝐫 𝐌𝐃𝐑 𝐨𝐫 𝐈𝐕𝐃𝐑, 𝐮𝐩𝐝𝐚𝐭𝐞 𝐲𝐨𝐮𝐫 𝐬𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 𝐦𝐚𝐭𝐫𝐢𝐱. 𝐍𝐨𝐰. On January 28, 2026, the European Commission published two Implementing Decisions adding 18 harmonized standards. Both in a single day. That is a substantial expansion of the harmonized standards landscape, and it touches critical areas: implants, biocompatibility, sterilization, clinical investigations, IVD labeling, and respiratory components. For those less familiar with the mechanism, applying a harmonized standard grants manufacturers a presumption of conformity with the relevant regulatory requirements. Technically voluntary. Practically essential. Notified Bodies expect it, and deviating means you carry the full burden of justification yourself. 𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗶𝘀 𝗰𝗵𝗮𝗻𝗴𝗲 𝗶𝗻 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲? Clearer expectations for technical documentation. Stronger alignment during conformity assessment. And considerably fewer debates with auditors about methodology. 𝗠𝗗𝗥 - 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗶𝗻𝗴 𝗗𝗲𝗰𝗶𝘀𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟮𝟲/𝟭𝟵𝟯 - 12 harmonized standards were added, covering areas such as: Non-active surgical implants Neurosurgical implants Clinical investigations (GCP)-EN ISO 14155:2020/A11:2024 Sterilization (moist heat)-EN ISO 17665:2024 Biocompatibility and breathing gas pathways 𝗜𝗩𝗗𝗥 - 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗶𝗻𝗴 𝗗𝗲𝗰𝗶𝘀𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟮𝟲/𝟭𝟵𝟳 -6 new standards added - and this one deserves attention. The complete EN ISO 18113 series (Parts 1-5) is now harmonized, providing a full labeling framework for IVDs across professional use and self-testing categories. A significant gap, finally addressed. Plus, the same moist heat sterilization standard as MDR. 𝗜𝗳 𝘆𝗼𝘂𝗿 𝘁𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗳𝗶𝗹𝗲𝘀 𝘀𝘁𝗶𝗹𝗹 𝗿𝗲𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗼𝘂𝘁𝗱𝗮𝘁𝗲𝗱 𝗲𝗱𝗶𝘁𝗶𝗼𝗻𝘀, 𝗹𝗲𝗴𝗮𝗰𝘆 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀, 𝗼𝗿 𝗿𝗲𝗹𝘆 𝗼𝗻 𝗶𝗻𝘁𝗲𝗿𝗻𝗮𝗹 𝗶𝗻𝘁𝗲𝗿𝗽𝗿𝗲𝘁𝗮𝘁𝗶𝗼𝗻𝘀 𝘄𝗵𝗲𝗿𝗲 𝗮 𝗵𝗮𝗿𝗺𝗼𝗻𝗶𝘇𝗲𝗱 𝗽𝗮𝘁𝗵 𝗻𝗼𝘄 𝗲𝘅𝗶𝘀𝘁𝘀, 𝗿𝗲𝗮𝘀𝘀𝗲𝘀𝘀 𝗻𝗼𝘄. Both decisions took effect immediately on January 30, 2026 Manufacturers should review whether these newly harmonized standards are relevant to their products and assess the impact on: ➡️ GSPR checklists ➡️ Technical documentation ➡️ Labeling and IFU strategies ➡️ Ongoing and future conformity assessments 𝗔𝘀 𝗮𝗹𝘄𝗮𝘆𝘀, 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝘀𝗵𝗼𝘂𝗹𝗱 𝗯𝗲 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗲𝗱 𝗯𝗮𝘀𝗲𝗱 𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝘀𝗰𝗼𝗽𝗲, 𝗿𝗶𝘀𝗸 𝗰𝗹𝗮𝘀𝘀, 𝗮𝗻𝗱 𝗶𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝘂𝘀𝗲 – 𝗻𝗼𝘁 𝗮𝗱𝗼𝗽𝘁𝗲𝗱 𝗮𝘂𝘁𝗼𝗺𝗮𝘁𝗶𝗰𝗮𝗹𝗹𝘆. Do not wait for your Notified Body to flag it. Get ahead of it. 🔗 MDR Link https://lnkd.in/d6buCBbc 🔗 IVDR Link https://lnkd.in/dpzvDYA2 Gsap Mor Moshe Iris Shamir Dr. Sivan Luder Avital Levertov #MDR #IVDR #HarmonizedStandards #MedicalDevices #RegulatoryAffairs #EURegulation #MedTech

🇪🇺 New harmonised standards under MDR The Commission has just published on 20 Oct 2025 a new Implementing Decision (EU) 2025/2078, updating the list of harmonised standards under the MDR. These new references are now officially listed in the OJEU and provide presumption of conformity with the applicable MDR requirements: • EN 13795-1:2025 – Surgical gowns and drapes – Part 1 • EN 13795-2:2025 – Surgical clothing – Part 2 • EN 14683:2025 – Medical face masks • EN 14180:2025 – Medical sterilizers (steam/formaldehyde at low temp) These 2025 versions replace older editions. If your technical documentation or quality procedures still reference the 2019 or 2014 versions: it’s time to review. Why does it matter? • Because conformity with these harmonised standards offers a safe regulatory shortcut under Article 8(1) MDR. • Because Notified Bodies will now expect these versions as your new baseline. • Because the transition will not be automatic: if you claim conformity, you must implement the new requirements. Want to stay compliant, without drowning in details? At CSDmed, we help device manufacturers keep their documentation up to date and compliant, efficiently. 🔗 𝐋𝐢𝐧𝐤 𝐢𝐧 𝐭𝐡𝐞 𝐜𝐨𝐦𝐦𝐞𝐧𝐭𝐬 💕 𝐄𝐧𝐣𝐨𝐲 ———————————— 𝐂𝐒𝐃𝐦𝐞𝐝 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐢𝐧𝐠 𝘢𝘴𝘴𝘪𝘴𝘵𝘴 𝘪𝘯 𝐑&𝐃, 𝐐𝐮𝐚𝐥𝐢𝐭𝐲, 𝐚𝐧𝐝 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝘤𝘩𝘢𝘭𝘭𝘦𝘯𝘨𝘦𝘴 𝘸𝘪𝘵𝘩 𝘢 𝘧𝘰𝘤𝘶𝘴 𝘰𝘯 𝐢𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐚𝐧𝐝 𝐩𝐚𝐭𝐢𝐞𝐧𝐭-𝐜𝐞𝐧𝐭𝐫𝐢𝐜 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬. 𝘞𝘩𝘢𝘵 𝘴𝘦𝘵𝘴 𝘶𝘴 𝘢𝘱𝘢𝘳𝘵? 𝘈 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐯𝐞 𝐬𝐩𝐢𝐫𝐢𝐭, 𝘧𝘰𝘤𝘶𝘴𝘦𝘥 𝘰𝘯 𝐝𝐞𝐥𝐢𝐯𝐞𝐫𝐢𝐧𝐠 𝐢𝐦𝐩𝐚𝐜𝐭𝐟𝐮𝐥 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝘸𝘪𝘵𝘩 𝘢 𝐩𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐨𝐮𝐭𝐥𝐨𝐨𝐤. 𝘊𝘰𝘯𝘵𝘢𝘤𝘵 𝘶𝘴 𝘵𝘰 𝘥𝘪𝘴𝘤𝘰𝘷𝘦𝘳 𝘰𝘶𝘳 𝘢𝘱𝘱𝘳𝘰𝘢𝘤𝘩 𝘢𝘯𝘥 𝘷𝘢𝘭𝘶𝘦𝘴.