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Medicines & Healthcare Products Regulatory Agency

MHRA Issues Guidance on Re-manufacturing Single-use Medical Devices

The Medicines & Healthcare products Regulatory Agency (MHRA) recently released a new guidance document titled “Single-use medical devices: UK guidance on re-manufacturing” published on July 5, 2016 for the purpose of making a clear distinction between re-manufactured single-use devices (SUDs) and devices that are reprocessed or fully refurbished.

MHRA Issues Guidance on Medical Device Standalone Software

On August 25, 2016, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued a guidance covering “Medical device stand-alone software including Apps.” The guidance is applicable to the current medical device directives 93/42/EEC and may be replaced when the new EU Medical Device Regulations are put into force.

UK Medical Device Regulators Introduce “Virtual Manufacturing” to Replace OBL

EMERGO SUMMARY OF KEY POINTS:

  • The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has redefined Own Brand Labeling (OBL) manufacturers as “virtual manufacturers.”
  • UK regulators will begin requiring virtual manufacturers to hold full technical documentation of devices they sell in Great Britain starting September 1, 2017.
  • Any redacted technical documentation from virtual manufacturers due to proprietary data concerns will have to be justified to UK regulators.

Großbritannien: „virtuelle Herstellung“ statt Eigenmarken (OBL)

ZUSAMMENFASSUNG DER WESENTLICHEN PUNKTE DURCH EMERGO:

  • Die Medicines and Healthcare Products Regulatory Agency (MHRA) des Vereinigten Königreichs hat OBL-Hersteller (Eigenmarken) als „virtuelle Hersteller“ neu definiert.
  • Die britische Behörde wird ab 1. September 2017 verlangen, dass virtuelle Hersteller über eine vollständige technische Dokumentation für die Produkte verfügen, die sie in Großbritannien vertreiben.
  • Etwaige Schwärzungen in der technischen Dokumentation der virtuellen Hersteller aufgrund von geschützten Informationen müssen gegenüber den britischen Behörden gerechtfertigt werden.

MHRA Guidance on a No-Deal Brexit

EMERGO BY UL SUMMARY OF KEY POINTS:

  • MHRA will take on responsibility for the UK market;
  • The CE Mark remains valid in the UK and no label changes are foreseen for now;
  • MDR and IVDR will be implemented in the UK in parallel with the EU
  • Non-UK manufacturers placing devices on the UK market need to appoint a UK Responsible Person, a role similar to that of the European Authorized Representative
  • The UK-based manufacturer or the UK Responsible Person must register the device in the UK.

Orientation de la MHRA en cas de Brexit sans accord

Par Ronald Boumans

LES POINTS PRINCIPAUX PAR EMERGO by UL :

  • La MHRA assumera la responsabilité du marché britannique ;
  • Le marquage CE reste valable au Royaume-Uni et aucune modification du label n'est prévue pour le moment ;
  • Le RIM et le RDIV seront mis en œuvre au Royaume-Uni en parallèle avec l'UE
  • Les fabricants non britanniques qui mettent des dispositifs sur le marché britannique doivent désigner une personne responsable au Royaume-Uni, un rôle similaire à celui du représentant autorisé européen
  • Le fabricant basé au Royaume-Uni, ou la personne responsable au R-U, doit enregistrer le dispositif au Royaume-Uni.