Medical Device Regulation

Writing Standards

What are Standards for?

Standards are an important way for manufacturers to show their products comply with EU Law when they bring them to market. They are in fact voluntary. A manufacturer can show they comply with legislation in other ways for example directly addressing the requirements of the legislation. But Standards help manufacturers meet legislative requirements, which in turn makes for simpler legal compliance. If a manufacturer does not use a relevant Standard, the regulators may look more closely at product.

Who writes the Standards?

Standards are written by stakeholders with an interest in the particular area. This is usually industry, but can also include health-care professionals, academics and patient groups, for example.

The drafting process works on three levels:

  1. Global (e.g. IEC-ISO)
  2. European (CEN-CENELEC)
  3. National (BSI, NSAI, NEN)

Who is represented & how does it work?

Nominating organisations (like ABHI) can propose people to sit on a national level Technical Committee (TC) to draft a Standard. It is important that all stakeholders are represented to make sure that all opinions are taken into consideration.

The Technical Committee drafts and reviews the Standard. Members of a National Technical Committee might take the Committee’s view to a higher level (European or Global). Standards are submitted for peer review and comment at various stages in the drafting process.

The importance of engagement

Stakeholders gain a deep understanding of the rationale behind a Standard when they’re involved in drafting. However, there is no payment for attending Technical Committees. The amount of work varies - it could be a couple of days a year attending committees (which are usually in London) and a couple of days of 'homework'. If there is international-level representation, there can be some limited travel and accommodation support.

If anybody who is an ABHI Member would like to be considered for nomination to an Standards Committee please contact Andy Vaughan (Andrew.Vaughan@abhi.org.uk). Interest from SMEs would be especially welcome.