On May 26, 2020 the Regulation (EU) 2017/745 on Medical Devices (MDR) will enter into force in all member states of the EU simultaneously. This increases the importance of clinical data and also the requirements for documentation and risk monitoring change significantly.
In general, the clinical evaluation of medical devices and the associated way in which clinical data is generated will become more important. The aim is to show that the medical device provides the announced performance, is safe and can provide proof of the positive benefit-risk ratio. The way to prove the performance and safety of the medical device is described and justified in the clinical evaluation.
In addition, Notified Bodies will need to be MDR certified in the future. As there is currently only one MDR certified office in Europe, which (to make things even more difficult) is located in the UK (BSI UK), the availability of certified Notified Bodies may represent a huge challenge after May 2020.
Some manufacturers of medical devices of risk class I are particularly affected because their products may be assigned to a higher class (risk class IIa) after the conversion to MDR. In particular, from 26 May 2020, medical devices such as physical lozenges, dermatics or nasal sprays require MDR certification (with the involvement of a Notified Body). In addition, a quality management system according to ISO 13485 will be required.
Until the MDR enters into force, the transitional arrangement that has been in place since May 2017 applies. Until then, clinical data can be generated according to the current Medical Device Directive (Council Directive 93/42 / EEC; MDD). However, some Notified Bodies have stated that they will stop conducting re-certifications according to MDD as early as autumn 2019.
In view of the above mentioned facts one thing is certain: through MDR the certification / recertification of a medical device requires a lot more effort. The limited availability of MDR-certified Notified Bodies (“bottleneck”) appears to be risky. In order to avoid this risk, it is advisable to collect clinical data in accordance with current guidelines before MDR is a practical fact, thus extending the transitional period by a further 4 years. It should be noted that no changes are to be made to the medical device whithin the extended four-year period.
By making use of specialized partners, we are in a position to provide medical device manufacturers with a complete and competent service in dealing with the requirements of the Medical Devices Directive. This would include an analysis of the available data on the medical device (gap analysis) by our partner, thus identifying possible shortcomings in the clinical data. The Gap Analysis allows informed planning of the next steps to complete the data with the focus on approval. We will also be in the position to inform you whether a a clinical trial is required to complete the clinical assessment, if necessary.
For the planning, implementation and evaluation of clinical trials (including post-market clinical follow-up studies = PMCF), proDERM is your competent partner. Depending on your needs, we carry out these studies both in a single-center and multi-center way, where external testing centers such as medical practices, hospitals and university hospitals would be included.
Our recommendation: take advantage of the possibility to collect clinical data on PMCF studies in 2019 before MDR is implemented. This would enable you to extend the CE certification of your product. In addition, these studies are not subject to approval when compliance with the requirements of § 23b MPG is given.
We are a contract research institute with a strong dermatological focus. As such, we engage in our day-to-day business with a variety of skin and mucosal issues. The transfer of this focus to medical indications complements dermatology with the topics of ophthalmology, dentistry and gynecology.
The clinical trials conducted at proDERM are supervised by our ‘Clinical Operations’ team, which – according to the above mentioned therapeutic diversity – consists of 14 physicians from a diverse range of disciplines:
As we have recently expanded the team we present to you today our specialists with their corresponding focus.
Eva Maria Axmann
The team ‘Clinical Operations’ is managed by Dr. Bente. The team supervises the studies at our locations Schenefeld and Elmshorn near Hamburg, where it is supported by our study technicians when conducting the trial. In multi-center studies, which we conduct taking into account our network of external study centers, we are responsible for the coordination, while on-site care is provided by our partners. We are happy to answer any questions you may have about the team ‘Clinical Operations’. Please send an email to:
Starting this year’s exhibition activities, in-cosmetics, taking place in Paris from 2 to 4 April, will start. At our booth N101 our BD-Team welcomes you. On site, you have the opportunity to find out about the latest developments. We are also giving away a full delegate pass to one of our proDERM Academy events this year. On Wednesday, April 3, Ms. Springmann will also be giving a talk on our new method for demonstrating the efficacy of aluminum-free antiperspirants (‘New Method for the Efficacy Assessment of Aluminium-free Antiperspirants’, April 3 in Theatre 1). You are welcome to make an appointment in advance with us. Please use the following link. Many Thanks.
From the 7th to the 8th of May we participate with a booth at the New York Suppliers Days. Gunja Springmann and Simon Grundy will gladly answer your questions. Simon will also give a lecture on the subject of ‘microbiome’, which you may want to listen to.
From the 11th to the 15th of June you can meet Bernd Brormann and Alexandra Erlach at the World Congress of Dermatology taking place in Milan.
In addition to the well-established seminars on ‘Local Tolerance’ and ‘Claims Support’, this year we are offering for the first time an intensive seminar on ‘Raman spectroscopy’. Registrations can be made on the proDERM Academy website.
May 22-24, 2019
Local tolerance is of utmost importance for all topically applied products no matter whether pharmaceutical, medical device, cosmetic or consumer product. Too often it comes into focus only when it is too late, i.e. when the consumer complains about intolerance reactions. In order to avoid negative product experiences, manufacturers must make sure that their product in question is safe. This seminar was created to answer the most important questions on the subject of local tolerance.
November 7, 2019
In cooperation with River D, we will host an exclusive seminar dedicated to the topic of Confocal Raman Microspectroscopy (CRMs). CRMs is a technology which opens new horizons for anyone engaged in skin-related research. For developers of topically applied products CRMs uplifts the benchmark with regard to in vivo skin research especially in the investigation of in vivo penetration. For marketers CRMs enlarges possibilities in claims support. For research professionals CRMs may be a diagnostoc tool in the first place.
December 2-4, 2019
Cosmetics claims legislation that came into effect in July 2013 is having a profound if not confusing effect on the industry. Many brand owners affected are still unaware of their obligations and the lengths they need to go to reach compliance. This 3 day intensive seminar brings together international recognized experts in the field of claims development, advertising and the law, to provide an in-depth overview of the fundamentals and understanding of current EU-legislation cosmetic claims requirements compliance and what the future holds.
In our whitepaper we describe in detail the advantages and applications of the Raman method. Learn more about the measurement in the depth of the skin, in which areas this is possible and have a look at further sample results.
Two studies were designed to evaluate the potential cosmetic benefit of a biomimetic, niacinamide‐containing moisturizing cream for the first time in humans.
In both studies, healthy women were randomized to use two treatments, one for the left side of the body and one for the right, from three options: the test cream, a positive control or no treatment (use of standard cleanser only). Treatments were applied twice daily for 4 weeks to the face and forearms (Study 1) or the face only (Study 2). Instrumental and clinical skin assessments were performed by trained technicians. Study 1 involved tape stripping and a 5‐day no‐treatment (‘regression’) period at the end of the 4 weeks. Independent lay graders were asked to grade the skin texture of subjects in Study 2 from high‐resolution photographs.
The scope of this study was to utilize confocal Raman spectroscopy in the evaluation of the degree of non‐penetration into the viable skin layers of a paraffin and petrolatum‐based product for use in the intimate areas of the skin. The formulation was purposely designed with properties to prevent undesirable skin penetration.