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Information for clinicians and patients.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
For manufacturers reporting adverse incidents with joint replacement implants under the vigilance system.
Information for healthcare professionals, patients, and the public.
An interim report from the Scottish independent review of the use, safety and efficacy of transvaginal mesh implants.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Amended advice on the insertion site for Nexplanon contraceptive implants following concerns regarding reports of neurovascular injury and implants migrating to the vasculature (including the pulmonary artery).
All healthcare professionals trained in inserting Implanon must make sure they are trained in using Nexplanon before the changeover.
There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery. An implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at the...
Unknown risks following distribution of product after CE certificate withdrawal
Manufactured by Synthes GmbH – cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing.
(Poly Implant Prothese (PIP)) advice for implanting surgeons to identify women with PIP implants and advise them that further testing will be carried out. (MDA/2010/078)
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
(Poly Implant Prothese (PIP)) French medical device regulatory authority (AFSSAPS) found the composition of silicone gel for most breast implants have been different to the one approved since 2001 (MDA/2010/025)
Manufactured by Coloplast A/S – temporary suspension of the CE certificate due to particles found on some implantable devices made by their subcontractor Silimed lndustria de lmplantes Ltda - MDA/2015/036
UK update on Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL)
(All) uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast - none reported in the UK. (MDA/2011/017)
(All) risk of pneumococcal meningitis in cochlear implant patients. (MDA/2006/019)
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