Gough Square Chambers offers specialist advice on the regulation of medical devices and the Medical Devices Regulations 2002. This includes issues concerning CE and UKCA marking, post-market surveillance, and vigilance obligations. Members are also able to advise on borderline classification questions, particularly where products may fall between medical devices or consumer products.
Chambers offers a deep bench of practitioners with expertise in regulatory investigations and enforcement proceedings. Members have particular experience of interventions by the Medicines and Healthcare products Regulatory Agency (MHRA) and Trading Standards departments. Members also advise businesses in dealing with product safety and product recall issues.
Chambers’ expertise in medical devices regulation sits within its broader market-leading life sciences and consumer regulatory practice. Members are ranked by Chambers & Partners as leading practitioners in Life Sciences Regulatory work.