(June 10, 2015)
Our analysis of recent published survey - which was initiated by the European Association Medical Device Notified Bodies (TEAM NB) - identified continuous trends towards of:
- increasing number of certificates being withdrawn;
- decreasing number of new conformity certificates issued; and
- increasing number of staff (fte's).
A more in-depth analysis shows statistical significant correlation between 'certificates withdrawn' and 'number of staff NB' .
Analysis of abovementioned identified trends and correlation gives us the following explanations of these features:
- All notified bodies are auditing with stricter enforcement against the EU medical device directives (MDD, AIMDD, IVDD).
- There is a stricter enforcement of various regulatory requirements by National Competent Authorities (CA) and notified bodies, i.e.
- additional requirements on clinical data in the content of clinical evaluation reports;
- requirements relating to planning regarding post-market clinical follow up;
- increased number of unannounced inspections and audits;
- increased control of outsourced processes and supply chain management;
- increased control of post market.
- Manufactures and stakeholders experiencing increased unexpected costs of product certification caused by i.e.
- total audit days,
- additional consultancy support, and
- enhance workload of the QA / RA representative.
These causes may lead to a increased number of non-payment of performed audit and or delay in payment invoices of NB.
- An limited number of mergers and acquisitions may had influence on identified trend data.
- Discontinuation of business activities due strategic economic decisions by manufacturers and or their investment companies.
- Analysis of internal notified body processes and subsequently 'process improvements' to be in compliance with the new Medical Device Regulations (MDR), In Vitro Diagnostic Regulations (IVDR), and ISO 13485:2016.
- Outcome of internal notified body training sessions as a significant step in further professionalization of medical device auditors and their staff.
One cause of all these changes can be found in i.e. the Poly Implant Prostheses (PIP) breast implant scandal what highlighted the consequences of extreme non-compliance. In this particular case the criminal approach of the manufacturer severely impacted the health and wellbeing of many women. It is therefore not surprising that stricter enforcement and additional rules for the market surveillance and the quality and power of inspections/product testing are revisited in the new MDR, IVDR, and the ISO 13485:2016.
The call for stricter rules to ensure the validity and power of clinical data is not new. The initial intention to promote harmonization of the requirements and approvals of clinical investigations was present in the implementation of the amended EU Directives in 2007 in the laws of the EU member states with due date March 2010. Nevertheless, there is still considerable inconsistency in the approach and requirements of competent authorities and ethics committees in the different member states. An enhanced degree of regulatory harmonization in the EU to remain an attractive environment for international clinical studies may be an add value in the development process of innovative medical devices.
Companies, in particularly manufacturers, need to anticipate and prepare to deal with the new situation and with proposed changes in the MDR, IVDR and ISO 13485 in a pro-active and timely manner to avoid having CE certificates suspended or revoked because they were unable to comply with the new regulatory requirements in time. These changes will require significantly higher investment from companies to be and to maintain in compliances of EU regulatory requirements.
We 're looking forward to support you in implementing all new regulatory requirements in your organization on a sustainable methodology. Our total service concept is build on Training, Project Management Technical File / Quality Management, Communication, and Consultation. We understand that you as medical device company need to be prepared on time to abovementioned changes to protect your assets and to manage your organization in a effectively and efficient way. The 'classical' role of QA / RA representative will be diminished and a need for professional and integrated support will be helpful.
