Regulatory Open Forum

The notion of a certification body refusing an ISO 13485 certification at the premarket stage due to lack of sales is contrary to the fundamental intent of ISO 13485, whose intent is the certification of a standardized level of quality assurance before the device is placed on the market.  Moreover, another bottom line for the European jurisdiction is that, as a general rule (there is one exception), the EU MDR does not require the placing on the market of a medical device (regardless of its class) to be held up by, nor contingent upon, an ISO 13485 certification.  I explain these assertions further below.

Demonstration of conformity with applicable quality management system (QMS) requirements (among others) is a precondition for authorization to place devices on the European market.  For example, a European Notified Body (NB) (if one is required at all; I elaborate further on that below) won't issue an EU Technical Documentation Certificate (the most common type of EU MDR product marketing authorization) until after conformity with the QMS requirements has been achieved.  As an aside, Health Canada operates the same way, requiring certification against ISO 13485 (by way of MDSAP) before it will grant marketing authorization for the medical devices governed under the ISO 13485 QMS.  These are just a couple examples of many that we can cite showing that an ISO 13485 certification isn't intended to be contingent on device sales.

In any case regarding Europe, a common misconception is that the EU MDR requires ISO 13485 certification.  But actually, the EU MDR does not require ISO 13485 QMS certification at all (unless the manufacturer voluntarily chooses to leverage Article 8 and a harmonized version of ISO 13485).  Instead, the real requirement is simply that the manufacturer must demonstrate conformity with the EU MDR's various QMS requirements [see EU MDR Article 10(9)].  Indeed, the manufacturer is free to decide whether it will demonstrate such conformity via an ISO 13485 certification or else instead via a non-certified approach.  Accordingly, the placing on the market of an EU MDR Class I self-declaration device (or any other class) need not be held up by, nor contingent upon, an ISO 13485 certification unless the manufacturer has voluntarily chosen to impose the ISO 13485 certification requirement on itself.

Another key point is that ultimately, the standards governing conformity assessment bodies don't require device sales as a precondition for initial certification.  There is however a mandatory two-stage (i.e., two-audit) paradigm for initial certification whereby the manufacturer is required to demonstrate a certain degree of implementation of the QMS (such as performance of a management review).  But device sale is not an intent of the required two-stage audit paradigm governing the certification body and thus its clients.

The notion of a certification body refusing an ISO 13485 certification at the premarket stage due to lack of sales is contrary to the fundamental intent of ISO 13485, whose intent is the certification of a standardized level of quality assurance before the device is placed on the market.  Moreover, another bottom line for the European jurisdiction is that, as a general rule (there is one exception), the EU MDR does not require the placing on the market of a medical device (regardless of its class) to be held up by, nor contingent upon, an ISO 13485 certification.  I explain these assertions further below.

Demonstration of conformity with applicable quality management system (QMS) requirements (among others) is a precondition for authorization to place devices on the European market.  For example, a European Notified Body (NB) (if one is required at all; I elaborate further on that below) won't issue an EU Technical Documentation Certificate (the most common type of EU MDR product marketing authorization) until after conformity with the QMS requirements has been achieved.  As an aside, Health Canada operates the same way, requiring certification against ISO 13485 (by way of MDSAP) before it will grant marketing authorization for the medical devices governed under the ISO 13485 QMS.  These are just a couple examples of many that we can cite showing that an ISO 13485 certification isn't intended to be contingent on device sales.

In any case regarding Europe, a common misconception is that the EU MDR requires ISO 13485 certification.  But actually, the EU MDR does not require ISO 13485 QMS certification at all (unless the manufacturer voluntarily chooses to leverage Article 8 and a harmonized version of ISO 13485).  Instead, the real requirement is simply that the manufacturer must demonstrate conformity with the EU MDR's various QMS requirements [see EU MDR Article 10(9)].  Indeed, the manufacturer is free to decide whether it will demonstrate such conformity via an ISO 13485 certification or else instead via a non-certified approach.  Accordingly, the placing on the market of an EU MDR Class I self-declaration device (or any other class) need not be held up by, nor contingent upon, an ISO 13485 certification unless the manufacturer has voluntarily chosen to impose the ISO 13485 certification requirement on itself.

Another key point is that ultimately, the standards governing conformity assessment bodies don't require device sales as a precondition for initial certification.  There is however a mandatory two-stage (i.e., two-audit) paradigm for initial certification whereby the manufacturer is required to demonstrate a certain degree of implementation of the QMS (such as performance of a management review).  But device sale is not an intent of the required two-stage audit paradigm governing the certification body and thus its clients.