Ever since the Poly Implant Prothèse (PIP) breast implant scandal in 2010, the focus on medical device regulation has been gathering momentum, both within regulatory bodies and medical device companies themselves. This will eventually manifest itself later in 2016 when the industry will see a significant tightening-up of the regulations in what is being seen as the most sweeping set of changes since the 1990s. The changes to the Medical Device Directive and ISO 13485 will require companies to plan carefully to ensure they fully understand the implications.

The changes will be in a number of key areas that will require manufacturers to reassess their business strategy. As an example, certain products are likely to be re-classified to a higher category, which will demand greater scrutiny by notified bodies . In the case of products re-classified to Class III, a design examination certificate is only issued when documented reviews of all design changes have been carried out. Also, manufacturers will be subject to unannounced audits and every device will need a unique device identifier (UDI), which will require a renewed focus and significant additional resources to ensure the new measures are in place and effective. Some of the most significant changes will be experienced by IVD manufacturers, with many more now being subjected to notified body scrutiny.

Whereas manufacturers will be most heavily impacted by the changes, notified bodies themselves will also be subject to additional oversight by competent authorities such as the MHRA. In effect, notified bodies will need to submit to additional scrutiny from national authorities when reviewing technical documentation prior to the CE marking of a given product. This is likely to result in an extended submission process and require manufacturers to build this timing to product development lead times.

The changes due to be implemented later this year will have wide-ranging implications for medical device manufacturers. The impact will be felt right across the business. Key functions responsible for implementing the new requirements such as regulatory affairs, quality assurance and new product development will need to fundamentally reassess their approach. But the ripple effect will also touch finance, legal services, clinical, sales and marketing and logistics.

Medical device companies likely to fare best within the new regulatory landscape are those that make sure they understand the changes, plan early and involve multidisciplinary teams in ensuring compliance. An ideal approach is the development of a business impact analysis that can highlight the actions required and how the overall business cycle will be affected.

NSF Health Sciences can help in this process. With over 70 years of experience in helping medical device companies and other organizations meet local requirements, NSF can help turn new regulatory requirements into an opportunity to get ahead of the game. NSF can not only provide consulting services that help formulate the optimum approach within key functions – it can also offer auditing services to check the level of preparedness and expert training services to ensure that compliant systems and processes are sustained and appropriate behaviors are embedded. Training can be provided at scheduled public courses or tailored and delivered in-house to suit particular company requirements.

NSF Health Sciences Europe can be contacted at:

NSF Health Sciences – Medical Devices
Advanced Manufacturing Park
Brunel Way
South Yorkshire
S60 5WG
Tel. (44) 1142 541 270