The EU MDR – 26 May 2012 – 2017 – 2021
The EU-wide Medical Device Regulation (MDR) was originally intended to ensure greater transparency and safety when placing medical devices on the market. Despite this intention, it has been criticised by manufacturers and industry representatives since its introduction. The requirements and the bureaucratic burden appear to be too high. What is preventing satisfactory implementation and where are the failings of legislators, manufacturers and third parties? The following article takes a critical look at the regulation and identifies weaknesses in its implementation 12 years after the first draft, 8 years after it came into force and four years after it came into force.
The wind in medical technology before 2017
In 2025, the European Medical Device Regulation (EU) 2017/745 (MDR) appears to many manufacturers to be a confusing set of rules with no recognisable benefits. However, looking back at the years 2010 to 2012, this view is put into perspective. The scandal surrounding the defective breast implants from French manufacturer Poly Implant Prothèse (PIP) in April 2010 led to a massive loss of trust. This resulted in the introduction of the Dalli Immediate Action Plan in 2012, which aimed to tighten the monitoring of manufacturers and certification bodies to improve the quality of testing.
In October 2012, a team of British journalists uncovered that a non-existent metal-on-metal hip prosthesis had been approved by several notified bodies. These incidents led to the European Commission issuing new regulations on the designation and monitoring of notified bodies by June 2014, which then even led to the withdrawal of notifications.
The Commission had already been working on a reform before the PIP scandal, but the events strengthened the calls for more patient safety through stricter authorisation principles, similar to those in the pharmaceutical industry or at the US FDA. In 2013 and 2014, the first draft of the MDR was discussed in the European Parliament and finally adopted. The focus was on safety, transparency and monitoring, with responsibility for conformity assessment remaining with the manufacturers. Market entry should be possible without regulatory intervention, which is a significant difference to the authorisation procedures outside Europe, even if some manufacturers perceive this differently, especially during the transition from MDD/AIMD to MDR.
Failures by manufacturers and lobby organisations?
The MDR brings with it undeniable challenges. Although reviews by notified bodies have increased significantly, many manufacturers have still not sufficiently fulfilled their responsibilities eight years after the regulation came into force. Awareness of legal obligations was often poor, especially for Class I devices, where clinical evaluations were rarely requested for inspection by authorities. As a result, many manufacturers did not prepare corresponding assessments. As another example, the risk management of Class IIa devices was often not regularly updated as there was no inspection by the notified bodies. Not asked, not deemed necessary, not documented.
As a result, since May 2021, companies have not only been faced with the task of fulfilling the requirements of the MDR, but must also close gaps from the old MDD era. The MDR does not allow for any misunderstandings regarding the required documentation, whereby a large part of the content now defined has already been required since 1993 as part of MDD 93/42 EEC.
This becomes particularly evident in case of surveillance audits according to MDD, but under a new notified body or during the stage 1 and stage 2 MDR audits, where significant gaps are now being uncovered in the areas of process validation, clinical data and development documentation. Former private label manufacturers (PLM) who relied on the certification documents of their OEMs are particularly affected. By pointing out the relevant contents of technical documentation in Annex II and III of the MDR and thus also the required documentation within the quality management system, contents such as manufacturing documentation, development files and process validations are now specifically requested by the notified bodies – whether in the audit or during the file review.
Manufacturers should therefore honestly question their expectations as consumers regarding the safety and functionality of products that are also subject to the conformity assessment principle: namely that responsibility remains primarily with the manufacturer. Apart from medical devices, this question also applies to machines, toys and fireworks and, in future, artificial intelligence. A considered approach to these expectations can help to improve your own quality management systems and provide the required evidence in good time.
Shortcomings in the MDR
The MDR presents undeniable challenges that need to be discussed objectively, especially in terms of its added value. One aspect that is often overlooked is the language versions of the MDR. Although all versions are considered equivalent, the English version probably best reflects the original intentions. This leads to inconsistencies, especially in key terms such as “intended purpose”, which are crucial for compliance with the regulation (see Table 1). In contrast to the clear definition in the In Vitro Diagnostics Regulation (IVDR), this level of detail is missing in the MDR, which leads to misunderstandings.
Another problem is that many of the MDCG’s guidelines, which are not binding but must also be taken into account as the state of the art, are only available in English. Manufacturers whose native language is not English risk developing different interpretations, which can lead to divergent requirements. Clarifying contact with notified bodies is often limited as they are not allowed to act in an advisory capacity, which makes it more difficult to specify requirements.
For example, the MDR requires extensive clinical data that often goes beyond what would be necessary for a realistic risk assessment. These requirements can be prohibitive, especially for small and medium-sized enterprises (SMEs). Vague requirements lead to endless iteration loops with the notified bodies without any clear benefit for patient safety being recognisable. As a result, innovation is inhibited while costs increase without improved protection being guaranteed.
The requirements for documentation and processes are often not directly addressed in the articles of the MDR, but hidden in the annexes, which reduces transparency. In particular, manufacturers’ obligation to inform notified bodies of changes to the product or QMS (Annex VII, section 4.9) is often not sufficiently recognised, which leads to problems in the audit process.
In addition, experience from recent months shows that some auditors have not adapted their approach despite the MDR. As a result, critical issues only come up in the review of technical documentation, where important aspects such as supplier management and process validation are often not given sufficient consideration.
Confidence restored? Treatment successfully completed?
Eight years after the MDR was passed and four years after it has become fully applicable, the picture is mixed. The desired restoration of trust in medical technology is being thwarted by negative reporting from some associations and manufacturers. Supply bottlenecks caused by lengthy assessments are exacerbating the situation and creating a negative mood. While a risk-based approach on the part of notified bodies would be desirable, manufacturers are faced with an enormous burden of proof and documentation, which ultimately also increases costs for the healthcare system and EU citizens.
Strict reviewing by notified bodies can close gaps in conformity assessment, but often leads to endless review loops with no real added value for patients. Some medical devices will actually disappear from the market as a result of the critical review, possibly to the regret of users and patients. However, for some of these products (not all!) it can be said that this is in the interests of patients, as the products were already non-compliant under MDD and their safety and performance was never actually documented and proven. However, as these products are now classified higher, for example, and are therefore tested more closely (or for the first time) by a notified body, these gaps become apparent and the manufacturers are unable to establish the necessary evidence.
It will only become clear in the long term whether the increased costs for products that are manufactured and documented in Europe will lead to a shift to non-European countries. Scientific organisations such as the AMWF also see an urgent need for action in the area of clinical data collection in order to maintain Germany as a research location.
In principle, the legislator does not differentiate between the requirements for medical devices in terms of product and documentation origin – in other words, they are just as high for European and non-European manufacturers. In actual practice, however, it can be questioned whether the auditors and technical documentation reviewers used by notified bodies outside Europe always enforce the same high standards as those based in the EU. This question is based on experience made as consultants in the context of MDR certification. It is also to be hoped that the competent authorities will scrutinise EU representatives with the same rigour in the areas of reprocessing and electrical safety as they do, for example, for resident Class I manufacturers. Only if there is fair and comparable monitoring here will it be possible to avert long-term negative effects for manufacturers and innovation & research in Europe compared to non-European manufacturers and research initiatives and achieve the set goal: to provide safe and high-performance products for patients in Europe – at a fair price and preferably from the European value chain, including manufacturing.
This responsibility lies with manufacturers, economic operators, notified bodies and authorities.
A long version of this article was published in the mt Medizintechnik issue 01.2025.
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