The latest Medical Device Regulation (EU) 2017/745 or EU MDR was introduced to make the medical device market safer for patients and to improve the standards and transparency information of medical devices across the EU.
The new rules aim to avoid problems that come from the divergent interpretation of regulations and to stop incidents like the introduction of unsafe breast implants and metal hips to the market that represent a risk to patients.
The impact of the EU MDR regulations is huge. The medical devices sector has over 25,000 companies and employs more than 500,000 people.
Since the medical device sector is mainly driven by SMEs it was faced by concerns about the complexity and costs involved in its implementation.
However, the European Commission has reassured the industry that the regulation helps simplify administrative procedures, increase legal certainty and increase credibility and reputation of the overall system.
This will be the result of three main factors: simplified administrative procedures - under the new framework, registration of devices and operators will have to be done only once at the EU level. This is a major change compared to today's situation where in many cases manufacturers might be required to register their products in all Member States where those products are placed on the market. - increased legal certainty - growth and competitiveness build on the existence of a stable set of legal requirements. Contrary to a Directive, a Regulation is directly applicable in all Member States: this will help to avoid varying conditions for patients and industry in different countries. The new texts also include precise and detailed clarifications of the scope of the new rules, a list of clear obligations of relevant economic operators as well as an indication of the specific exemption regimes which apply to certain devices or practices such as in-house devices or reprocessing of single-use devices. - increased credibility and reputation of the overall system - industry's reputation is highly sensitive to the credibility of the EU medical device system as a whole. Various incidents as well as public reports regarding an alleged “uneven approach” among the bodies responsible for certification and approval of medical devices have damaged the confidence of patients and healthcare professionals in the safety of the devices they use every day, while confirming some weaknesses in today's legislation. The new Regulations address the shortcomings of the current legislation and aim to increase the overall confidence in the medical device market. - These advantages should counterbalance the extra costs incurred by companies due to compliance with the higher safety standards and new requirements contained in the new Regulations. Specific needs of SMEs have been addressed in the texts particularly in relation to new requirements on financial coverage for manufacturers, person responsible for regulatory compliance and fees charged by Notified Bodies. This gives a potential boost to SMEs active in this sector.