The new requirements present challenges but also opportunities for the medical technology industry.

With the soon anticipated publication of the future regulatory requirements for medical devices in the form of the Medical Device Regulation, it is time for companies in the medical technology industry to plan their secure transition from the old paradigm to the new paradigm.

The regulation, which is expected to be published in the Official Journal of the European Union spring 2017, replaces the Council’s Directive 93/42/EEC of 14 June 1993 and Directive 90/385/EEC of 20 June 1990 concerning respectively medical devices and active implantable medical devices. Among the most important incentives for updating, is the wish to increase the safety of medical equipment, which improves the conditions for the free movement of the equipment within the Single Market and improves innovation and competitiveness in the European medical technology industry. At the same time, this is a general modernisation of the 23-year-old framework, which has been modified five times since it came into existence.

Thus, the preliminary consolidated formulation of the regulation that was voted on 13 June 2016, contains a number of mechanisms for streamlining the administration of the regulatory system, protection of patients’ and users’ safety, appointing and monitoring the notified bodies and the process for conformity assessments of manufacturers and notified bodies. While the technical requirements to the actual products have not changed, the requirements have been tightened, especially for clinical evaluations, and the requirements for risk management have been integrated directly into the regulation. One of the changes in the new requirements, is an increased focus on compliance management throughout the entire product’s lifecycle, rather than preparing the technical documentation, which leads to CE marking.

In the following section, some of the most important factors are described, as stated in the preliminary text.  As a player within the role of development, production, distribution and marketing of medical equipment, you should take these factors into account to ensure that already now, you are ready to meet the new requirements when they enter into force.

Changes in scope and definitions

The scope of the regulation is expanded to include a group of products without an intended medical purpose.  These specific products are listed in Annex XV. The list includes different products, such as contact lenses and high-intensity electromagnetic radiation for skin treatment. The seven identified product groups are treated the same way as other medical equipment, but the lack of a medical purpose can make for example, the risk-benefit analysis difficult.

Similarly, the term “medical device” has been re-defined on several parameters. For example, the medical purpose of prediction and prognosis in relation to disease is included. The regulation states explicit that products for cleaning, disinfection and sterilisation of medical equipment must be considered medical equipment in the future.

In general, the total number of definitions has increased from 14 to 50, since the terms from the guidelines and similar documents are directly incorporated in the regulation. These ‘new’ definitions can increase the possibility for precise interpretation of the requirements, but will probably also give rise to a number of questions, when the details for specific products must be clarified.

Elaboration of roles and responsibility

One of the most important initiatives is the elaboration of roles and responsibility between the manufacturers, manufacturers’ representatives in the EU, and importers and distributors of medical equipment.

The manufacturer, manufacturer’s representative and importers must be registered in Eudamed, which is the public accessible electronic database, which is established and controlled by the EU Commission. This is to ensure that supervisory authorities can carry out market inspections with greater efficiency than previously.

Something that is new is that the regulation now includes an explicit requirement for the establishment, execution and maintenance of a system for risk management and the detailed requirements for the system are stated in Section 1a, Annex I.

Furthermore, it is now required that all manufacturers of medical equipment implement, execute and maintain a quality assurance system, where previously this was only required when you followed the approval paths stated in Annex II, V or VI of the directive.

In addition, the manufacturer must continue to carry out clinical evaluations, including clinical follow-up after placing the product on the market, devising and updating the technical documentation on an ongoing basis, which enables an evaluation of the product’s compliance with the regulation’s requirements, design a declaration of conformity and the CE mark of the product.

The manufacturer of medical equipment, who is not established in the EU, must designate an authorised representative located in EU, as also required in the present Directive, and this designation must be described in a mandate. The representative must ensure that the compliance and its technical documentation is available. In addition, the representative must store a copy of both the declaration of conformity and the technical documentation, including any certificates from a Notified Body.

Importers of medical equipment are obligated to ensure that the products are CE marked, that a declaration of conformity is available, that the manufacturer is identified, that the manufacturer has designated an authorised representative, that the requirements for marking are followed, and that the product is handled in accordance with the manufacturer’s instructions when the product is under the responsibility of the importer.

Similarly, the distributor of medical equipment must ensure that the products are CE marked, that a declaration of conformity is available, that the relevant product information follows the product, and that any importer has complied with the requirements for this.

