Do you need an importer during the MDD/MDR transition period?

Do you need an importer during the MDD/MDR transition period?

Transitioning MDD to MDR

Until May 2025, products certified under the Directives and products certified under the Regulations may coexist on the market. Both will have equal status under the legislation.

A transition period is needed as the new Regulations require the designation of Notified Bodies. In addition, manufacturers need to meet more stringent criteria, particularly in terms of clinical and performance evaluation requirements.

The MDR is not very clear about requirements for specific transitions which causes confusion in the industry and questions manufacturers whether or not to comply with directives such as article 13 – assigning an importer of record.

Do you need an importer if you are in the transition period of the MDD to the MDR or if you have a self declared medical device?

The short answer is yes. If in the case a medical device manufacturer would have an MDR compliant product between the grace period 26 May 2021 until 26 May 2024, it would require medical device manufacturers to run 2 parallel quality management systems that should match the registration, tracking and all other requirements in the MDR. This would create confusion, administrative burden and inabilities to track the devices.

To keep the transition managable, article 123 (3) states specific requirements from the MDR would overrule the directives and would require medical device manufacturers to comply per May 26, 2021. These specific requirements are post-market surveilance, market surveillance, vigilance and the registration of economic operators.

This would mean medical device manufacturers need to comply with article 13 (obligations of the importer) and article 14 (obligations of the distributor).

Article 123 (3) is copied below:
123 / 3. By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.

Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified.

Categories
Featured Posts