欧盟医疗器械行业最新动态
欧盟医疗器械行业最新动态
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(EU) 2025/40, entered into force on 11 February 2025 and applies generally 12 August 2026, when Directive 94/62/EC was repealed after nearly thirty years.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.
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
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.
