The honorary sponsor of MT-Connect has released new guidance and recommendations on medical device regulations (MDR).
In assessing changes to MDR due for 2020, Forum MedTech Pharma states that safety and quality must take priority over speed.
CEO Dr Matthias Schier considers, however, that implementing changes in the form of the new MDR and IVDR poses challenges for the industry that could significantly impact on the dynamics of innovation, product range and future viability.
“In some cases, there is no discernible positive influence on patient safety, for example with regard to the re-certification of proven, existing products. In this context, if established or innovative medical products cannot overcome regulatory hurdles because of limited resources or requirements that are difficult to fulfil, and as a result are not available to provide optimum patient care, this does not tally with the collective goal of ensuring the best possible healthcare.” Schier said.
The paper identifies extremely short transitional periods as an example of difficult challenges. The increase in the scope of requirements for clinical assessment, technical documentation and market observation means that bottlenecks can be expected in terms of finance, time and human resources. This could result is major burdens for small and medium-sized enterprises (SMEs) since these companies do not have the financial and HR flexibility to make major advance outlays at short notice.
The group also criticises the cost of re-certification for existing products, stating they will be si high that distributors will find themselves constrained to remove established products with an important role to play in healthcare from the market altogether.
A larger number of prodcuts requiring clinical studies could also lead to bottlenecks in hospitals that lack the necessary infrastructure for medical technology studies, the group states.
The majority of members in Forum MedTech Pharma are in favour of modifying the MDR and its conditions of implementation to make it a more innovation-friendly and practicable regulation that truly encourages the best possible healthcare for the benefit of the patients.
Forum MedTech Pharma is also calling for the National Working Group for Implementing the MDR/IVDR, to ensure that the implementation or creation of legislative acts for implementation does not cause the rules to be tightened further, but that efforts will be made instead to relax requirements in terms of transitional periods, for example, within the available room to manoeuvre.
The group is also in favour of accompanying measures to support the industry in any new challenges MDR creates. Specific options could include neutral public advisory offices and centres of competence; digital platforms to gather and analyse data (e.g. mandatory registers); expanded material on Regulatory Affairs in training and professional development courses or in targeted courses of study; expanding the infrastructure in the area of clinical studies; and incentives for hospitals, patients and doctors to take part in clinical studies.