Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory requirements for products used for In-vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) according to MEDDEV 2.2/4 ***

Dr. Silke Stender (Abschlußjahr: 2013)

Summary
The guideline MEDDEV 2.2/4 "Guidelines for conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products" reflects on the complex regulatory requirements to promote the efficacy / performance and safety of Medical Devices (MDs) used in ART in a consistent high quality.
This master thesis illustrates the information and references provided in MEDDEV 2.2/4 and raises and discusses further issues specific to ART. Brief information concerning the so-called Essential Requirements and Risk Assessment, on Product Development and on Quality Management Systems for MDs in general is given, because these are crucial items to ensure safe and effective MDs, also ART- and IVF-MDs. The demarcation and classification of MDs used in ART is described and some examples are provided. Reference to additional standards and guidelines to facilitate argumentation in the justification for risk assessment and fulfilment of the Essential Requirements beyond those given in the guideline is given.
Some parameters and attributes which could influence the development of gametes and embryo or have a negative effect on the mother-to-be are discussed in this paper and a benefit for the establishment of additional appropriate test methods is revealed. Access to an objective collection or evaluation on risks, appropriate actions and control methods attributable to this type of product and addition of further corresponding recommendations in the guideline would be beneficial.
MEDDEV 2.2/4 is the only guideline for MDs addressing one type of MDs based on the target (gametes, embryo and mother-to-be). The use in this target is associated with special risks, e.g. for long-term effects that may be revealed only late in development of the embryo or the child. Notification procedures laid down for tissue and cells have to be followed. It should be considered that each MD used in ART generally forms only a part of the treatment and it may be difficult to attribute adverse reactions to a certain product. Access to and use of databases may contribute to cause analysis in vigilance and surveillance to harmonise and improve quality of ART-MDs.
MEDDEV 2.2/4 in its current state could also be applied to MDs in general, especially to those in a similar presentation and those categorised in the borderline area to Medicinal Products. As there is no such guideline available yet, a change in the designation of the guideline may be an option, while retaining and expanding specific guidance to ART-MDs as part of such a guideline.
Pages: 70