EMERGO SUMMARY OF KEY POINTS

• Requirements for demonstrating state of the art under MEDDEV 2.7/1 Rev. 4 are more specific than those in the current Medical Devices Directive (MDD)
• The MEDDEV is not legally binding
• TÜV SÜD has decided to extend implementation of MEDDEV 2.7/1 Rev. 4 until the date of application of the Medical Devices Regulation. Until then following Rev. 3 is deemed sufficient.

This post was updated on August 22, 2017.

Major European Notified Body TÜV SÜD has extended its implementation timeline for medical device state-of-the-art clinical evaluation requirements under MEDDEV 2.7/1 Rev. 4 to allow manufacturers more time to ensure compliance.

The TÜV SÜD decision follows the introduction in June 2016 of MEDDEV 2.7/1 Rev. 4 on Clinical Evaluations, which increased requirements on data quality for medical device clinical evaluations. This was introduced to boost the quality of clinical evaluation reports (CERs) and prepare the industry for the introduction of the Medical Devices Regulation 2017/745, which has entered into power but is not yet applicable. MEDDEV 2.7/1 Rev. 4 has made many manufacturers aware that their clinical data may not be sufficient to demonstrate compliance.

More time needed to meet clinical evidence requirements

Notified Bodies have begun requiring reference to MEDDEV 2.7/1 Rev. 4 starting in January 2017. For many manufacturers this came too soon as they were not able to produce clinical evidence according to this MEDDEV. However, as section 2 of the MEDDEV states, “This guide is not legally binding.” This means that a Notified Body cannot state non-compliance based on the single fact that the newest MEDDEV had not been followed. Cases where Notified Bodies have been too rigorous should be brought to the attention of the European Commission so that authorities may take appropriate measures.

Requirements not specified in the MDD

The MDD requires performing a clinical evaluation, but how this should be done is not described in detail. MEDDEV 2.7/1 intends to provide guidance to manufacturers and notified bodies about how a proper Clinical Evaluation Report should be drafted.  Through Rev. 3 this guidance stayed close to the Directive. However, Revision 4 has introduced some concepts that are now seen in the MDR.

Aligning MEDDEV state of the art, MDR deadlines

This difference between the MEDDEV and the current MDD has made TÜV SÜD decide to extend the implementation timeline for requiring MEDDEV 2.7/1 Rev. 4 for clinical evaluations. Until the Medical Devices Regulation applies, on 26 May 2020, manufacturers can still rely on Rev. 3, but they must have a plan for the clinical evaluation according to Rev. 4 (or of a similar level) for their devices.  After 26 May 2020, Rev. 4 will be required for submissions.

Emergo is not aware whether other Notified Bodies are also following this line.

Related European medical device regulatory resources from Emergo:

• European CE Marking consulting services for medical device companies
• MEDDEV 2.7/1 Rev. 4 and Clinical Evaluation Report (CER) compliance support
• European Medical Devices Regulation 2017/745 gap assessment and CE transition support
• White paper: European MDR 2017/745 transition timelines and strategies