1st Quarterly update 2009

Borderline issues frequently occupy our minds as an increasing number of pharmaceutical companies consider changing the regulatory status of their products from pharmaceuticals to medical devices. Not only the regulatory pathway leading to the final certification is by far the easiest for medical devices, also the requirements for proof of efficacy are less stringent. Over the years we have witnessed quite a few of such transitions and this quarter we have been involved in a similar transition for homeopathic medicines caused by the extreme tightening of regulations for these products imposed by our recent (2007) new law on medicinal products.

As a matter of fact we have been involved in medical device regulatory issues long before the birth of the EU Medical Device Directive (MMD) and this vast experience also has been useful for other clients as well. Another project this quarter was aimed at the design and development of a Class IIb medical device under the Annex II regulation of the MDD. Annex II requires the presence of proper design procedures to be followed in the course of the design proces leading to the ultimate marketing of the devices. And although this new medical device only is an extension of an existing series of devices there’s a lot of work to be done with respect to design planning, design verification, design validation, risk analysis and, finally, design transfer to manufacturing.

Even more borderline issues had to be solved for another client who wanted to integrate and harmonize the various quality systems which apply to the different types of products circulating is his facility. Having medicinal products, medical devices and food supplements present would mean that a GDP-system, a HACCP-system and the ISO 13485 system should be present to cover all the required certifications. At the same time it is not manageable to have these three systems up and running at the same time and therefore one of our colleagues will devote her time to the integration of these separate system into one multifocal quality system.

More quiescence there was in the medicinal product regulatory domain, so we could easily solve the staffing problems of three Big Pharma companies requiring temporarily support of their regulatory and/or pharmacovigilance departments during this quarter. However already some new requests from their competitors came in for similar support during the second quarter. Might not remain that quiet at all this spring……