EU Regulatory Resources
AMDR comments to the UK Medicines and Healthcare Products Agency (MHRA)
. . . AMDR does not believe the additional specific [...]
AMDR comments to the Autoridade Nacional do Medicamento e Produtos de Saúde I.P.
AMDR appreciates Infarmed’s decree clarifying Portuguese policy for reprocessing and [...]
Healthcare Without Harm: Measuring and Reducing Plastics in the Healthcare Sector
Plastic has become ubiquitous in healthcare, with a dramatic shift [...]
AMDR comments to the Spanish Royal Decree Regulating Medical Devices
The Association of Medical Device Reprocessors (AMDR) appreciates the opportunity [...]
Latvia: Changes in the legal landscape for medical devices in the Baltics – MDR/IVDR
As well as this, the draft regulations introduce the recycling [...]
Legal Framework: Belgium
Belgium published guidelines for the remanufacturing of single use medical [...]
Legal Framework: Netherlands
The Netherlands published guidelines for the remanufacturing of single use [...]
Legal Framework: Germany
The legal basis for reprocessing under German law (MP Betreiber V) changes on [...]
European Commission’s Medical Device Sector, Reprocessing of Single-Use Devices Page
‘Reprocessing’ refers to a process carried out on a used [...]
AMDR Response to Swedish MedTech Shadow Report
In December 2020, the Swedish National Board of Health and [...]
AMDR comments to the Slovenian Ministry of Health Proposal
The Association of Medical Device Reprocessors (AMDR) appreciates the opportunity [...]