MEDDEV 2.12-2 rev.2
The guidance on Post Market Clinical Follow-Up (PMCF) studies (MEDDEV 2.12-2 rev.2) provides much improved guidance to manufacturers and Notified Bodies in replacing MEDDEV 2.12-2 Clinical Evaluation - Post Market Clinical Follow-Up dated May 2004 and implementing section 1.1.c of Annex X of the Medical Device Directive (MDD).
The new document follows the GHTF guidance and adds details on EU legislation. The guidance emphasizes the increased need for PMCF studies to be considered in drafting the risk-based PMS plans given the revised focus on clinical data introduced by 2007/47/EC revision of the MDD and AIMD directives. It clearly references the recently issued ISO 14155:2011 as basis for clinical studies and provides details on the evaluation of PMCF by Notified Bodies. More general guidance on PMCF and its relation to legislation and interaction and cooperation with registries will be provided in subsequent guidance that will be drafted. Attempts are ongoing to better embed PMCF and PMS planning into the future legislative framework in EU.
A new guideline has been established for Authorized Representatives (MEDDEV 2.5/10), which also requires the prior approval of joint EU authorities (CAMD). The document discusses the role and designation by the manufacturer of the Authorized Representative. It details registration requirements and possible elements to be covered in the Authorized Representative Contract. If the manufacturer is not enabling the Authorized Representative to follow legal requirements, they can terminate the contract. A large section deals with the interactions between the Representative and the Competent Authorities. In addition it specifies the element the Notified Body should reflect on during conformity assessments.
MEDDEV 2.2/4 IVF ART
A new guideline on IVF ART (MEDDEV 2.2/4), also based on earlier CAMD documentation, was introduced. The guideline concerns media, substances, or mixture of substances used during IVF and ART procedures which fall under the MDD with the exception of objects such as receptacles, petri dishes, pipettes or syringes. It provides the basis for hazard and risk assessment, and focuses on the elements that need to be in place for CE Marking. It discusses elements such as toxic and carcinogenic additives, drug and human derivatives added, clinical studies, Notified Body essentials, sterilization and the appropriate use of clean rooms during production. Other sections detail classifications, traceability and vigilance reporting challenges.
MEDDEV 2.14/1 rev.2 and IVD’s
The guidance on Medical Device - Borderline and Classification has been updated and revised to include more detail on some essential qualification criteria and classification issues.