Several times in 2013, I encountered some new wrinkles in EU member state interpretations of compliance with EU new approach directives. The first example involves medical device classification and the second involves member state oversight of the Low Voltage Directive, which I will address in my next Blog.
Medical Device Classification
Last year I talked with a medical device company that had been informed by a major EU Competent Authority that their Medical Devices Directive Class I self-certification was incorrect. Instead of Class I, they were informed that the inclusion of a battery in their device moved it into Class IIa. This meant that they would have to manufacture their device using a notified body certified ISO 13485 Quality Management System.
Willing to certify their QMS, but unhappy with the delay in marketing, they connected with a representative (how, I don’t know) from a small EU member state who said he would present their situation to his Competent Authority who then granted a one year CE Mark to the company (this was a new twist). They approached the same representative in 2013 asking if they could extend their Class I CE certification for an additional year, which I assumed was granted.
I found this to be disconcerting. I hadn’t expected one member state Competent Authority to negate or override the decision of another Member State Competent Authority. It implies that CE certification is negotiable, if you knew the right person connected with the right Competent Authority. I have no idea how prevalent this practice is but it does cast doubt on the integrity of some aspects of CE Marking Medical Devices in the EU.
After the French silicon breast implant debacle that has caused thousands of anguished women terrible pain and expense from a manufacturer who knowingly substituted industrial grade silicon for medical grade silicon, the EU has been reviewing its Medical Device regulatory scheme with an eye to updating its approach to medical device regulation. One immediate problem that must be addressed is the plethora of third parties (estimated at 80 to120) approved and notified to the European Commission by Member State Competent Authorities to oversee the administration of the EU Medical Devices Directives. Many of these notified bodies do not possess the expertise to competently oversee all of the aspects of medical device manufacturing. I discussed this issue in my January 31, 2012 Blog, “Notified Bodies and CE Marking – Potential Legal Issues in US Lawsuits #4”
On 26 September 2012 the European Commission published several papers discussing the revision of the Medical Devices Regulatory Framework: Commission Staff Working Document, Executive Summary of the Impact Assessment of the Revision of the Regulatory Framework for Medical Devices; Commission Staff Working Document; Proposal for a Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009; Communication From the Commission to the European Parliament, The Council, The European Economic and Social Committee and the Committee of the Regions – Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professional
In short, a thoughtful deliberative process is actively underway to improve the oversight and regulation of Medical Devices in the European Union. I assume that Competent Authoritiy's intruding on the decisions of their counterparts will not be permitted in the future, at least I hope not.
The European Commission’s Citizens’ Summary of the EU proposals on Medical Devices put together a list of changes that is useful to examine:
What Exactly Will Change?
- Wider, clearer scope for EU legislation on medical devices – extended to include, for example, implants for aesthetic purposes and clarified as regards genetic tests
- Stronger supervision of independent assessment bodies by national authorities
- More powers for assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections
- Clearer rights & responsibilities for manufacturers, importers and distributors which would also apply to diagnostic services and Internet sales
- Extended Eucomed database on medical devices – will provide comprehensive information on products available on the market. Non-confidential data will be publicly available
- Better traceability of medical devices throughout the supply chain – enabling a swift and effective response to safety problems (e.g. recalls)
- Stricter requirements for clinical evidence to support assessments of medical devices
- Updated classification rules defining medical devices into 4 different risk categories and health & safety requirements, including labeling rules – to keep pace with technological and scientific progress
- Better coordination between national surveillance authorities, with the Commission providing scientific, technical and logistic support
- International guidelines to be incorporated into EU law
While it remains to be seen how effective these changes will be, there is cause for optimism. Creating a regulatory scheme for a 28-member state European Union is a formidable task. Creating a Notified Body structure that will have the competence to effectively regulate medical devices is a significant step forward.
I will continue examining progress in future Blogs. My primary focus is on International Regulatory Compliance, which includes both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal Court or state courts. I focus on product safety, product liability and the steps necessary to create a safe product. I also serve as Legal Expert/Expert Witness where safety has been compromised or ignored resulting in damage and/or injury. If you have questions regarding ISO 9001, FDA’s Quality System Regulation or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address email@example.com