<?xml version="1.0" encoding="UTF-8"?><rss xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:atom="http://www.w3.org/2005/Atom" version="2.0"><channel><title><![CDATA[AF PHARMA SERVICE]]></title><description><![CDATA[EU and UK medical device, machinery and health products submissions.
EU Authorized Representative & UKRP
Templates approved by Notified Bodies!]]></description><link>https://www.afpharmaservice.com/medical-device-regulations-blog</link><generator>RSS for Node</generator><lastBuildDate>Sun, 31 May 2026 23:41:18 GMT</lastBuildDate><atom:link href="https://www.afpharmaservice.com/es/blog-feed.xml" rel="self" type="application/rss+xml"/><item><title><![CDATA[The Essential Guide to the Role of the UK Responsible Person (UKRP) for Foreign Medical Device Manufacturers]]></title><description><![CDATA[Entering the UK medical device market requires more than just a quality product. For foreign medical device manufacturers, understanding and complying with UK regulations is critical. One key requirement under the UK Medical Devices Regulations 2002, as amended, is the appointment of a UK Responsible Person (UKRP). This role acts as the manufacturer’s representative in Great Britain, ensuring smooth regulatory communication and compliance with UK authorities, primarily the MHRA (Medicines and...]]></description><link>https://www.afpharmaservice.com/post/role-of-the-ukrp-for-foreign-manufacturer</link><guid isPermaLink="false">6a1c71057ab417a19fbe3150</guid><pubDate>Sun, 31 May 2026 17:34:18 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/58a863_fdc51af8093a492c9fb1216a2f45423c~mv2.png/v1/fit/w_1000,h_768,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>pharmaserviceinc</dc:creator></item><item><title><![CDATA[Coordination for Health Technology Assessments of Medical Devices]]></title><description><![CDATA[A New Milestone in European Health Technology Assessment (HTA) On 17 October 2025, the European Commission adopted Implementing Regulation (EU) 2025/2086, establishing detailed procedural rules for conducting joint clinical assessments (JCAs)  of medical devices and in vitro diagnostic medical devices (IVDs) at Union level. This long-awaited implementing act builds on the framework of Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) and aligns it with the Medical Device...]]></description><link>https://www.afpharmaservice.com/post/coordination-for-health-technology-assessments-of-medical-devices</link><guid isPermaLink="false">69077ef7bd8621f464c6c6b5</guid><pubDate>Sun, 30 Nov 2025 17:53:27 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/ea997dc9475841f2a7709e8098764f30.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>pharmaserviceinc</dc:creator></item><item><title><![CDATA[Strategies for Cost-Effective Market Entry]]></title><description><![CDATA[Market Entry  doesn’t have to be slow or costly. Smart regulatory planning helps startups and manufacturers accelerate access to the EU, UK, US, and beyond transforming compliance from a burden into a strategic advantage. The Global Regulatory Maze - Market entry Expanding into international markets is a defining milestone for every manufacturer—but it can also be one of the most daunting. Divergent frameworks such as EU MDR/IVDR, UKCA, FDA, TGA, and Health Canada regulations create a...]]></description><link>https://www.afpharmaservice.com/post/strategies-for-cost-effective-market-entry</link><guid isPermaLink="false">69077928f82473eab6740d81</guid><pubDate>Sun, 16 Nov 2025 17:33:04 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_b0df5d06c30e47a0a1afd4a79aa8c1ac~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>pharmaserviceinc</dc:creator></item><item><title><![CDATA[Clinical Decision Support Software in Australia]]></title><description><![CDATA[Clinical Decision Support Software in Australia: When Is It a Medical Device? Introduction As digital health technologies evolve, the boundaries between health apps and medical devices have become increasingly complex. To provide clarity, the Therapeutic Goods Administration (TGA) released updated guidance in October 2025 titled “Understanding Clinical Decision Support Software (CDSS)” , outlining how clinical decision support systems are regulated under the Therapeutic Goods Act 1989 and...]]></description><link>https://www.afpharmaservice.com/post/clinical-decision-support-software-in-australia</link><guid isPermaLink="false">69078089064f940c71400ff4</guid><pubDate>Sun, 09 Nov 2025 17:59:05 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/58a863_318724ac932344c0b21355241e880814~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>pharmaserviceinc</dc:creator></item><item><title><![CDATA[Emerging Technologies Under MDR Rule 21 ]]></title><description><![CDATA[The EU MDR Rule 21 reshapes how substance-based and bioengineered medical devices are classified and approved. Learn how innovators in biomaterials, nanotech, and regenerative medicine can navigate compliance to bring disruptive therapies to market. The Changing Landscape of Medical Device Regulation The introduction of Rule 21 under the EU Medical Device Regulation (MDR 2017/745) has redefined how Europe regulates a new generation of medical devices, particularly those composed of substances...]]