MHRA

Brexit: The Hard Reality of “No Deal” for the Medical Device Industry

EMERGO SUMMARY OF KEY POINTS:

  • All economic operators in Europe, the UK and in the rest of the world may face significant consequences of Brexit.
  • The distribution network of medical devices currently placed on the market by UK based importers must be reviewed.
  • EU distributors currently placing UK manufactured devices on the market may have a different role.
  • Unless a fitting deal has been made, all certificates issued by British Notified Bodies on EU regulations/directives will become void from 30 March 2019.
  • Notified Bodies are already anticipating this scenario.

UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Human Factors Engineering (HFE) guidance from the UK MHRA differs in some areas from recommendations issued by the European Union.
  • The MHRA focuses its recommendations on HFE and usability engineering during medical device development.
  • In some areas, the MHRA guidance hews closer to US FDA recommendations than European standards.

UK, European Device Industries Urge Continued Regulatory Alignment Post-Brexit

EMERGO SUMMARY OF KEY POINTS:

  • UK and European medical device and IVD industry trade groups are arguing for full MDR and IVDR implementation in Great Britain during and after Brexit negotiations.
  • The groups seek European recognition of UK Notified Bodies and Authorized Representatives as well as full access to the Eudamed database by the UK MHRA.
  • Whether Brexit negotiators adequately address the trade groups’ concerns remains an open question.

UK Regulator Launches Interactive Guide to New European Medical Device, IVD Regulations

EMERGO SUMMARY OF KEY POINTS:

  • A new interactive online guide from the UK MHRA provides high-level overviews of new European medical device and IVD regulations.
  • The new guide should prove useful for CE Mark certificate holders has they prepare for full compliance with the Medical Devices Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).

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.

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.

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.

British Regulators Launching Online Registration System for Class I Devices

The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on February 11, 2015.

UK Regulators Requiring Public Registration of Medical Device Clinical Investigations

Healthcare regulators in the UK are now requiring medical device manufacturers and sponsors to register their clinical trials in publicly accessible databases such as the EU Clinical Trials Register or ClinicalTrials.gov in the US.

UK Regulator Opens New "Office" for Innovative Medical Devices

The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK medical device market regulator, has set up an “innovation office” in an effort to provide a more efficient market authorization process for manufacturers of cutting-edge products.

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