2017: MDR and IVDR challenge

2017 is going to be a memorable regulatory year within the medical device field. As we want to highlight  a few major issues that will affect manufacturers of ALL medical device risk classifications

 

Risk Class I medical devices and self-certifiable In Vitro Diagnostic devices(IVD):

  • The era of Risk Class I devices and IVD’s not being subjects to audits is over. The National Competent Authorities (NCA’s) decided that in the absence of Notified Body audits for these devices they will be performing Compliance Inspections at the EU manufacturing level or at the Authorized Representative level for non-EU manufacturers.
  • The audits focus on completion of technical files. While the audits are friendly enough, they are performed for the purpose of enforcement. No remediation period is extended to address any non-compliance issues, it leads to immediate fining. Several companies are already on the receiving end of fines varying from 50,000 to 150,000 Euros.
  • This makes inspections for Risk Class I devices and self-certifiable In-Vitro Diagnostics by the NCA’s tougher than audits by a Notified Body for the higher risk classifications.     

 

Notified Body changes:

  • Notified Bodies are no longer friendly commercial organizations that you contract with to audit your compliance with the Medical Device or In-Vitro Diagnostic Directives.  Under the new  medical device regulations (MDR) they change to for profit enforcement agencies.
  • Notified Bodies are under extreme pressure preparing for the new Medical Device and In-Vitro Diagnostic Regulations (MDR / IVDR) set to be published as of April of 2017. There used to be 83 Notified Bodies, as of this month there are only 53.  Further reduction is expected.
  • Notified Bodies need to hire and train auditors and staff with higher competence and higher expertise, resulting in higher salaries roughly estimated at 50%. Leading to higher costs for manufacturers.
  • In an attempt to find new staff and auditors Notified Bodies are ‘stealing’ auditors from each other or from industry. Industry is looking for replacements of lost knowledgeable staff members and is ‘stealing’ personnel from Notified Bodies . Competent Authorities and the European Commission are also looking for more staff members. The big problem is that medical experts are not exactly looking for new jobs and are happy where they are.  This is going to create a BIG Shortage of Notified Body services …

 

Summary:

  • This is not the time to consider a change in Notified Body. Manufacturers perceived as ‘problem accounts’ will most likely be ‘cancelled’ or ‘not renewed’ by Notified Bodies. Applying to a different Notified Body will be most difficult if not impossible especially for SME’s. There is no recourse for the resulting loss of EU sales. These agencies simply do not owe manufacturers a path to a CE certificate.
  • The best prevention is tough internal audits that do not leave findings for Notified Body auditors or National Competent Authority inspectors!
  • 2017 will be the ‘regulatory enforcement and change’ year in European Union!

Whitepaper