></description><link>https://www.afpharmaservice.com/post/rule-21</link><guid isPermaLink="false">69077657f82473eab674073f</guid><pubDate>Sun, 02 Nov 2025 15:27:06 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/78d045_a64e60c3c633483d9889b95b1b0dc607~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>pharmaserviceinc</dc:creator></item><item><title><![CDATA[UDI-DI Timelines Contact Lenses and Spectacles]]></title><description><![CDATA[MDCG 2025-7 outlines deadlines for implementing Master UDI-DIs for contact lenses, spectacle frames, and reading spectacles. Ensure MDR compliance with AF Pharma as your EU Authorized Representative.]]></description><link>https://www.afpharmaservice.com/post/udi-di-timelines-contact-lenses-and-spectacles</link><guid isPermaLink="false">68700bf727eef2b833a82672</guid><pubDate>Wed, 20 Aug 2025 21:18:06 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_42acf65ce2ac49fd960e34d993edd485~mv2.jpeg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Maria</dc:creator></item><item><title><![CDATA[UK IVD Alignment]]></title><description><![CDATA[The UK will align Class D IVD regulations with EU Common Specifications, replacing CTDA and easing market access. AF Pharma offers expert UKRP services to support manufacturers entering the GB market. Learn more at www.afpharmaservice.com.]]></description><link>https://www.afpharmaservice.com/post/uk-ivd-alignment</link><guid isPermaLink="false">687008eec526fa5802ffa7f7</guid><pubDate>Wed, 06 Aug 2025 20:36:07 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_7c02925a92d2463b9cddb729793db09d~mv2.jpeg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Maria</dc:creator></item><item><title><![CDATA[FDA QSub 2025]]></title><description><![CDATA[Explore the latest FDA Q-Sub guidance (2025) updates and learn how AF Pharma can support your FDA submissions as your U.S. Agent for medical devices.]]></description><link>https://www.afpharmaservice.com/post/fda-qsub-2025</link><guid isPermaLink="false">686ed506c0e95558db2980ea</guid><pubDate>Wed, 23 Jul 2025 21:45:12 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/e0627b78d3174aa2919c16dcde462dfa.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Soledad</dc:creator></item><item><title><![CDATA[PMS Plan]]></title><description><![CDATA[Learn how to create an MDR-compliant PMS Plan, what it must include, and how it supports post-market safety, clinical evaluation, and risk management.]]></description><link>https://www.afpharmaservice.com/post/pms-plan</link><guid isPermaLink="false">686ad3f1313711f211f832a3</guid><pubDate>Sun, 06 Jul 2025 19:54:56 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_6f3b3752accf4cf08fb88b6606150b8e~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Maria</dc:creator></item><item><title><![CDATA[PSUR Template]]></title><description><![CDATA[Understand PSUR requirements under EU MDR: when it's needed, what to include, and how to maintain compliance through structured post-market reporting.]]></description><link>https://www.afpharmaservice.com/post/psur-template</link><guid isPermaLink="false">686ad2ca313711f211f82f96</guid><pubDate>Sun, 06 Jul 2025 19:48:51 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_475001018e4e42eaa6839d98a6cb7ac4~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Soledad</dc:creator></item><item><title><![CDATA[PMCF]]></title><description><![CDATA[Stay MDR compliant: Learn what PMCF is, when it's required, and how to implement it to ensure clinical safety and performance post-market.]]></description><link>https://www.afpharmaservice.com/post/_pmcf</link><guid isPermaLink="false">686ad11936d58b89f7b678d3</guid><pubDate>Sun, 06 Jul 2025 19:44:21 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_168c6920be2d4c129f50f3df02413247~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Maria</dc:creator></item><item><title><![CDATA[Article 4 of the EU AI Act]]></title><description><![CDATA[Understand the AI literacy obligations under Article 4 of the EU AI Act and what providers and deployers must do to comply, including training, risk analysis, and documentation.]]></description><link>https://www.afpharmaservice.com/post/article-4-of-the-eu-ai-act</link><guid isPermaLink="false">682353f9345cfad741470e74</guid><pubDate>Thu, 29 May 2025 06:00:13 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/2b41a1572aa78ad445e75cef4a0f2fb7.jpg/v1/fit/w_350,h_220,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Soledad</dc:creator></item><item><title><![CDATA[ISO 13485 vs ISO 9001]]></title><description><![CDATA[Learn the key differences between ISO 13485 and ISO 9001 and why ISO 13485 is essential for medical device manufacturers aiming for regulatory compliance.]]