Podcast Location:
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Clinical Negligence
Personal Injury
CPD Points:
Up to 1 point. details »

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Regulated by the Solicitors Regulation Authority:
Listen and pass the quiz: Gain 1 CPD point (60 minutes)
Listen only, gain ½ a CPD point (30 minutes)

Regulated by the Bar Standards Board:
Listen and pass the quiz: Gain 1 accredited CPD point (60 minutes)

Regulated by ILEX:
Listen and pass the quiz: Gain 1 CPD point (60 minutes)
Listen only, gain ½ a CPD point (30 minutes)

  • FREE
30 minutes of audio
(+ optional 5 minute online quiz)
Plays on Computer:
Yes Downloadable as MP3:    Yes
Course Aims:

This podcast is aimed at practitioners interested in medical law issues or those practising in the fields of personal injury, product liability or clinical negligence. It explores two aspects of the recent scandals involving PIP breast implants and metal-to-metal hip replacement implants; firstly the regulatory structure of the medical devices industry and secondly the possible civil legal remedies that may arise from dissatisfied patients.

After completing the course you will:
  • Understand what a medical device is;
  • Understand how medical devices are regulated at a European and national level;
  • Understand the possible areas in which the regulatory regime for medical devices might be improved for the benefit of patient and product safety;
  • Be aware of the relevant details concerning the recent breast and hip implant scandals;
  • Understand to what extent faulty medical devices are an issue of product liability or personal injury law;
  • Be aware of the relevant tortuous and contractual claims that may be made on health professionals responsible for fitting medical devices that turn out to be faulty;
  • Be aware of the current state of the law so far as effective remedies for the removal and/or replacement of medical devices are concerned.
General Interest Difficulty: 2 of 5
Legal Principles
Market Update / Hot Topic
Sources and References:
  • Medical Device Directive 93/42/EEC;
  • Implantable Medical Device Directive 90/385/EEC;
  • In Vitro Diagnostic Medical Devices Directive 98/79/EC.

In the wake of revelations in early 2012 concerning PIP breast implants and medical complications arising from metal-to-metal hip replacement implants, this podcast reviews the legal and regulatory framework governing so called ‘medical devices’, exploring its deficiencies and what personal injury or clinical negligence issues might arise as a consequence.

Podcast added: 01/03/12

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