Medical Devices:
FDA Draft Guidance on Quality Management System Regulation (QMSR)
The FDA has published a Draft Guidance on the expectations regarding Quality Management System Regulation (QMSR) and the information that should be provided in marketing submissions, such as Premarket Approval and Humanitarian Device Exemption applications.
This new document is intended to replace the previous 2003 guidance considering the significant amendment to the medical device Current Good Manufacturing Practice requirements. The main regulatory change is the incorporation of the international standard ISO 13485:2016 into U.S. requirements, establishing the new QMSR (21 CFR part 820)
In summary, the draft guidance aims to support medical device manufacturers in preparing and maintaining the Quality Management System information required during premarket reviews. Once finalized, this guidance will clarify how to meet QMSR obligations in compliance with the updated regulatory framework.
Submissions and preapproval inspections that occur on and after February 2, 2026, will be subject to the new QMSR requirements.
Source: FDA
51 Notified Bodies Now Accredited as for October 2025
The number of Notified Bodies accredited under EU Medical Devices Regulation (EU) 2017/745 has reached 51 this month. This expands furtherly the capacity for conformity assessments within the European medical device regulatory system.
The result of this growing network is the support of certification processes on time creating greater accessibility for manufacturers across the EU market.
REACH:
New SME status verification procedure under REACH
On October 16, ECHA announced a change in the verification method for recognizing the status of SMEs and declared a 19.5% increase in the standard fees for large companies, reflecting inflationary standards.
While the update fees will take effect from November 5, 2025, the revised verification method will be enacted on February 5, 2027, giving the companies a 15-month transition period to prepare.
To improve the efficiency of the verification process, the updated procedures demand that the enterprise apply to ECHA for SME recognition at least two months before presenting REACH registration dossiers or applications.
To ease the burden of SMEs, once recognized, the SME status will remain valid for 3 years, with requested renewal 2 months before expiry.
This procedure is going to switch from a retroactive check to a mandatory upfront process, placing greater responsibility on SMEs to plan submissions in advance.
Source: ECHA
EUCLEF:
Updates to EU Chemicals Legislation Finder
EUCLEF is a regulatory information tool that enables companies, especially SMEs, to determine which legal obligations and regulations cover their chemical substances in the EU.
As for November 2025, it incorporates 51 European Legislations including different areas of chemical compliance regulation.
For each piece of legislation, you can find a summary of all the relevant information in the EUCLEF report, including the scope, obligations, exemptions, regulatory activities and lists of impacted substances
Some crucial areas covered include Chemicals Control Legislation (rules concerning the inland transport of dangerous goods, plant protection products, and pesticide residues), Environmental Legislation (Air, Industrial Emissions, Waste, and Water, Chemical Agents and Chemical Safety) and Food Safety and Food Contact Material Legislation.
The broad framework further helps users through the complicated regulatory landscape that also references previously repealed legislations.
Source: EUCLEF
CLP:
CLP Updates: Guidance Revision, New Proposals, and Open Consultations
On October 2025 ECHA released several updates under the CLP Regulation, including new guidance, classification proposals, and a withdrawal notice.
Updated Guidance on Annex VIII
ECHA published the sixth version of the Guidance on Annex VIII to CLP, clarifying new provisions related to harmonized information for health emergency response. This update aims to support better compliance and communication for poison center notifications.
New CLH Proposals
Three new proposals for harmonized classification and labelling have been submitted for:
- Penoxsulam (ISO) – EC -, CAS 219714-96-2
- m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline – EC 275-662-9, CAS 71604-74-5
- p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline – EC 225-716-2, CAS 5026-74-4
(Note: Some identifiers are pending confirmation.)
Withdrawal of CLH Proposal
The classification proposal for methyl 4-hydroxybenzoate (EC 202-785-7, CAS 99-76-3) has been withdrawn.
Public Consultations Open Until 19 December 2025
ECHA invites comments on new CLH proposals for:
- 1-methylimidazole (EC 210-484-7, CAS 616-47-7)
- Imidazole hydrobromide (EC 483-310-2, CAS 101023-55-6)
Stakeholders are encouraged to contribute scientific or technical information to support decision-making on these substances.
Sources: ECHA, CLP Guidance on harmonized information
