Medical device regulation – changes to substance-based medical devices on the horizon

08/08/2016 | Dr. Guido Middeler

Dr. Guido Middeler

25 May 2016 will go down as a significant date in the history of the European healthcare industry. This was the day when the European Council, Parliament and Commission reached agreement as part of the informal trialogue negotiations on a consensus document poised to pass through the legislative procedure for a new medical device regulation (MDR) in autumn 2016. Substance-based medical devices are expressly recognised as such for the first time in the consensus document. However, plans call for assigning the vast majority of substance-based medical devices to higher risk categories, which means they will need to meet more stringent essential requirements and will find themselves subject to certain regulatory uncertainties. We have compiled the most important points.


When the European Commission published its MDR draft in September 2012, it kicked off marathon negotiations never before seen on such a scale, requiring the European Parliament and Council to coordinate several hundred amendment proposals at first within, and then between, the institutions.

The objective of the European Commission was clearly communicated from the outset: the MDR should harmonise European law governing medical devices. Its focus also extended to such matters as the availability of safe medical devices, quick market access together with balanced control mechanisms prior to and following market launch, fostering innovations as well as small and medium-sized enterprises (SMEs), and the establishment of cost-efficient structures and processes.

The institutions have now apparently had a breakthrough, and the publication of the MDR in the Official Journal of the European Union is expected in the first quarter of 2017. The extent to which the desirable objectives of the European Commission with respect to the present consensus document can actually be achieved remains to be seen in the years ahead with the implementation of the MDR.

Legal certainty for substance-based medical devices

With a view to substance-based medical devices, substantial initial success is immediately apparent: with the introduction of the new classification rule, Rule 21 − according to which medical devices that are composed of substances or combinations of substances that are to be introduced into the human body through a natural orifice or applied to the skin must be assigned to certain categories − the existence of such medical devices is unquestionably confirmed. This is noteworthy insofar that in previous years, classification as a medical device was time and again called into question by European bodies and at the national level because the respective devices were not of a concrete, but rather a substance-based nature.

From the perspective of health economics, substance-based medical devices are highly relevant. The vast majority of the devices in question concern over-the-counter treatment options for self-medication purposes, which save the public healthcare system significant expenses from diagnoses and treatments provided by physicians. The matter of self-medication has therefore been the focus of political efforts geared towards comprehensive patient care for several years.

The European Commission consequently made it clear prior to the publication of their MDR draft that the only criterion for distinguishing between (substance-based) medical devices and medicinal products is the products’ mode of action, namely the issue of whether or not the intended purpose is achieved by a pharmacological, immunological or metabolic mode of action.

However, the consensus document raises a host of product- and process-related questions that will have a direct impact on the availability of substance-based medical devices. Substantial regulatory uncertainty also stems from the present consensus document.

Product-related questions

In accordance with the aforementioned Rule 21, no substance-based medical devices in future will fall under the risk class known as Class I. This means that in future, all Class I lozenges, nasal sprays, ear drops and moisturisers currently on the market or in development will require a conformity assessment procedure, together with a notified body, for the purpose of auditing product-related aspects and the quality management system of the manufacturer.

All told, the vast majority of substance-based medical devices are expected to be subject to a higher risk classification, even though there is room for doubt about clear added value concerning patient safety with a view to those products already on the market. The inclusion, for example, of an aqueous solution that contains simethicone for treating gastrointestinal complaints in Class III based solely on the fact that the aqueous base of the medical device can be absorbed by the body seems excessive.

The concept of including certain products without a medical purpose in the scope of the MDR is entirely new. Among others, these products include dermal fillers, such as injectable hyaluronic acid for treating wrinkles.

In future, all substance-based medical devices will also need to meet more stringent essential requirements that even surpass the requirements for medicinal products in some cases.

It is also to be expected that the number of in-house clinical trials for substance-based medical devices will increase significantly as a result of the MDR’s clarification with regard to preparing clinical evaluations. This also applies specifically to products in all risk classes already on the market. As soon as (re)certification in accordance with the new MDR is sought for the first time, the notified body must assess to what extent a manufacturer is permitted to refer to comparable products when preparing the clinical evaluation. In future, the equivalence approach will be accepted only if the manufacturer is able to provide substantial evidence that the product it draws on as reference meets the necessary essential requirements per se. However, this may pose an unsolvable problem to most manufacturers.

In the end, the medical devices that stand to be hit hardest by this are all those that contain live microorganisms for achieving their intended effect, such as lactobacilli for treating vaginal ailments. This product group is excluded by definition from the scope of the MDR, regardless of its non-medicinal mode of action and its relevance as a self-treatment option for millions of women who are affected. In this case, it may be necessary to ensure the longest remaining period possible for their marketing as medical devices while simultaneously securing the marketability of the products in question as medicinal products.

