Medical device regulation in 2026: what's changing for silicone component suppliers

The regulatory landscape for medical devices has continued to evolve through 2025 and into 2026. For manufacturers of silicone components and assemblies, three areas are driving the most change in customer specifications: the extended EU MDR transition, the UK's divergent framework and tightening expectations around ISO 10993 biological evaluation.

None of these developments are new in isolation. What has changed is the way they now interact. A single silicone valve destined for both a CE-marked and a UKCA-marked device family may now be required to satisfy two parallel technical files, with different market-surveillance obligations, and biocompatibility evidence robust enough to withstand Notified Body challenge to historical read-across data. Referring to a supplier's ISO 10993 letter is no longer sufficient in isolation.

1. EU MDR — the extended transition is real, but the work is not deferred

Regulation (EU) 2023/607 extended the EU MDR transitional deadlines to 31 December 2027 for higher-risk legacy devices and to 31 December 2028 for lower-risk classes, subject to conditions including formal application to a Notified Body and appropriate quality-management-system arrangements being in place. In practice, the extension has not reduced customer activity — it has brought supplier engagement forward in the programme timeline.

Notified Bodies are processing a substantial queue of legacy devices, and manufacturers now require supplier-side technical evidence earlier in the file to secure review slots. Supplier documentation requests that previously arrived during the file-compilation stage now routinely arrive at the design-input stage, in some instances before the device manufacturer has finalised the risk classification.

For silicone component suppliers, that translates into more detailed and earlier requests for:

• Material lot traceability down to raw-material batch numbers, not just supplier certificates.
• Extractables and leachables data or, at minimum, a defensible position on why bridging to supplier data is appropriate for the specific application.
• Process validation summaries with statistical justification, not just IQ/OQ/PQ signatures.
• Change-control history covering material changes, tool changes, press changes and cleanroom modifications over the life of the part.
• Supplier quality agreements that name specific communication routes for change notification and CAPA sharing.

2. UK medical device regulation — divergence is now visible

The MHRA's post-implementation framework for the Medical Devices Regulations 2002 (as amended) continues to bed in. The Post-Market Surveillance regulations that came into force in June 2025 are now producing their first cycle of PSUR-style reports for UK-marketed devices, and further core-regulation changes are progressing through 2026 to establish a fuller UKCA framework.

Three practical implications for silicone component supply:

• Parallel documentation packs. Manufacturers supplying both EU and GB markets increasingly ask suppliers for documentation aligned to both regimes rather than a single EU-shaped file with a UK cover sheet.
• UK Responsible Person requirements. Overseas manufacturers routing product into GB through a UKRP are pulling their UK supply chain into that structure, with clearer contractual expectations on traceability and reportable-event flow.
• Acceptance windows for CE-marked devices. The GB acceptance of CE-marked devices continues, but the roadmap toward UKCA is now firm enough that customers no longer treat UKCA readiness as optional — even where the deadline is still comfortably ahead.

3. ISO 10993 and USP Class VI — familiar standards, higher expectations

ISO 10993-1:2018 remains the anchor standard for biological evaluation, but Notified Body reviewers are applying greater scrutiny across the family:

• ISO 10993-18 — chemical characterisation, with specific expectations regarding analytical method sensitivity and the manner in which extractables data is bridged into the specific device use case.
• ISO 10993-17 — toxicological risk assessment, with reviewers requiring clearer derivation of tolerable exposure limits and the qualifications of the toxicologist signing the assessment.
• Read-across from historical data — increasingly challenged where the "similar device" is clearly similar to the sponsor's previous product but not obviously similar to a reviewer approaching it without prior context.

Implant-grade silicones intended for greater than 29-day contact typically retain ISO 10993 and USP Class VI support from the raw material supplier (NuSil, Wacker, Shin-Etsu, Momentive). That supplier evidence remains necessary but is no longer sufficient. Responsibility for documenting the finished part, in its packaged and sterilised state, sits with the device manufacturer and, by extension, with the component supply chain.

What CPT is doing in response

• Expanded material traceability from incoming goods through to packaged finished product, with lot-level reconciliation in both directions.
• Structured technical dossiers per part family, formatted so that customer regulatory teams can incorporate sections directly into their own technical file.
• Early engagement on design for manufacture and material selection to reduce biocompatibility risk. An inappropriate pigment or additive selected at design freeze can necessitate a full rerun of the ISO 10993 programme.
• Continued alignment of the ISO 13485:2016 QMS with MDR and UK MDR supplier expectations, including change-notification arrangements that explicitly reference Notified Body implications.
• Regular internal review of raw-material supplier master files, so that available upstream evidence is understood in advance of a customer request.

Practical advice

Where an MDR remediation, a UKCA route or an ISO 10993 gap assessment on an existing silicone component is in progress, component-supplier engagement is best initiated earlier in the programme rather than later. The most significant cost savings tend to arise at the specification stage, well before design freeze. A material substitution that would require six weeks of tool trials and a fresh biocompatibility programme in production is often a short conversation before the tool is cut.

CPT's engineering and quality teams are available to support these discussions, whether in connection with a new programme, a legacy remediation or a second-source qualification. Enquiries can be made via the contact page.