Recent changes in the certification of medical devices in the EU have had a significant impact on manufacturers and critical suppliers, with decreases in numbers of notified bodies. Tina Lochner and Klaus-Dieter Ziel of MEDCERT explain how to navigate this new market.
Among the first organisations to enter the market 22 years ago, MEDCERT is one of the largest notified bodies (NBs) in Germany, and one of the top 15 NBs active today. Headquartered in the north of Germany, MEDCERT operates internationally, with independent subsidiaries in the US, China and Malaysia. A specialist for medical device market approval (CE marking) and quality system certification (ISO 13485) for almost all types of medical devices, MEDCERT provides customers looking for meaningful, valuable and reliable certification with access to local competence and the synergy of its global network. Its NB identifier is 0482.
Without a doubt, manufacturers, suppliers and distributors of medical devices and components have recently experienced drastic changes in the path to European CE marking and QMS certification. Marked by the 2012 breast implant scandal, a new era began for European medical device market approvals, with the European Commission implementing regulation 920/2013, effective from December 2013. A direct outcome of the commission's joint assessment of NBs has been an ongoing decrease in NB numbers and accreditation scopes, and an increase in unannounced audits of manufacturers and respective critical suppliers by NBs.
Differences in bureaucratic burden and the interpretation of requirements by individual NBs are diminishing, as sincere organisations adhere to IAF guidance MD9 for the determination of audit man-days and IAF guidance MD2 for the handling of NB transfers. Given that the EU has not implemented a predicate device category for approvals that makes almost all certification projects (regardless of their risk class) unique and often presented with their own challenges, it is clear that timeliness - not speed - of certification is the name of today's certification business.
While most manufacturers are accustomed to selecting and evaluating their suppliers and subcontractors based on price and quality, choosing an NB should be based on a number of additional factors. In light of the changes mentioned above, all medical device manufacturers - including virtual and component manufacturers, PLMs, OEMs, and critical material, technology and service suppliers - should ask NBs a number of questions:
Now, more than ever, manufacturers need to secure NB services far in advance. It is expected that, in addition to the approximate 20% of NBs that have already dropped out, more will cease to exist, eventually reducing the number by up to 50%. Certification costs and fees, as well as turnaround time, will continue to increase; in worst-case scenarios, these factors will rise by 50-100%, making it necessary for manufacturers to reconsider their need for European certification and adopt much more careful strategies to obtain market clearance. While one-stop-shops and single audit programmes seem attractive, this convenience may come with significant price tags, the burden of having to manoeuvre overwhelming bureaucracies and the implementation of additional administrative requirements without gaining actual, bottom-line benefits.
Legal manufacturers need to demonstrate their ability to produce and deliver safe medical devices at all times, by providing objective evidence of adequate controls across their supply and distribution chains. Manufacturers and critical suppliers alike must demonstrate that applicable requirements, obligations and duties (with respect to production, processing, packaging, labelling and shipping of medical devices - and respective accessories - as well as market surveillance and notification) are clearly and explicitly defined in respective agreements between the corresponding parties.
Submission of adequate and complete technical documents for devices, subject to CE marking, remains a challenge for many companies, particularly in future PLM-OEM scenarios. MEDCERT pledges to accompany its clients through every stage of the certification process with fairness, transparency and competence, always considering the best solution for its customers.