Thus, the players involved in placing the medical equipment on the market in EU, shall to a greater degree take responsibility for the products complying with the requirements, which ideally should help ensure that all the products are well documented and safe for the patients and for the users. This, together with the more stringent requirements for quality assurance systems and systems for risk management, can help increase the quality requirements for the products on the market to an acceptable level, which can be an opportunity for Danish and EU-based manufacturers to increase competition, since focus is no longer on price only.

Competency requirements for the person responsible for regulatory compliance

Something that is completely new is that the regulation defines the competency requirements for the person who is responsible for regulatory compliance. The manufacturers and their representatives, must have at least one person in their organisation with the required expertise within medical equipment. The requirement (simplified) is for a university graduate with at least one year of professional experience in RA or QA within medical equipment, or alternatively four years of professional experience in RA or QA within medical equipment.

Micro companies and small companies with less than 50 employees and an annual turnover of max. EUR 10 million, are not required to have the person employed fulltime within their organisation but must have such a person available on a permanent and continuous basis. In other words, the role can be outsourced but must be well described and well documented. Similarly, the role can be shared between several people, so that there is a shared responsibility, but their areas of responsibility must be documented in writing.

Electronic registration

The EU Commission is establishing an electronic database, so that among other things, it will be possible for the public to be duly informed about the medical equipment placed on the market and the associated certificates issued by Notified Bodies and the relevant players.

The database is called Eudamed and includes: Unique Device Identification (UDI) registration, registration of manufacturers, the manufacturers’ representatives and importers of medical equipment, registration of Notified Bodies and the certificates they issue, registration of clinical studies, registration of “vigilance” and ”post-market surveillance” systems and market inspections.

The registration in a public accessible database, and the increased transparency it leads to should ideally increase the safety of the medical equipment on the market and the market conditions on the Single Market.

Increased requirements for Notified Bodies

The requirements are made more stringent for Notified Bodies, through both more stringent requirements for their competencies and quality assurance systems, but their supervision has also been made more stringent. There has been increased focus on and inspection of Notified Bodies since 2013. This has resulted in their numbers decreasing from around 72 to less than 60

For the medical technology industry, this means that there are fewer Notified Bodies to choose from, they have longer waiting lists, and they are expected to change their role from being medical technology industry partners to being more police-like extensions of the supervisor authorities in relation to market inspection. But on the positive side, as a manufacturer, you can to a greater degree, expect that the Notified Bodies have the correct competencies within their designated areas, while at the same time you can perhaps to a greater degree trust the issued certificates.

A significant thing that you should already now pay attention to, is which designated scope your Notified Body expects to get under the regulation. It requires a major effort to change a Notified Body, so if it is required, it is a good idea to already plan for this now.

Classification of medical equipment

The classification rules are also being changed to some degree, but especially with the changes in the scope of the regulation and the new definitions, there can be significant changes for specific products.

Completely explicitly, the classification of software for decision support and monitoring is increased from Class I to Class IIa, and a new class is introduced, Class Ir, for reusable surgical instruments.

Clinical evaluation

The requirements for clinical evaluation of medical equipment have been tightened on several fronts. For example, clinical studies must be registered through the Eudamed database, which generates a unique ID number for each study. Similarly, for studies that shall be carried out in several member states, a coordinated procedure is introduced for application for and execution of clinical studies. The manufacturers of Class III products and implants must submit the clinical evaluation report to the Notified Body, which uploads it to the Eudamed database. A requirement for preparing a “periodic safety update report” is also being introduced. This must be updated annually for Class IIb and III equipment, and every second year for Class IIa equipment. The report summarises the results and conclusions of the collected post-market surveillance data, etc.

Recommendation for the medical technology industry

There is no doubt that the requirements in the coming regulation will present the medical technology industry with a number of challenges of both a technical and administrative nature. But for those companies that take up the challenge, there is also a number of opportunities for ensuring innovation and competitiveness. The need for well-functioning, safe and innovative medical equipment is increasing. This, coupled with the new requirements, makes it possible to differentiate and position yourself in the market. While the requirements are not yet completely formulated and the authorities, Notified Bodies and companies must adapt to the new reality, then companies must ensure that they have the correct competencies and the correct partners, and that they begin early on planning the readjustment, so that they can avoid surprises and avoid falling behind the competition. The recommendation from DELTA (from 2017 a part of FORCE Technology) to the medical technology industry, is that you should get started now and carry out general specifications analyses and draw up action plans.


For more information contact Head of Department Jakob Steensen, tel. +45 43 25 16 41.