The industry of European medical device is an essential provider of effective, safe, and innovative healthcare solutions for the majority of patients in Europe. EU Commission started to consider and to evaluate the most appropriate way of coming up with tighter control measures on both the Notified Bodies and manufacturers. After considerable discussions, the EU Commission came up with two essential documents, which were dated on 24th September 2013, and it was in printed on 25th September 2013 in Official Journal. Furthermore, the documents also imposed higher degree of adherence and technical competency to MEDDEV manuscripts on Notified Bodies.
The two documents that were written by the commission included: A) Commission Implementation Regulation No 920/2013 mainly on designation, supervision of Notified organizations in Council Directive 90/385/EEC basically on active implantable medical appliances, and also Council Directive 93/42/EEC exclusive on medical devices. B) Commission Recommendation on assessments and audits performed in the medical device field by Notified bodies. This report is aimed at explaining all the changes that took place in details.
All these changes should be considered in connection to the current legislation.
A) The major changes on quality management systems and audits this stated that; the notified bodies were supposed to assess whether the qualification, organization structure, and competence of staff and managers is enough so as to ensure compliance. In cases where there is major failures in compliances the notified bodies will question the manufacturers so as to know whether they have enough regulatory, technical expertise, or quality within their organization (Goldacre, 2010).
B) The unannounced audit major change included carrying a random check after three years on all manufacturers who are dealing with the manufacturing of medical appliances of all types. Manufacturers dealing with high-risk medical devices and those that fail to comply in most of the times their random checking was to be increased to after every 18 months.
C) The major change that occurred in the department of technical file assessments and documentation was that the Notified bodies expected them to follow NB MED and MEDDEV guidance strictly. This comprised of clear definition of medical purpose, justification of all medical statements, post-market medical follow up, clinical evaluations etc. All these were to regulate manufacturers during the process of manufacturing medical devices (Hitzmann, 2012).
D) One of the major changes that took place in the notified bodies sector was that the surveillance of the Notified Bodies was to include all annual assessments entailing their reviews on manufacturer’s clinical evaluations (Friedman, 2008). E) Major change that took place in the contractual agreements between manufacturers and notified bodies was they agreed to amend and review fixed costs so that the costs can be open ended so as to be able to cover wide ranges of circumstances (Medinfo, 2013). Lastly, the major change that took place in the priorities actions for the manufacturers was that they were supposed to ensure updating of all technical documentation was in line with the new manufacturing practice and device design (Møller, 2007).
In conclusion, the two documents had no transition period and thus they were supposed to be implemented immediately. Additionally, all these changes were made so as to ensure that the service provided and devices manufactured in the medical field were update, reliable and efficient. In addition, to ensure that the complication experienced during the process have been handled in a professional manner.
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