Europe is well established and versed in the global medical device industry. However, just as all industries across all sectors, there are constant changes and aberrations to standard procedures of operation. Changes to the medical device regulations and guidance documents tend to roll around on a yearly basis – affecting organisations from powerhouse markets, such as Germany to emerging yet promising regions, such as Romania.
During my extensive research, having spoken to over 40 industry experts at director level, I was able to glean their personal thoughts and concerns regarding a range of elements within the medical device industry. Their concerns overlapped from the larger manufacturers (Boston Scientific, Johnson and Johnson and St. Jude to name a few) to smaller start-ups. The recurring theme across the industry happened to lie in the new regulatory changes made during the 4th revision of the 2.7.1 guidance document. Given that the underlying issue were the changes to regulations, it was understandable that a majority of other concerns stemmed outward from there.
New Guidance Document 2.7.1
The new guidance document has been edited by the EU Commission, with updated requirements and conditions for the industry regarding clinical evaluations. These changes affect the industry and beyond, additionally making an impact on notified bodies and CROs given their involvement in clinical studies. The revisions made by the commission are designed to provide guidelines as well as promote a common approach by all parties involved in clinical studies. The guidelines are regularly updated, in accordance to regulatory developments. It is important to note that these changes do not affect IVD (In vitro Diagnostic) devices.
Post Market Surveillance
It was made clear that many manufacturers are able to obtain the CE mark, however, the larger challenge lies in having their product be successful in the market. A lot of time, money and resources are spent to gain market approval and obtain a CE mark. So it’s extremely vital that these resources are not expended in vain, thus having an effective post market strategy to maximise market success is essential. The overlap possibility of using clinical data in order to boost the quality of the Post Market Surveillance is something which needs to be discussed. Eucomed are holding an important role in terms of the Eudamed database, which aims to provide a large accessible database for Europe (similar to that managed by the US Food and Drug Administration). This database will aim to provide a means of accessing a large pool of vital information easily and at a quicker pace to boost market access. The data made available through the database will provide a new unique point of entry for trial submissions.
Development of Outsourcing Models
In recent years, a pattern has developed within the industry where companies, across all regions, have diverged away from being dependant on functional outsourcing models to now developing more source service models. Of course, the reason behind picking a specific outsourcing model begins with analysing internal competencies and available resources. Manufacturers must begin by considering if it’s viable to build their expertise, if applicable, otherwise assess which expertise can be bought from a CRO.
Working with a single, multi-disciplinary CRO, provides a strong relationship between both parties. Nevertheless, a lot depends on the flexibility achievable with the study, and vice versa for working with multiple specialised CROs.
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An effective study relies heavily on co-operation between all members involved. While this may seem obvious, many factors are missed or neglected when relationships are formed between aforementioned parties. Ideal resolutions to reoccurring aberrations in studies would be to form a partnership, involving other respective members of the party as soon as the study begins.