Lorenzo Tempesti -

With the II Corrigendum of the Regulation 2017/745, the transitional provisions of the Article 120 (point 3 and 4) of the Regulation 2017/745 (MDR) have been extended also to some class I medical devices (further details on our blog The impact of the II Corrigendum).

However, the class I medical devices are required to meet the following conditions in order to take advantages of the transitional period:

  • The device continues to comply with Directive 93/42/EEC (MDD),
  • A notified body will need to be involved under the MDR (e.g. re-usable surgical instruments or up-classified devices),
  • A valid Declaration of Conformity, according to Annex VII of the MDD, must be drawn up before 26 May 2020,
  • No significant changes to the design or intended purpose of the device after 26 May 2020,
  • The requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in Directive 93/42/EEC. This shall be in place on 26 May 2020.

The Medical Device Coordination Group (MDCG) issued a guideline (Class I Transitional provisions under Article 120 (3 and 4) – (MDR) that clarifies the information to be provided within the Declaration of Conformity of the class I medical devices and the management of the Declaration of Conformity, in order to make use of the transitional provisions.

According to the guideline, class I medical devices manufacturers shall perform a conformity assessment on whether the device is in compliance with the current MDD.

On the basis of the result of the conformity assessment, the manufacturers have to issue a Declaration of Conformity to state that a conformity assessment has been performed and that the device complies with the MDD requirements. All these steps must be performed before 26 May 2020, otherwise it will not be possible to make use of the grace period reported in the II Corrigendum of the MDR.

In order to demonstrate that the Declaration of Conformity has been lawfully issued before 26 May 2020 and no significant changes have occurred after that date, the Manufacturers must keep the Technical Documentation, that include the technical file of the device and allows the conformity assessment of the product, at disposal of the competent authorities for a period of 5 years at least, after the last batch manufactured.

Documenting on the technical file the conformity of the device to the MDD prior to 26 May 2020 is crucial as this is the only way to be included in the grace period and also because the features of the device reported in the technical file cannot be changed. In case of changes a CE mark procedure according to MDR will be required.

Regulatory Pharma Net offers regulatory support to the Medical Devices companies. Should you require more information or clarification on this topic or on medical devices quality system and regulatory affairs do not hesitate to contact us!

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