Some Notified Bodies have been forcing a position that medical devices must conform to the latest technical standards to meet European legal requirement for “state of the art”. As a result, some manufacturers have been forced to pay thousands of dollars to retest their products or risk losing their CE mark. The European Commission has received a number of complaints from industry, leading to an investigation and rebuke of this practice of some notified bodies.
NB-MED, which represents a large number of notified bodies and testing labs in Europe posted that “Even if the manufacturer does not use harmonized standards for demonstrating that the medical device meets the legal requirements, the mere fact that a harmonized standard is replaced by another harmonized standard, indicates that the state of the art has changed and that additional effort and evidence will be needed. This state of the art requirement is mentioned in ER 2 of the MDD” – [NB-MED Paper V1.1]1,2
5.6 Alternatives to Recognized Standards
The use of standards is voluntary. Manufacturers should have the option to select alternative solutions to demonstrate their medical device meets the relevant Essential Principles. Manufacturers may use “non-recognised” standards, in whole or in part, or other methods. Alternative means of demonstrating conformity with the Essential Principles may include, for example:
Statements like this one, which relate an expectation that manufacturers retest to 60601-1 3rd edition, have pressed some manufacturers into unnecessary retesting. Such statements present a concern to industry and a frustration for the European Commission. In addition, they ignore the Global Harmonization Task Force (GHTF) recommendations on the role of standards in assessing medical devices (see sidebar).
GHTF Guidance SG1/N044 clearly indicates that a product already on the market does not need to be reevaluated to a newer standard, since it has developed a track record of safety through actual clinical use. The GHTF paradigm follows the view that, if a medical device is safe and effective it will likely continue to be safe and effective.
The European Commission participated in the development of GHTF's Essential Principles, which are nearly identical to the more legally binding “Essential Requirements" of the European Union. The European Commission also codeveloped the GHTF Guidance on the role of standards in assessing medical devices, which includes provisions for assessing against the GHTF Essential Principles using alternative methods.
Speaking on behalf of this issue for the European Commission, Directorate General Manfred Kohler released the following statement October 8th 2012.
The European Commission has repeatedly stated that standards are not mandatory in the EU system applicable to medical devices. Manufacturers may apply the Essential Requirements of the Medical Devices Directives without referring to standards. The only exception to this rule: If manufacturers choose to apply colour coding or symbols, they must use the colour coding and the symbols foreseen in the so-called harmonised standards which are cited in the Official Journal of the European Union. The European Commission follows-up reports according to which some Notified Bodies apply standards on a mandatory basis (beyond the scope of the exception)”
As technical standards are becoming increasingly complicated and larger in scope, the cost of applying standards has become a serious problem for small and medium size companies. The European Commission established that “European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts.”3 These provisions do not merely to make it easier for small and medium size manufacturers to thrive in our healthcare systems, they preserve the healthcare system by sustaining the unique qualities of many devices for which no standard exists. By forcing some standards on medical device industry, we risk forcing these same products out of the healthcare system.
Grant Ramaley is the co-chairman of the Dental Trade Alliance Regulatory Affairs and Standards Committee, and co-convener for the International Accreditation Forum’s Medical Device’s Working Group. Ramaley is director of regulatory affairs at Aseptico Inc.