Latest Insights on CE Certification and Environmental Regulations for Medical Products in 2024-2025: How Importers Can Navigate Regulatory Challenges

As the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) enter key enforcement stages, regulatory scrutiny on CE certification continues to intensify. Below are essential updates importers must understand:

1.IVDR Transition Period Extended to 2027–2029

To ease market pressure, Regulation (EU) 2024/1860 permits certain in vitro diagnostic devices to remain on the market under the old directive (IVDD) until between 2027 and 2029 depending on product category.

✅Recommendation:Verify whether suppliers have contracts with notified bodies and valid extension qualifications. Prioritize products still covered by the transition period.

2.Full Launch of the EUDAMED Database

The EUDAMED database will gradually become the sole regulatory platform for product data, including UDI, economic operators, certificates, clinical data, etc., with full mandatory implementation expected by 2025.

✅ Recommendation: Request suppliers provide SRN registration numbers and related EUDAMED information to facilitate cross-border sales, customs clearance, and after-sales support.

3.Dynamic Updates of Technical Documentation

Manufacturers must promptly update technical files and submit changes to notified bodies for any alterations in design, materials, labeling, or performance.

✅ Recommendation: Importers should regularly obtain the latest versions of Instructions for Use (IFU), Declarations of Conformity (DoC), and change records to ensure products are up-to-date with audits.

4.Major Changes Must Be Reported to EU Authorized Representatives and Notified Bodies

Changes such as material or process modifications must be notified to relevant regulatory authorities in advance, or sales may be deemed illegal.

✅ Recommendation: Establish internal monitoring mechanisms and request compliance reports for every change from suppliers to mitigate market access risks.

5.Increased Surveillance Frequency for High-Risk Products

Notified bodies like TÜV and DEKRA will conduct comprehensive annual reviews on high-risk devices (e.g., ECG monitors, glucose monitoring devices).

✅ Recommendation: Request annual audit reports or third-party GMP inspection records from suppliers to ensure ongoing compliance.

6.UKCA Mark to Replace CE Mark in the UK Market

The UK will fully enforce the UKCA mark from July 1, 2025; CE marking will no longer be valid.

✅ Recommendation: UK market importers must procure products bearing the UKCA mark and verify suppliers’ UK Responsible Person (UKRP) registration and UKCA certification status in advance.

Environmental Regulation Updates: Green Compliance as a New Threshold

Against the backdrop of Europe’s green transition strategy, household medical devices will face stricter environmental regulations. Key updates affecting export compliance include:

1.RoHS Directive Update

Extensions for exemptions on lead and cadmium in PVC have been granted, but material safety requirements continue to tighten.

✅ Recommendation: Suppliers should update RoHS test reports and ensure devices are free of newly restricted substances, especially in recycled material housings.

2.REACH Restriction on PFHxA Added

Perfluorohexanoic acid (PFHxA), widely used for oil and water repellency treatments, is now restricted; violations may result in severe environmental penalties.

✅ Recommendation: Request raw material Safety Data Sheets (SDS) and REACH compliance declarations, and prefer fluorine-free eco-friendly packaging and contact materials.

3.ESPR Ecodesign Regulation Passed

The Ecodesign for Sustainable Products Regulation (ESPR) will require all marketable products to feature low carbon footprints, reparability, and recyclability.

✅ Recommendation: Prioritize purchasing products with green labels and reusable structures (e.g., detection pens with replaceable cores).

4.Packaging and Packaging Waste Regulation (PPWR) Upgraded

From 2030, all EU packaging must be “technically recyclable” with minimal composite materials.

✅ Recommendation: Guide suppliers to adopt single-material packaging (such as PET boxes or paper trays) and leverage “eco-friendly packaging” as a marketing highlight.

International Alignment and Transition Policies

1.UKCA

Following Brexit, the UKCA mark replaces CE marking, with mandatory enforcement from July 1, 2024. The UK government permits many devices certified under CE to continue sales during transition periods: general medical devices (MDD/AIMDD) until June 30, 2028 (or certificate expiry); IVDs (IVDD) until June 30, 2030; MDR/IVDR-compliant products also until June 30, 2030. As of May 2024, the UK is exploring partial recognition of registrations/certifications from the EU, US, Australia, and Canada (under planning).

✅ Recommendation: Companies should complete UKCA registrations: appoint UK Responsible Persons, submit technical files, register labeling, and prepare for notified body certificates in the UK.

2.USA

The US FDA does not recognize the EU CE mark; medical devices must obtain FDA clearance or approval (510(k), PMA, etc.) to be marketed in the US.

✅ Recommendation: Companies targeting the US market should independently prepare submissions per FDA regulations. Note FDA accepts some international standards (e.g., ISO 13485) as part of compliance but requires full adherence to US laws.

3.Australia

Australia’s TGA adopts a phased alignment allowing partial use of CE certification for registration. By the end of 2024, TGA extended transition periods for IVDD devices registered with CE certificates until 2028-2030 by class. New rules permit Class 2/3 IVDs to use IVDD self-declarations in lieu of ISO 13485 certificates.

✅ Recommendation: Monitor TGA announcements and provide appropriate CE certificates or declarations during ARTG registration, complying with IVDR Article 110(3c).

The Company of Medasia

With 13 years of industry experience,Medasia stay up-to-date with the latest trends and regulations. For more detailed and comprehensive insights into the medical industry, feel free to reach out to us info@medasiagroup.com

References

[1] European Commission, Latest MDR/IVDR Amendments, 2024.

[5] UK MHRA, UKCA Mark Guidance, 2024.

[6] TÜV SÜD, MDR Surveillance Whitepaper, 2024.

[7] European Chemicals Agency (ECHA), REACH and RoHS Updates, 2024.

[8] European Environment Agency, RoHS Amendment, 2024.

[9] European Commission, ESPR Policy, 2024.

[10] EU Packaging Regulation (PPWR) Proposal, 2023.

[11] FDA, CE Mark Recognition Policy, 2024.

[12] Brazil ANVISA, Medical Device Regulatory Updates, 2024.

[13] ISO 13485 Medical Devices Quality Management System, 2016.

[14] SGS Group, Medical Device Market Compliance Whitepaper, 2024.