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Technical and Regulatory

The ABHI Technical and Regulatory team focus on monitoring and influencing legislation to ensure a proportionate and appropriate regulatory environment for the medical technology sector.

Areas of activity for the team include:

Medical Devices Directives 

Medical devices are regulated by legislation which is developed in Europe.  The Medical Devices Directives  are transposed into UK law and enforced by the MHRA.  A CE mark signifies that a device conforms to the Directives.  ABHI seeks to ensure that the Directives continue to provide appropriate and proportionate regulation that balances patient safety and innovation and the association works closely with MHRA on matters concerning implementation.

Decontamination and Sterilisation

Decontamination and sterilisation are key topics for many ABHI members.  ABHI engages with the Department of Health, medical device decontamination and sterilisation providers as well as medical device users on many decontamination subjects including prion removal, healthcare acquired infections, and the logistics of moving medical devices along the decontamination chain.

ABHI’s Sterilisation & Microbiology Working Group tracks the development of all the key medical device sterilisation standards, including those covering sterilisers, cleanrooms, disinfectants and antiseptics etc.

Unique Device Identification

Within the next 3-5 years most medical devices will need to carry a unique identifier. This will require major changes in labelling practice and close co-ordination with healthcare professionals and purchasers in the NHS. ABHI is involved in policy development through chairmanship of the Eucomed group which addresses this at EU level and also in the Global Healthcare Standards work of GS1.

Clinical Investigations

ABHI works closely with the MHRA and the Department of Health on a number of areas relating to clinical investigation of medical devices.  The aim is to ensure that the UK and the NHS is an attractive environment for companies to carry out clinical investigations both for regulatory and post-market reasons.

The model Clinical Investigations Agreement (mCIA) was published in November 2008, along with accompanying guidance.  ABHI participated fully in the development of this document which should remove a major administrative hurdle in carrying out investigations in the UK by providing one agreement for use across the NHS.

Click here for copies of these and other documents.

Environment

ABHI monitors that European environmental legislation that has a direct effect on companies’ products.  This principally involves the Packaging & Packaging Waste (PPW) Directive, Waste Electrical & Electronic Equipment (WEEE) Directive, Restriction on use of Hazardous Substances (RoHS) Directive and the legislation on Registration, Evaluation and Authorisation of Chemicals (REACH).  Much of ABHI’s work in this area is in conjunction with Eucomed. 

Standards

ABHI work focuses on standards policy and  management for the industry. This includes, at EU level, membership of Advisory Board for Healthcare Standards UK Market.