Approval procedures for medical devices: uniform across the EU, varying nationally
In this article, we highlight the similarities and differences in the approval procedures of individual European Member States. Although the European Economic Area harmonises many requirements, the specific implementation of medical device legislation is in the hands of the national states. As is often the case in the EU, medical device law also involves a balancing act between European unity and national individuality.
Introduction – From MDD to MDR
In the European Union (EU), the Medical Device Regulation (MDR) the requirements for the approval and conformity of Medical Devices (MDs) .
This cross-border regulation is one of the EU's great achievements: until the 1990s, the regulation of medical devices in European countries was extremely inconsistent. Each country had its own requirements, approval procedures and different standards and definitions for medical devices. The Maastricht Treaty of 1993 is considered the first groundbreaking regulation towards EU-wide harmonisation. As a result, the Medical Device Directive (MDD) became valid for the then internal market of the newly founded Union.
Throughout the 1990s and 2000s, the EU grew and, at the same time, national legislation became increasingly harmonised with the MDD. However, the MDD left member states with a great deal of leeway, and the regulation of medical devices still varied greatly between countries in terms of quality and safety requirements. When the PIP scandal involving breast implants manufactured in France broke in 2012, calls for more uniform and stricter regulation grew louder.
However, legislation requires a great deal of time for deliberation, especially in the plenary chambers of Brussels, and so it was not until almost ten years later, in 2021, that the Medical Device Regulation (MDR) was adopted.
This contains much more detailed definitions regarding the classification, assessment and test of medical devices and introduces a binding, centralised EU-wide register for recording medical devices.
Nevertheless, there are also sections in the MDR where Member States are explicitly or implicitly called upon to draft their own regulations. In addition, it is lawful for Member States to issue their own regulatory requirements, provided these do not conflict with the European MDR.
Uniformity – General requirements for medical device approval in the EU
As already mentioned, the MDR represents a significantly more binding legal framework than the MDD. In the course of the European harmonisation process, it was necessary to establish some general regulations that apply in all EU Member States.
Here we briefly describe the most important of these regulations, which apply uniformly throughout the EU. It should be noted, however, that there are always exceptions and that the MDR regulations often allow room for interpretation in practice, within which national authorities can apply their own interpretation.
Product classification: According to Annex VIII of the MDR, medical devices are divided into four different risk classes: I, IIa, IIb and III. The rule of thumb is that the greater the potential harm that a product can cause if it malfunctions, is used incorrectly or causes an adverse event, the higher the risk class to which it is assigned. And the higher the risk class assigned to a product, the stricter the regulations to which it is subject.
CE label: Medical devices marketed in the EU must generally bear a CE label. The MDR specifies in detail the conditions under which a product may or must bear the CE label (e.g. via conformity assessment and technical documentation). The general legal basis for the CE label itself can be found in Regulation (EC) No 765/2008.
Conformity assessment: Annexes IX, X and XI regulate various procedures for assessing the conformity of medical devices. The conformity of a product refers to its compliance with the applicable regulatory requirements, particularly with regard to product safety and performance, i.e. clinical benefit. It is evaluated by means of a conformity assessment. Products in higher risk classes tend to undergo more stringent conformity assessments. For products in lower risk classes, manufacturers can usually perform the conformity assessment themselves, while for products in higher classes, external testing laboratories and so-called. notified bodies are consulted.
Technical documentation: Eine engmaschige Dokumentation der Entwicklung des intendierten Zwecks sowie der diversen Konformitätsprüfungen ist ebenfalls durch die MDR vorgegeben und in allen EU-Ländern für Hersteller erforderlich. Die Technische Dokumentation muss sowohl vor dem Markteintritt für die erforderlichen regulatorischen Hürden vorliegen (gesetzt durch MDR, Anhang II), als auch nach Markteintritt für die Post-Market-Surveillance bzw. Vigilanzpflicht des Herstellers, Bevollmächtigten, Importeurs oder Vermarkters geführt werden (gesetzt durch MDR, Anhang III).
Clinical evaluation and test: Whether a product meets safety and benefit requirements must be determined by means of a clinical test in accordance with the MDR and recorded in a clinical evaluation. The requirements for conducting such studies can be found in Chapter VI, Articles 61-82 of the MDR.