Process-related questions

In addition to featuring the established requirements of EN ISO 13485, quality management systems in future will also need to have as integral components processes for clinical evaluations, the post-market follow-up system and risk management. Moreover, documented plans, implementation and evaluations must be provided for each one.

The person responsible for regulatory compliance will have a particularly important role to play, as he or she will be responsible for duties concerning product quality, vigilance and the proper implementation of the MDR in terms of products and processes.

Due to the massive reduction of the notified bodies based on the Implementing Regulation (EU) No 920/2013 on the designation and the supervision of notified bodies for medical devices and the necessary renotification of the remaining notified bodies in accordance with the requirements of the MDR, it is becoming more difficult for the companies that are affected to obtain the necessary product certificates by the time the transitional periods lapse.

Doing away with (and not replacing) the regulatory option to consider third-party conformity assessment procedures in accordance with Art. 11 (7) of the current version of Directive 93/42/EEC on medical devices calls the Original Equipment Manufacturer−Private Label Manufacturer (OEM-PLM) approach into question. This approach was inter alia used by microenterprises in particular to market their products by involving strong sales partners, though without having to reveal their entire expertise to said sales partners. One way out of this dilemma is to bring in a “responsible manufacturer” as a neutral entity between the actual OEM and its sales partners.

Regulatory questions

In future, the European Commission will be able to decide − either on its own initiative or upon request by a member state − on the classification of a given product as a medical device. Plans here call for consulting the Medical Device Coordination Group (MDCG) − a new body that must be created. The MDCG will consist of one delegate each from the member states for medical devices and in vitro diagnostic medical devices. Industry representatives will not be represented on the MDCG, however. This runs the risk that the European Commission and the MDCG will not have all of the information necessary for ensuring the consistent evaluation of a specific case when it has to decide what devices to include or exclude.

The MDR also contains a variety of references to so-called delegated acts and implementing acts that may be enacted by the European Commission once the MDR enters into force − and without re-evaluation by the European Parliament and Council. The references to delegated acts and implementing acts serve as de facto placeholders for an assumed need for regulation, which has yet to see consistent implementation proposals in the last four years. This consequently results in great uncertainty for the manufacturers, as it is not entirely foreseeable to date how the MDR is to be implemented in a compliant manner in future.

Many of the new regulatory requirements are linked to the planned European database for medical devices known as Eudamed. Plans call for using the database to centrally record data concerning medical device registration, unique device identifiers, product certificates, vigilance, market surveillance and clinical trials. These requirements are limited by the availability of a functioning database, which experts believe will be up and running only long after the transitional period provided for in the MDR has lapsed.

Capped at three years after the MDR enters into force, this period is relatively short considering that the remaining notified bodies must first obtain notification in accordance with the MDR in order to even be able to issue certificates pursuant to the MDR. At the moment, there is controversial debate about the extent to which the validity of certificates that were issued in accordance with the previous requirements of Directive 93/42/EEC on medical devices will still allow for the manufacture and marketing of new batches of the medical device in question once the transitional period has lapsed. This would be logical, as the companies are, in fact, dependent on the (re)notification of their notified body and will only be able to obtain (re)certification of their existing medical devices once the notified body has been  renotified. Paradoxically, however, this in turn results in the situation that substance-based medical devices that previously fell under Class I will be the first to have to fully meet the MDR requirements, as there are no existing certificates with defined periods for these products.


In summary, clarification of the legal existence of substance-based medical devices is a welcome development. Since the MDR adheres to the new approach − namely the free movement of goods with regard to medical devices in the European Union, provided it has been proved that they meet the essential requirements in a proper conformity assessment procedure − it remains the case that no national or central authorisations are necessary for substance-based medical devices.

On the other hand, the MDR entails a number of product- and process-related changes whose implementation will pose a challenge to manufacturers already during the transitional period. It will be crucial − particularly in the months ahead − to arrive at an appropriate interpretation of the provisions now available in consultation with lawmakers.

As part of the services provided by Diapharm, we are already helping our clients to prepare for the MDR using a targeted approach and to safeguard their medical devices. Based on its own certification in accordance with EN ISO 13485, Diapharm will even entirely take over supervision and support in this matter.

In the weeks ahead, we will also be discussing in detail various effects of the new medical device regulation on substance-based medical devices. The next topic:

  • Rule 21 and the future tightening of the fundamental requirements

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