></description><link>https://www.afpharmaservice.com/post/iso-13485-vs-iso-9001</link><guid isPermaLink="false">6823526a492ff4fd56d269e3</guid><pubDate>Tue, 13 May 2025 14:11:44 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_14b1ebf48b494daf9f1c5a0db9f82c13~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Maria</dc:creator></item><item><title><![CDATA[Medical Devices Cosmetics Training]]></title><description><![CDATA[Request AF Pharma’s expert-led MedTech Regulatory Training to learn how to classify medical devices vs. cosmetics, understand mechanisms of action, and navigate global regulations across the EU, UK, US, and China.]]></description><link>https://www.afpharmaservice.com/post/medical-devices-vs-cosmetics-training</link><guid isPermaLink="false">67f93596cbbe0c39b8385412</guid><pubDate>Wed, 30 Apr 2025 17:29:05 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/782e82bd666b4f4f9e7ebb0d7c160b76.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Soledad</dc:creator></item><item><title><![CDATA[ MOCRA FDA]]></title><description><![CDATA[MOCRA is transforming cosmetic regulations in the US. Learn what your brand must do to comply with FDA requirements—and how AF Pharma can support you with Responsible Person services, product listings, safety substantiation, and more.]]></description><link>https://www.afpharmaservice.com/post/mocra-fda</link><guid isPermaLink="false">67f93455c9ecd4484136a828</guid><pubDate>Thu, 24 Apr 2025 07:00:15 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_3d29186e8c8346db9c7cd9577e360ac5~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Maria</dc:creator></item><item><title><![CDATA[Clinical Investigations UK]]></title><description><![CDATA[Understanding clinical investigations in the UK is essential for medical device manufacturers. This article outlines MHRA requirements and highlights how AF Pharma, as your UK Responsible Person (UKRP), ensures regulatory compliance and market success.]]></description><link>https://www.afpharmaservice.com/post/clinical-investigations-uk</link><guid isPermaLink="false">67f932e49a3949b1b4cbfec4</guid><pubDate>Sun, 20 Apr 2025 07:00:12 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/e43c87aafac9488d9121e9dfad0ba1af.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Maria</dc:creator></item><item><title><![CDATA[Borderline Manual]]></title><description><![CDATA[Borderline Manual for medical devices]]></description><link>https://www.afpharmaservice.com/post/borderline-manual</link><guid isPermaLink="false">67f828e706e8f42d47a3bf2f</guid><pubDate>Thu, 10 Apr 2025 20:28:31 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_e8165589a9884a5e93feb8813b52e0bc~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Maria</dc:creator></item><item><title><![CDATA[Digital Health in Germany]]></title><description><![CDATA[Germany’s digital health sector is booming, but navigating market access, regulatory compliance, and reimbursement pathways is challenging.]]></description><link>https://www.afpharmaservice.com/post/digital-health-in-germany</link><guid isPermaLink="false">67b610da86930376d44b5083</guid><category><![CDATA[Medical device]]></category><category><![CDATA[Regulation]]></category><category><![CDATA[Software]]></category><pubDate>Thu, 27 Mar 2025 11:00:36 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_2a70042d56cd4db1a2729944834ef6fa~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Soledad</dc:creator></item><item><title><![CDATA[Nanotechnology Based Medical Products]]></title><description><![CDATA[Nanotechnology is transforming medicine, but regulatory classification remains complex. ]]></description><link>https://www.afpharmaservice.com/post/nanotechnology-based-medical-products</link><guid isPermaLink="false">67b60be65b939fbe298b2af9</guid><pubDate>Thu, 20 Mar 2025 11:00:12 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_38628f29dc5f44169ab7a7895a4a1397~mv2.jpg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Soledad</dc:creator></item><item><title><![CDATA[Swissmedic PMS]]></title><description><![CDATA[wissmedic’s 2025 focus campaign reviewed 30 legacy medical devices from non-Swiss manufacturers, revealing widespread non-compliance in PMS ]]></description><link>https://www.afpharmaservice.com/post/swissmedic-pms</link><guid isPermaLink="false">67b609cb8073607eeca28958</guid><pubDate>Thu, 13 Mar 2025 11:00:16 GMT</pubDate><enclosure url="https://static.wixstatic.com/media/11062b_a47a074c81b1477ca9ca03a8467d1b10~mv2.jpeg/v1/fit/w_1000,h_1000,al_c,q_80/file.png" length="0" type="image/png"/><dc:creator>Soledad</dc:creator></item></channel></rss>