EU Medical Device Regulations
Are you prepared for the IMPACT ?
2016 – Year of Change for Medical Device Companies
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 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 .
Changes in key areas 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 subjected 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 in such delays to product development lead times .
The changes due to be implemented in 2016 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 .
70 years of experience NSF Health Sciences can help in this process . With over 70 years of experience in helping medical device companies and other organisations 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 .
For more information , contact NSF Health Sciences
NSF Health Sciences – Medical Devices Advanced Manufacturing Park Brunel Way Rotherham South Yorkshire S60 5WG Tel . ( 44 ) 1142 541 270 eudevices @ nsf . org www . nsfmedicaldevices . org