Andy Vaughan

Andy Vaughan has been the environmental consultant for Eucomed since January 2009. Previously, he trained electronics engineer, specialising in control electronics, he rapidly moved into medical devices. He spent his early career working in hospitals as a member of a medical device maintenance group, subsequently specialising in diagnostic ultrasound whilst working in a company which was one of the first to import this new technology into the UK from Japan. When the company decided to set up a European support centre in the Netherlands, Andrew was taken on as the European technical expert covering Europe, the Middle East and Africa.With the advent of the Medical Device Directive, Andrew found himself becoming increasingly involved in regulatory issues until the workbench became a distant memory. He returned to the UK with his new regulatory skills working with the UK subsidiary of another Japanese company. With the increasing importance of environmental issues, Andrew then became more involved with this aspect of the industry, eventually becoming the Group Environment Manager.

The long anticipated revision of the Waste Electrical and Electronic Equipment (WEEE2) Directive (2012/19/EU) was published in the Official Journal, L197, on the 24th of July 2012. The Directive arrives just over a year after its sister Directive 2011/65/EU on the Restriction of Hazardous Substances (RoHS2). The stated aim of WEEE2 is to:
The European Commission published on 1 June its long-awaited regulation proposal on European standardization. The document consists of the proposed legislative measures which update and consolidate existing EU legislation as well as impact assessments and non-legislative measures such as a strategic vision for European Standards. There were also a number of recommendations aimed at other actors in the EU Standardization system. I am convinced that these proposals are a significant step forward in the development of standards as an essential tool in developing the EU single market.
Everybody who has anything to do with electrical medical devices has been watching with interest the progress of the WEEE (Waste Electrical and Electronic Equipment Directive) and RoHS (Restriction of Hazardous Substances Directive) Directives through the European political process. RoHS, which should soon be published in the Official Journal of the European Union, has been especially important as the latest iteration of the Directive will see medical devices falling within its scope from about April/May 2014.
There are some who are claiming that the EU Commission’s formal objection to eleven standards raised at the end of last year shows that the ‘New Approach’ has shortcomings and that the whole system is ripe for overhaul. I would argue far from it. The New Approach is a very clever system of product regulation, directing resources to where they are most needed while allowing manufacturers to innovate and permitting innovative medical devices to get to patients sooner and with no decrease in safety. The New Approach has shown itself to be a very flexible and efficient method of ensuring safe products reach the patient. What the EU Commission ‘formal objection’ does illustrate is a system that is ‘growing up’ and having to work with more globalised and integrated world economies. The concept of the ‘New Approach’ was, and still is, revolutionary. All medical devices, from the lowly Class 1 tongue depressor, to the most sophisticated Class III heart valve, and everything in between, has to be safe and meet the ‘Essential Requirements’ of the Medical Device Directive. Mapped on top of this is a risk-based oversight from the authorities, thus ensuring safety and the most efficient use of government resources. Standards currently form the backbone of the system and although voluntary, provide a foundation on which manufacturers can design and manufacture their devices. Harmonised standards provide a convenient route to demonstrating compliance with the regulations. But we shouldn’t let convenience slip into complacence. One of the interesting things to come out of the formal objection is the almost complete indifference by some manufacturers to whether standards are harmonised or not. The rationale is interesting. ‘Regulatorily sophisticated’ manufacturers use standards as a road-map to generating the safety data necessary to meet the Essential Requirements. They understand that the target is...