Swissmedic’s approach to handling EC certificates for medical devices

The publication “Swissmedic’s approach to handling EC certificates for medical devices” from 22 December 2016 is obsolete.

22.12.2016

Background information

The intensification of market surveillance activities for medical devices in Europe that has been ongoing since 2013 is having tangible effects. The PIP Action Plan developed by the EU made these activities more specific and stringent, which in turn led to several conformity assessment bodies (Notified Bodies) in Europe and Switzerland ceasing their involvement with the certification of medical devices. This situation affects manufacturers of medical devices.

The 55 joint assessments – i.e. international inspections of Notified Bodies (NBs) – performed so far have led to a reduction in the number of European and Swiss NBs from approximately 80 to fewer than 60. In some instances, the scope of designation of the NBs has also been restricted. This has led to approx. 3,000 EC certificates currently not being monitored by an NB. Many manufacturers are having trouble finding a new NB at short notice in order to get their products certified. This is not an easy process as, currently it may take up to one year to complete.

From a regulatory point of view, the validity of EC certificates during this transitional period has not been fully clarified. This raises the question of whether medical devices can continue to be placed on the market for the first time with affected EC certificates.

Swissmedic and its partner authorities in the other contracting states are aware of the problem and its urgency. For this reason, a harmonised European procedure has been established and ratified at the end of October in Bratislava in the presence of Swissmedic.

This foresees that: “...the authorities responsible for market surveillance may, under certain circumstances, 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 Swiss approach to handling affected EC certificates

Swissmedic has decided to follow the harmonised European procedure.

Within this period, Swissmedic will not take action against the continued placing on the market of medical devices bearing the identification number of the “old” NB provided that the following conditions are met in full:

• Product safety is ensured, i.e. the medical devices covered by the EC certificate represent no known or relevant risk.
• The essential requirements continue to be met in full.
• The manufacturer can demonstrate that the process of renewing the EC certificates of the affected products has been started with a new NB..
• The manufacturer can produce at any time an overview of the affected products/EC certificates and their current status.
  

Documents to be submitted:

The manufacturer must submit to Swissmedic within 30 days of the NB being de-designated written confirmation that the above conditions are met in full. The following documents must be sent with this confirmation:

• A copy of the EC certificate and any associated product lists
• The declaration of conformity for the products concerned
• Written confirmation from the new NB that the process for issuing a new certificate has been started
• The planned time line.

Swissmedic will send confirmation of receipt of the documents.

Important

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 does Swissmedic assume the obligations and responsibilities of an NB.

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.

Swissmedic also emphasises that the Agency is not a party to contracts under private law between NBs and manufacturers and has no influence on the product certification process. All NBs that are entitled to issue EC certificates in the medical devices sector are listed in the EC's NANDO database with their scope (MD scopes, e.g. MD 0106 for non-active instruments).

Issuing export certificates (Free Sales Certificates, FSC)

FSwissmedic will issue export 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, in keeping with usual practice.