Since the European Union (EU) launched its Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR), there are fewer harmonized standards that medical device companies can leverage to achieve and maintain compliance with these regulations. This article addresses the current status of harmonized standards under MDR/IVDR and provides tips for dealing with the challenges of meeting the compliance requirements.
One of the goals of the European Union was to create a single market and set up a standardization policy to ensure there is equality between complementary products and services. Harmonization is an effort to meet this standardization policy. Harmonized standards include requirements and/or recommendations in relation to products, systems, processes, or services that are similar to those of other globally recognized standards such as the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO). The standards also explain what needs to be included to meet an acceptable benchmark, such as compliance with the ISO 13485:2016 standard for a medical device Quality Management System (QMS).
The European standard (EN) was developed by a recognized European Standards Organization (ESO) based on a request from the European Commission. Official ESOs include CEN (European Committee for Normalization), CENELEC (European Committee for Electrotechnical Standardization), and ETSI (European Telecommunications Standards Institute).1
The European Commission maintains that using the harmonized standards is voluntary. Companies are free to choose other methods to demonstrate compliance with the General Safety and Performance Requirements (GSPR) of the new European regulations. Still, in the “Guidance on Standardization for Medical Devices,” published in April 2021, the Medical Device Coordination Group (MDCG) explains how harmonized standards “make easier, quicker, and less burdensome the processes related to conformity assessment procedures, affixing of the CE marking, and placing on the market.”2
With the roll out of the MDR and IVDR, an increasing number of harmonized standards are out of date. For example, for the document ISO 10993-1, the European Commission accepts the 2009 version as harmonized, whereas the current standard was published in 2018.
The total number of standards harmonized under the Medical Devices Directive 93/42/EC (MDD) is 264, but there are only a few standards that are harmonized for the MDR. Below are a few examples of standards identified for harmonization under the MDR/IVDR (a full list of affected standards may be referenced in the Implementing Decision M/565 document):3
The circumstances surrounding harmonization and MDR/IVDR are complex. The lack of harmonized standards for these regulations will create challenges for medical device companies in their efforts to comply with the new regulations. Below are tips to help manufacturers deal with these challenges:
Consensus standards such as ISO, IEC, or EN along with the MDR/IVDR regulations require devices to meet the state-of-the-art regulation. In a nutshell, companies need to design products according to what is generally accepted in the industry and in public health. The devices don’t need to be the most sophisticated technology; they just need to be consistent with the current regulatory standards.4
Notified Bodies are functioning based on their own processes, limitations, and resources. Therefore, you should expect there to be delays in reviews and approvals. But it’s important to stay in communication with your Notified Body. It’s also helpful to follow your Notified Body’s other forms of communication, which might include a blog or newsletter and messages on its website. If the organization offers webinars or other training courses, take advantage of those sources to gain as much information that you can as you progress through the compliance processes.
Given that Notified Bodies have heavy workloads, it’s important to be prepared and willing to adapt as necessary when working with your Notified Body. Here are a few tips on preparation:
Don’t assume that the relevant standards used to demonstrate conformity under the Medical Device Directive (MDD), In Vitro Device Directive (IVDD), and Active Implantable Medical Device (AIMD) lists of harmonized standards will carry over to the MDR/IVDR. It’s important to verify that specific standards have or will be harmonized. If there is any doubt, you can consult with your Notified Body.
There are various websites and other sources of information to stay current on the MDR/IVDR regulations as well as see what changes are coming. The following are just a few of these sources:
The regulatory requirements under MDR are more granular and stringent. Revisiting your quality system solutions and processes to ensure they align with the new regulations will help ensure compliance. Modernizing your quality management system (QMS) and processes gives you the confidence to sufficiently prepare for and achieve compliance with the requirements of EU MDR/IVDR.
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