EU regulatory authorities are starting to take action to prevent hundreds of products from being unnecessarily withdrawn from the EU market following the exit of notified bodies from the medtech sector. But will this practical solution mean some CE-marked products will be floating freely around Europe with no notified body backstop?
An increasing number of EU notified bodies are ceasing operations or having their scope restricted in the medtech space due to either a lack of resources to manage the increasingly tight requirements, or because they have failed assessments and have been "denotified."
But what is happening to the products for which these notified bodies have granted certificates? Are they allowed to remain on the market? And who has responsibility while the companies seek another notified body to take on responsibility for those products? These are critical questions that more and more device manufacturers are facing.
From a regulatory point of view, the validity of EC certificates during such a transitional period has not been fully clarified. But it now seems that the at least some regulators – aware of the problem and its urgency – are supporting an approach that allows a grace period for manufacturers left orphaned by their notified body, unless particular circumstances offer a reason not to provide this flexibility.
This grace period, however, might undercut the EU movement to tighten control over medical devices, some say. Should products, which are CE-marked and which bear the number of the notified body that assessed them, be allowed to circulate with no notified-body backstop? Have the authorities enough resources to oversee this situation across the EU?
The Practical Solution
The practical grace-period approach is beginning to be adopted around Europe, and has been the subject of official statements by French and Swiss authorities. It is based on an internal guidance document “unanimously agreed” by the European Commission’s Competent Authorities for Medical Devices (CAMD) group at its October meeting in Bratislava, Slovakia.
This guidance suggests that the authorities responsible for market surveillance may grant affected manufacturers a certain period (called the “period of grace” (PoG) in Europe), during which the marketing of safe and effective medical devices affected by the withdrawal of the designation will be tolerated and the manufacturer will be given the opportunity to restore conformity with the regulatory requirements.
The nonpublic CAMD document is not legally binding, Medtech Insight understands.
The French Response
The French national agency for the safety of medicines and healthcare products (ANSM) was, it appears, the first authority to publish its procedure, describing the CAMD document as “in perfect keeping with ANSM’s position."
In so doing, it acknowledges that there is currently no European regulation that includes specific provisions concerning the consequences of a notified body's denotification on manufacturers that relied on its services. It asks affected manufacturers to contact a new notified body as soon as possible to obtain new certificates quickly.
ANSM says that marketing of these orphaned products can continue until the end of the initial period of validity of the certificates, but up to a limit of 12 months following denotification, or the effective end of activities, of the notified body. Marketing, ANSM says, may continue as long as the manufacturer has a valid CE certificate for the product at the time of its application, and a date of validity subsequent to that of the de-notification of the notified body.
The French authorities also require the manufacturer to provide:
- A list of the references for all devices and IVDs affected by the denotification or the end of operations; this list should also specify the sales volume and the EU member states where they are being marketed and/or distributed;
- A copy of the most recent version of the CE compliance certificates identifying the products covered by these certificates;
- A statement issued by the manufacturer certifying that its products continue to comply with fundamental requirements;
- Identification of the new notified body, evidence that the certification process has been initiated; and
- The anticipated date that it will be finalized.
Finally, the audit report drafted by the new notified body should be sent to ANSM as soon as possible, as well as the new certificate.
ANSM makes it clear that it will not grant an extension for the marketing of the medical devices where the manufacturers’ certificates have expired at the time of the application period, or if the validity date does not fall after the date of the notified bodies’ denotification. However, if a medical device is essential or has no existing alternative, ANSM will examine the manufacturer’s application on an individual basis. In this particular situation, the agency says, it is the manufacturer’s responsibility to provide evidence of the essential nature of the medical device.
In response to multiple requests to the Swissmedic agency, the Swiss – who are not EU members but have a Mutual Recognition Agreement with the EU in the medtech sector – have followed with an approach that is very close to the French.
And Bernhard Bichsel of Swissmedic told Medtech Insight that while he cannot speak for other authorities, “as far as I know, most authorities will act accordingly."
Swissmedic is giving manufacturers based in Switzerland a maximum of 12 months PoG following the partial or complete de-designation of their former NB to restore the legal conformity of their product.
During this period, Swissmedic says it will not take action against devices placed on the market bearing the identification number of the “old” NB provided certain conditions are met in full, and that certain documents are submitted.
Bichsel said the published procedure reflects Swissmedic’s general approach in handling those EC certificates, whether the notified body that awarded the original certificate ceased operations due to its own volition or because it had failed an assessment. “However, as for all other nonconformities,” Bichsel said, “each is treated case by case and based on our risk-based approach, which allows taking into consideration other possible risks as well, e.g. reasons for denotification.”
Swissmedic’s conditions include:
- The manufacturer must demonstrate that the process of renewing the EC certificates of the affected products has been started with a new NB; and
- That the manufacturer submits to Swissmedic within 30 days of its notified body being de-designated written confirmation that the above conditions are met in full, along with the following documents:
- A copy of the EC certificate and any associated product lists;
- The declaration of conformity for the products concerned;
- Written confirmation from the new notified body that the process for issuing a new certificate has been started;and
- The planned timeline.
Swissmedic states that it is important to realize that the 12-month period is not an official extension of the validity of an EC certificate; “It is merely a period of time granted to a manufacturer, in consideration of the proportionality principle, to eliminate the formal deficits not caused by its own fault."
At no point, it says, does Swissmedic assume the obligations and responsibilities of a notified body; indeed, it confirms that the agency reserves the right at any time to take action against manufacturers whose products do not comply with the requirements or represent a risk and to order appropriate measures.
When it comes to issuing export certificates, Swissmedic says it will issue export certificates – such as free sale certificates – for affected EC certificates on application until the end of the PoG. The export certificates will be issued with the usual period of validity and in keeping with usual practice.
Not All Of EU
“Speaking on behalf of the EU notified bodies association, director Francoise Schlemmer said that TEAM-NB is not aware of any harmonized approach.
The German authority has said that there was a "sort" of agreement, she told Medtech Insight. Schlemmer added that the French procedure is only applicable to companies with a headquarters in France. “Germany is working on a procedure for Germany, similar to the one in France, but for Germany.”
At the moment, she explained, manufacturers have to apply in each country to which they intend to ship devices and place them on their markets. One application in country will most likely only cover a single country.
“We do not believe that one member state will accept the decision of another member state,” Schlemmer said.
In the UK there is no specific "period of grace" for companies whose notified body is de-designated, the discussions with the MHRA are primarily based around using the existing transfer process for certifying new clients with no specific dispensation given. If anything the MHRA are expecting greater scrutiny in this situation as the assumption is that the previous reviews, particularly technical file reviews will not be to the required standard.”