Managing Harmonised Standards for EU MDR/IVDR Compliance

Since the European Union (EU) launched its Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR), there are fewer harmonised standards medical device companies can leverage to achieve and maintain compliance with these regulations. This article addresses the current status of harmonised standards under EU MDR/IVDR and provides tips for dealing with the challenges of meeting the compliance requirements.

One of the goals the EU set for its harmonised standards was to create a single market and establish a policy to ensure there is equality between complementary products and services. Harmonised standards for medical devices are an effort to meet this policy. These standards include requirements and/or recommendations applied to products, systems, processes, or services that are similar to those of other globally recognised standards organisations, including:

• The International Electrotechnical Commission (IEC).
• The International Organization for Standardization (ISO).

The standards set up by the EU 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).

What Is a Harmonised Standard?

A harmonised standard is a European compliance standard developed by a recognized European Standards Organisation (ESO) based on a request from the European Commission (EC) to provide solutions for compliance with legal requirements. Official ESOs include:

• CEN (European Committee for Normalisation).
• CENELEC (European Committee for Electrotechnical Standardisation).
• ETSI (European Telecommunications Standards Institute).¹

The EC maintains that using the harmonised standards for medical devices to comply with the EU MDR is voluntary. Companies are free to choose other methods to demonstrate compliance with the General Safety and Performance Requirements (GSPR) of the new EU MDR/IVDR regulations. Still, in the “Guidance on Standardisation for Medical Devices,” published in April 2021, the Medical Device Coordination Group (MDCG) explains how harmonised standards “make easier, quicker, and less burdensome the processes related to conformity assessment procedures, affixing of the Conformite Europeenne (CE) marking, and placing on the market.”²

Status of Harmonisation With EU MDR/IVDR

With the roll out of the EU MDR and IVDR, an increasing number of established harmonised standards suddenly became outdated. For example, for the document ISO 10993-1 (biological evaluation of medical devices), the EC accepts the 2009 version as harmonised, whereas the current version of the standard was published in 2018.³

As of June 2020, the total number of standards harmonised under the Medical Devices Directive 93/42/EC (MDD) is 264, but there are only 63 standards that are harmonised for the EU MDR.⁴

Below are a few examples (including the current publish dates) of standards identified for harmonisation under the EU MDR/IVDR:

• EN 556-1:2001 for medical device sterilization – Currently EN 556-1:2001+AC:2006 for MDR.
• EN ISO 10993-1:2009 for biological evaluation of medical devices – Currently EN ISO 10993-1:2018 for MDR.
• EN ISO 11135-1:2007 for sterilization of medical devices using ethylene oxide – Currently EN ISO 11135:2014 for MDR.
• EN ISO 13485:2016 for medical device quality management – Currently EN ISO 13485:2016+AC:2018 for MDR.

You can access a full list of the affected standards in the Implementing Decision M/565 document.⁵

Leveraging Harmonisation to Comply With EU MDR/IVDR

The circumstances surrounding harmonised standards for medical devices and MDR/IVDR are complex. The small number of harmonised 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:

Use appropriate international and European consensus standards as alternates.

Consensus standards such as ISO, IEC, or EN along with the EU MDR/IVDR regulations require devices to meet the state-of-the-art regulation. Essentially, this regulation requires companies 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.⁵

The International Medical Device Regulators Forum (IMDRF) defines state-of-the-art medical devices as those in a “developed stage of current technical capability and/or accepted clinical practice in regard to products, processes, and patient management, based on the relevant consolidated findings of science, technology, and experience.”⁶

Communicate with your Notified Body.

As regulations continue to evolve, Notified Bodies (NBs) 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 NB. It’s also helpful to follow your NB’s other forms of communication, which might include a blog or newsletter and messages on its website. If the organisation offers webinars or other training courses, take advantage of those sources to gain as much information as you can to progress through the compliance processes.

Given that NBs have heavy workloads, it’s important to be prepared and willing to adapt as necessary when working with the organisation. Here are a few tips on preparation:

• NBs will not rely on historic product performance or reviews; you need to have current data.
• You need to have immediate access to up-to-date documentation from clinical studies.
• The certification time frame is tight, which means there is little to no margin of error and no do-overs in pursuing regulatory compliance.

Verify harmonised standards.

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 harmonised standards will carry over to the MDR/IVDR. It’s important to verify that specific standards have or will be harmonised. If there is any doubt, you can consult with your NB.

Frequently visit informational sources and websites.

There are various websites and other sources of information to help you stay current on the EU MDR/IVDR regulations as well as see what changes are coming. The following are just a few of these sources:

• European Commission.
• ISO.
• MDCG Guidance on Standardisation for Medical Devices.
• EUMDR.
• IMDRF.

Evaluate your core quality system processes.

The regulatory requirements under EU 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. Modernising your quality management system (QMS) and quality processes gives you the confidence to sufficiently prepare for and achieve compliance with the requirements of both regulations.

References:

1. "Harmonized and State-of-the-Art Standards1. “Harmonized and State-of-the-Art Standards,” Jerome Randall, LinkedIn, Jan. 29, 2021.
2. "Guidance on Standardisation for Medical Devices," Medical Device Coordination Group (MDCG) document, April 2021.
3. "ISO 10993-1:2018” Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," International Organization for Standardization (ISO).
4. "European Commission Issues Decision on Harmonized Standards for MDR, IVDR," Ronald, Coumans, Emergo, June 16, 2020.
5. "Use of International Generally Acknowledged State-of-the-Art Standards in the Absence of Harmonised Standards Under the IVDR and MDR," Position Paper, MedTech Europe.
6. "State-of-the-Art: Unpacking MDR’s Evolving Requirements," Elisabeth Liljensten, Lina Burman, et al, MedTech Intelligence, July 27, 2022.