EMERGO SUMMARY OF KEY POINTS:

• European Member States have adopted a procedure for “orphaned manufacturers” that the Dutch Competent Authority IGJ has implemented already.
• Manufacturers who are affected by the scope reduction of their Notified Bodies can be eligible for a “period of grace.”
• Application needs to be submitted in the European Member State where the manufacturer or AR is based.
• NANDO has been updated with AIMD, IVDD and MDD scopes of NBs.

European Member States are implementing a procedure for manufacturers that no longer have a Notified Body (NB) due to scope reduction or de-notification.

Under certain conditions manufacturers are allowed to keep their medical devices on the European market until their CE Mark certificates reach the end of their initial period of validity, and in all instances within a maximum limit of 12 months following the de-notification or effective end of activities of their erstwhile NBs.

In this blog post, we will explain how to apply for this “period of grace” and what is needed in order to be able to keep marketing your device in Europe.

Scope reduction and de-notified NBs

After the PIP affair involving fraudulent use of non-medical grade silicone breast implants, the European Commission and the EU member States adopted a Joint Plan for Immediate Action under existing Medical Devices Legislation (the so-called “PIP Action Plan”).

The action plan was aimed at improving control of NBs through the Medical Devices Directive 93/42 EEC (MDD), the Active Implantable Medical Devices Directive 90/385 EEC (AIMD) and the In Vitro Diagnostic Medical Devices Directive 98/79 EC (IVDD). In line with the aforementioned plan, European Competent Authorities performed joint assessments of NBs to assess whether such entities designated under the Medical Devices Directives were (still) competent.

Between 2014 and 2017, NBs were assessed, which led to scope reductions and even the withdrawal or suspension of some NBs through a process known as scope reduction and de-notification.  In 2014 there were 78 NBs designated in Europe; this amount has fallen drastically to 51 NBs in 2017. Some NBs decided to discontinue operations, while others were suspended in accordance with the joint assessment. An updated list of NBs and their scopes has recently been published by NANDO.

Manufacturers may be affected if their NB is suspended or is no longer allowed to perform certain audits or issue CE Mark certificates because of a scope reduction; these firms are referred to as “orphaned manufacturers.” Without a valid CE certificate, marketing of a medical device or IVD is not allowed in Europe, and therefore has a major impact on the business of affected manufacturers.

Period of grace

In order to continue marketing your products in Europe, you must have a valid CE Mark certificate. European Member States have adopted a procedure that allows a grace period for orphaned manufacturers in the event of an NB’s de-notification or scope reduction. The Dutch Health Care Inspectorate (IGJ) has already implemented this procedure (link in Dutch). Manufacturers may apply for a period of grace if they or their Authorized Representatives (AR) are based in The Netherlands. If approved by IGJ, the grace period allows manufacturers to keep devices on the market under certain conditions until the CE Certificate issued by the de-notified NB expires, up to a maximum of 12 months.

What is requested?

First, as soon as possible, but not later than four weeks after becoming aware of your NB’s scope reduction or de-notification, you should inform the IGJ that you have been affected. In addition, the following documents need to be provided to IGJ:

• Overview of all affected devices including their CE certificates,  as well as sales data over the past 36 months for each Member State where your device is sold;
• Statement of maintenance of your quality management system during the period of grace;
• Information regarding recertification by a new NB, timelines, audit dates, etc.
• Vigilance SOP and Post Market Surveillance SOP, including the most recent vigilance and PMS report where applicable, and most recent management review;
• Overview of all vigilance cases related to the affected devices over the past 36 months (across all markets where the device is sold);
• Overview of all ongoing or completed CAPAs in response to incidents over the past 36 months (including reason, possible root causes, conclusions and solutions).

Not marketing anymore?

Please note that regardless of whether you plan to apply for a period of grace, you or your AR need to inform the relevant Competent Authorities in case you are affected by a scope reduction or de-notification of your NB.  This procedure has been implemented and is required by all European member states.

Annette van Raamsdonk is Regulatory Affairs manager at Emergo in The Netherlands.

Additional European regulatory resources from Emergo:

• European CE Marking strategy consulting for medical device companies
• On-site Medical Devices Regulation (MDR) training
• Webinar: How to select or change your Notified Body