Medicines and Healthcare products Regulatory Agency

What's new

• 06 Jan 2009

  Guidance on the medical devices vigilance system for CE marked intraocular lenses

  This guidance document provides advice to manufacturers on the notification of adverse incidents involving intraocular lenses (IOLs) under the Medical Devices Vigilance System. The deadline for comments is 31 March 2009.

• 06 Jan 2009

  Drug Safety Update: Volume 2 Issue 6, January 2009

  The January issue of ‘Drug Safety Update’ includes: drug safety advice for piperacillin/tazobactam generics (their compatibility with other medicines differs from that of the brand leader), and temsirolimus (risk of hypersensitivity reactions with this treatment for renal-cell carcinoma); and a ‘Hot topic’ on European regulation of medicines for children.

• 05 Jan 2009

  MDA/2009/001 - All medical devices

  We are responsible for ensuring that medical devices are safe for patients, health and social care workers and all members of the public. Any failure to report the occurrence of an adverse incident to the MHRA can undermine our efforts to review problems arising with medical devices, and can prevent or delay discussion of corrective actions with the manufacturer.

• 02 Jan 2009

  Information sent to healthcare professionals in December 2008 about the safety of medicines

  A list of letters sent to healthcare professionals in December 2008, to inform of new safety information and advice.

• 31 Dec 2008

  Reclassification of medicines

  We have recently changed the legal status and classification of several medicines.

• 23 Dec 2008

  Results of consultation on amendments to the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994

  We have published the results of MLX 347 which sought your views on proposals to introduce measures in the UK to enforce the obligations set out in Regulation (EC) No. 1901/2006 (the Paediatric Regulation).

• 23 Dec 2008

  Review of the MHRA - Terms of reference

  A review is being undertaken to help identify examples of good practice across the MHRA and recommend where processes could be improved.

• 22 Dec 2008

  MDA/2008/088 - Oxford disposable slings supplied by Joerns Healthcare

  This Medical Device Alert has been issued due to the sling material tearing resulting in the occupant falling out of the sling.

• 19 Dec 2008

  Public consultation on measures to strengthen the medicines’ supply chain

  We have published a consultation document on proposals to strengthen the medicines supply chain in the UK in the light of increasing threat from counterfeit medicines.

• 18 Dec 2008

  MDA/2008/087 - Implantable drug pumps manufactured by Medtronic – SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637

  This Medical Device Alert has been issued due to a risk of delays in the resumption of drug infusion and in the logging of motor stall events following MRI scanning.