Team NB Publishes Press Release on Certificates with Conditions
On 12 March 2025, the TEAM NB issued a press release on certificates for which special conditions, regulations or even restrictions can be invoked in accordance with EU MDR 2017/745 and EU IVDR 2017/746 Annex VII Section 4.8.
ISO 15223-1 First Amendment Published
The harmonized standard ISO 15223-1 defines the symbols used by medical device manufacturers to label and communicate important information.
Update on the Medical Devices Operator Ordinance (MPBetreibV) and Medical Devices Dispensing Ordinance (MPAV)
Germany amends the Medical Devices Operator Ordinance (MPBetreibV) and Medical Devices Dispensing Ordinance (MPAV)
New Regulation (EU) 2025/40 on packaging and packaging waste
The EU adopts a new Regulation (EU) 2025/40 on packaging and packaging waste, which introduces stricter obligations focused on a circular economy.
MDCG guidance alert: New MDCG 2024-16 guidance on how to deal with interruption or discontinuation
New MDCG guidance provides an information form for MD and IVD manufacturers to complete in case of supply interruption or discontinuation.
MDCG 2022-5 Rev.1: Updated guidance on borderline products
Revised MDCG 2022-5 Rev.1 aims to improve classification of borderline products with new examples and explanations.
MDCG 2024-13: Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices
MDCG 2024-13: EtO is subject to the MDR/IVDR, although EtO as a substance does not require additional conformity assessment.
TEAM NB press release on transition to the implementation of Class D IVDs oversight by EU reference laboratories
Class D in vitro diagnostic medical devices must be tested by an EU reference laboratory laboratories designated by the European Commission
MDCG 2021-25 Rev. 1: MDCG publishes revised guidance on the application of MDR requirements to legacy devices
MDCG revises its guidance on the application of MDR requirements to legacy devices
MDCG 2024-12 Rev. 1: MDCG revises its guidance on CAPA plan assessment
MDCG revises its guidance on corrective and preventive action plan assessment, including templates
