Access to notified bodies research and market engagement 2016

The report outlines a research project undertaken for Scottish Enterprise (SE) between July and October 2016, which sought to understand the challenges faced by Scottish companies around securing the services of notified bodies. This research sought to investigate claims from the market of insufficient supply and barriers to access for Scottish medical technology (medtech) companies seeking these services. The report also provides a demand model for the services of notified bodies in Scotland, incorporating both current and future demand.

The methodology consisted of primary research with a range of Scottish medtech companies and interviews with four of the five notified bodies currently operating in the UK.

The research found that there are a number of challenges facing companies wanting to access notified bodies. Some of these include: the current pressure on the capacity of notified bodies in the UK and EU; the decreasing number of notified bodies available; the uncertainty around Brexit and whether notified bodies in the UK will be allowed to administer product certification (CE marking), or whether as a consequence, two different accreditation systems will be required; and the uncertainty over the new European medical device regulations. A key finding of the interviews with medtech companies was that there can be a disjoint between the understanding of the CE marking process between operational staff and board members, which presented a challenge. Having board members with current experience of securing regulatory certification in industry tended to resolve this issue. Despite some challenging relationships being cited, none of the companies spoken to had switched notified bodies. There was an understanding that many issues exist at an industry level and starting again with a new provider was often considered too costly. Notified bodies were also found to face a number of challenges in relation to: the retention and recruitment of auditors; dealing with changes in membership within the EU; and coping with the changes and complexity of EU directives. The demand model found that the current and future demand for notified body services does not justify investing in a new notified body to serve Scotland.

The following recommendations were made: consider auditor training to increase the number of auditors available; undertake more work to learn about the upcoming changes that the impact the new directives will have on the medtech industry; increase awareness of the medtech community regarding how notified bodies operate and how to engage with them; and increase awareness of the medtech community regarding device classification and regulatory requirements.