FDA have announced a number of reclassifications of Class III devices to lower classifications such as Class II ( with special controls). These include: muscular dystrophy newborn screening tests herpes simplex virus nucleic acid-based assay for central nervous system infections fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies lysosomal storage disorder newborn screening test systems.
Ben KempJuly 4, 2025
Please not the changes being made to UK customs regulations, include postal packet and universal package services, including for items declared as temporarily being in the UK. The Customs (Miscellaneous Amendments) Regulations 2025 This instrument contains various amendments to Customs secondary legislation made under the Taxation (Cross-border Trade) Act 2018 (c. 22) (“TCTA”), and amendments to the Postal Packets (Revenue…
Ben KempJuly 4, 2025
Please note that this consultation closes 11th August 2025. The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing…
Ben KempJuly 4, 2025
Apply for active substance renewal by the deadlines to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadlines are coming up for the following active substance/product type combinations under GB BPR: 27 December…
Ben KempJuly 4, 2025
UK Health Research Authority are requesting feedback by 10th September on guidance to the new Clinical Trials Regulation. Note that the new regulation applies to medicinal products, however clinical trials involving combination products, or using IVDs are in scope, although you have to hunt through the Guidance and find the reference to: Combined trials of an investigational medicinal product and…
Ben KempJuly 4, 2025
Please see this list of FDA consensus standards (updated last month). Of note are the items below including AAMI TIR45 on AGILE practices in software development, and the updated Common Vulnerability Scoring System (CVSS), noting that both 3.1 and 4.0 are recognised, but that the period for which 3.1 is recognised is 7 months then 4.0 is recognised. As usual,…
Ben KempJuly 4, 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its Business Plan for 2025/26, reaffirming its commitment to keeping patients safe and enabling access to high quality and effective medical products through innovation across the UK. The plan appears forward-looking, acknowledging their purpose as an engine of economic growth and the need to be bold and ambitious in the…
Ben KempJuly 1, 2025
Please be advised that Oko Institute, have been appointed as the external consultant to review the June 2025 batch of EU RoHS exemption pack renewals or refusals. If any of these Annex III or Annex IV exemptions are applicable see the table for interested registrants. MedTech Europe usually coordinate responses for the European MD/IVD market. Note that there will need…
Ben KempJune 26, 2025
EU consultation on the harmonization of standards process. EU want feedback by 21st July. Member responses need to constructive rather than a whinge. Standardisation Regulation – revision And Erik Vollebregt’s commentary https://www.linkedin.com/posts/erikvollebregt_standardization-medicaldevices-invitrodiagnostics-activity-7343026050060238848-JDqs?utm_source=share&utm_medium=member_ios&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM I can send this out, but let me know if you want a BIVDA response (this directly impacts NI), and any specific text you’d like to included in…
Ben KempJune 26, 2025