Duties of the Economic Operators for placing on the market: The MDR not only defines the various roles of relevant economic actors behind a marketed medical device, but also assigns them specific roles and responsibilities. These are regulated in Chapter II of the MDR:
- Manufacturers are responsible for establishing a quality management system (QMS) and must have a Person Responsible for Regulatory Compliance (PRRC) name their products and register them with a Unique Device Identifier (UDI) via the EUDAMED portal.
- The one or ones European Representative must be named when a product is imported from outside the eurozone – he or she assumes manufacturer responsibility for the regulatory compliance of the product within the eurozone before and after market entry or from the start of reimbursement eligibility.
- Importer and distributors are responsible for compliance with national law in the case of exports or imports within the European single market. For example, they translate operating instructions or register with national notified bodies. They are also responsible for checking the CE label.
UDI system: Der Unique Device Identifierist eine eindeutige Kennnummer für Medizinprodukte, die Produkte zentralisiert innerhalb der EU identifiziert und so Rückverfolgbarkeit und Rückrufbarkeit erleichtert. Eine UDI-Kennung ist gemäß Kapitel III der MDR für die gesamte EU verpflichtend.
Post-market surveillance and vigilance: Chapter VII of the MDR regulates the obligations of manufacturers, importers and distributors with regard to post-market surveillance and vigilance concerning the ongoing safety and usefulness of the product. These obligations also apply to the entire EU economic area.
Individuality – national differences
There are many differences in the regulation of medical devices in individual EU countries. We would like to provide our readers with an overview, but we still urge you to seek expert test in individual cases.
Language of product documents: The MDR requires manufacturers, importers and distributors to provide “understandable product information”. Most EU countries therefore insist that product documents such as operating instructions or package inserts be translated into the respective national language before the product can be marketed.
Registration requirement prior to market entry: In addition to the mandatory CE label, some EU countries require registration with a national authority. In France, for example, medical devices must be tested and approved by the ANSM (Agence nationale de sécurité du médicament et des produits de santé), while in Italy, an Italian importer must register the product with the Ministry of Health, and the situation is similar in Spain. Like France, Belgium also has a national regulatory authority. In Germany, registration with the DMIDS (German Medical Devices Information and Database System) is also mandatory.
Role of importers and PRRC: Country-specific registration requires various obligations and roles for economic operators. Importers and responsible persons are generally responsible for implementing national regulations for manufacturers from third countries.
Differences in supervision and sanctions: The MDR obliges Member States to introduce sanctions – the severity of these sanctions is regulated at national level. Germany, for example, imposes fines of up to €100,000, while in Austria only €50,000 is required for similar offences or negligence.
EUDAMED is one perspective so far: Registration via EUDAMED is mandatory and more and more products must be registered in this way.However, the platform is still in its infancy, and many EU countries still have their own national registers, which are unlikely to be abolished any time soon. In Germany, for example, registration in the DMIDS mentioned above is mandatory.
Scope for interpretation
In addition to the scope for interpretation that the MDR expressly leaves to national legislators, there is also room for interpretation in areas that are actually considered strictly harmonised. This is mainly due to the human factor: Different levels of training or education lead to different priorities in the assessment of product conformity; cultural differences in terms of safety awareness and compliance with regulations simplify or complicate a test; notified bodies sometimes work more strictly, sometimes less strictly. Ultimately, it is still individuals who decide on the approval of a product, and this creates room for interpretation even under the tightly knit MDR.
What Does it all Mean?
Despite the harmonisation trend in the MDR, there are still many regulatory differences within the EU. The trend of recent decades clearly points to further harmonisation within the EU, and it can be assumed that the regulatory landscape will continue to be standardised by Brussels legislators.
However, manufacturers, importers and distributors who want to bring their medical devices to market today have to deal with a patchwork of national regulations. Because this is meticulous and often tedious work, it can be very helpful to rely on external partners such as BEO BERLIN.
BEO BERLIN has over 25 years of experience in supporting manufacturers, importers and distributors on their path to regulatory compliance in the EU, the US, the UK and Switzerland.
Contact us for advice – we are happy to help!
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