行业信息
最新医疗器械和欧盟重要动态和法规更新
The 58% line: five takeaways the EU sweep
35 platforms, nearly 1,700 products, 560 corrective orders. What was checked was the listing page, not the product. Medical devices are outside the GPSR — but every one of the four checks has an MDR erpart.
Different rules, same exam.
A listing that fails a GPSR sweep would fail under the MDR as well.
PPWR three months in: substances are being checked now, 2030 is the real hurdle
reating the 2030 empty-space and recyclability rules as today''s red line wastes effort — but watching only 2026 will leave you short in 2029
The Packaging and Packaging Waste Regulation, Regulation (EU) 2025/40, entered into force on 11 February 2025 and applies generally 12 August 2026, when Directive 94/62/EC was repealed after nearly thirty years. It is not a single cut-off: 2026 tests substances and identity, 2030 tests design and waste.
EU MDR Revision: Ten Changes Coming — But the 28 November EUDAMED Deadline Won''''t Move
The revision lands at the earliest in 2027； the legacy-device registration deadline is two weeks away — no current date changes.
Two things are happening at once. On 28 November 2026, the EUDAMED registration window for legacy devices closes — after that, the question is no longer "when to register" but "how to remediate". In parallel, the MDR/IVDR revision proposal COM(2025)1023 is easing compliance burdens — but it will not apply before 2027. Urgent first, relief later.
EU UDI 服各台 信息汇总
唯一设备标识符 欧盟委员会
Regulation (EU) 2017/745 on medical devicesEN••• and Regulation (EU) 2017/746 on in vitro diagnostic medical devicesEN••• introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.
2023.03.15欧盟理事会法规(EU)2017/745 MDR修正案 2023/607 以及关于MDD的CE证书延期的FAQ
过渡期延长 MDR修正案 CE证书延期的FAQ
与公告机构签订MDR书面审核合同，并且须在规定时间前签订（旧证书有效期内最迟于2024年9月26日前）才能适用延长的过渡期。2023/607 以及关于MDD的CE证书延期的FAQ
欧洲议会正式通过进一步延长 MDR 过渡期
延长 MDR 过渡期
欧洲时间2023年1月6日，欧盟委员会发布了2023/0005(COD)提案，关于修订法规(EU)2017/745和(EU)2017/746的过渡期规定。2023年2月16日，欧洲议会对欧盟委员会提出的过渡期提案发起投票表决，并以537票正式通过。最终的修正案将会公布在欧盟官方公报(OJ)上
各国医疗器械管理及法规概况
食品药品管理局 医疗器械指令93/42/EEC
伴随着全球医疗需求的不断攀升，整体市场规模持续扩大。国内外医疗器械企业在不断拓展业务边界、丰富产品结构的同时，必须严格遵守相关法律法规，保障使用者的生命健康。
Packaging compliance needs two different representatives: one for the whole EU, one for every member state you sell into
Packaging compliance needs two different representatives: one for the whole EU, one for every member state you sell into
Regulation (EU) 2025/40 on packaging and packaging waste has applied directly in all 27 member states since 12 August 2026, replacing Directive 94/62/EC. There is no blanket exemption for medical device packaging — only the sterile barrier system receives conditional relief on two sustainability metrics. The mistake Chinese exporters make most often is not a failed test report: it is treating an existing MDR authorised representative as the PPWR representative.
欧盟医疗器械招标/并购信息1
欧盟医疗器械招标/并购信息1
新的医疗器械法规MDR包含了一般医疗器械MDD指令所涵盖的医疗器械以及AIMDD涵盖的所有产品，该法规的目的是确保更好地保护公众健康和患者安全。
欧盟医疗器械招标/并购信息2
欧盟医疗器械招标/并购信息2
伴随着全球医疗需求的不断攀升，整体市场规模持续扩大。国内外医疗器械企业在不断拓展业务边界、丰富产品结构的同时，必须严格遵守相关法律法规，保障使用者的生命健康。
欧盟医疗器械MDR法规简介
MDR AIMDD 医疗器械指令
新的医疗器械法规MDR包含了一般医疗器械MDD指令所涵盖的医疗器械以及AIMDD涵盖的所有产品，该法规的目的是确保更好地保护公众健康和患者安全。
