Navigating the tricky waters of regulation can be frustrating and challenging for any medical device manufacturer. When those regulations change, the prospect becomes even more daunting. This post breaks down the regulatory path for medical device submissions in the European Union (EU) and explains the hurdles manufacturers may encounter.
In May 2021, the European Union belatedly implemented its Medical Device Regulation (MDR) path for medical devices after being delayed a year due to the pandemic. But nearly a year later, expectations associated with MDR are still unclear.
Challenges in the EU Regulatory System
Manufacturers Face a Mountain of Work
Manufacturers need to ensure their products comply with EU health, safety and environmental regulations. They must work with notified bodies to perform conformity assessments, create technical files, write EU declarations of conformity when necessary and ensure CE marks accompany their products. It takes a large team of experts to bring a device to market in the EU. Still, manufacturers are ultimately held wholly accountable for the accuracy of the technical file and the device’s compliance with safety guidelines.
Notified Bodies are Struggling to Keep Up
The 28 notified bodies operating in the EU struggle to keep up with demand, resulting in significant backlogs for manufacturers. Many of these notified bodies operate with limited scope, fewer resources, and conflicting information about regulatory requirements. Many have stopped accepting MDR applications for specific categories of devices altogether.
Switching to the New Regulatory Route is Difficult
Attaining MDR certification for devices approved under the previous Medical Device Directive (MDD) is also complicated. If a device was approved under MDD and it is currently in market, the CE mark remains valid. If a notified body reviews a new product and confirms that the product is compliant with current EU specifications (i.e., MDR), the manufacturer may add the CE mark.
The entire process can take a long time—up to a year with potentially six months added on to attain the CE mark. That timeline assumes that all documentation is prepared perfectly and the safety data are acceptable. When existing chemistry and biocompatibility data are not compliant with current accepted standards, additional time is required to address the data gaps. The amount of time will depend on which biocompatibility endpoints need to be addressed.
Confusion in European Countries
Since Brexit, the United Kingdom has chosen its regulatory requirements for medical devices. Instead, the country does not use a CE mark but a CA (conformity assessment) mark. A product with a CE mark can go on the UK market until June 2023, assuming the manufacturer can write a declaration of conformity. Northern Ireland is even more complex. As part of the UK but sharing a land border with the Republic of Ireland, Northern Irish notified bodies can certify EU devices, but the certificates issued are only valid in Northern Ireland.
Switzerland is also challenging. The Swiss failed to reach a mutual recognition agreement with the EU before the MDR’s implementation in May 2021. This means existing Swiss certificates of conformity and certificates issued in the EU for Swiss devices are invalid.
All these challenges mean device manufacturers need to treat the MDR certification process as though they are starting from the beginning. Even if they once held MDD certification, they cannot expect preferential treatment and may be asked to prove well-known or scientific principles about their devices. They must also fully understand how MDR applies to their product specifically.
Risk Management Requirements
Anyone planning on selling a medical device in the EU must address “physical and/or chemical information” as outlined by the ISO 10993-1:2018 standard. This is often achieved through chemical characterization data that complies with ISO 10993-18:2020. The standard has not been harmonized across all EU countries, but MDR considers it “state of the art,” as it is the most recent published version of an accepted standard.
ISO 10993-18:2020 is deemed particularly strict because of the analytical evaluation threshold (AET) and the emphasis on exaggerated and exhaustive extractions. The AET is a threshold for chemicals that requires chemists to identify and quantify compounds at or above a specific concentration to ensure all compounds of potential toxicological concern are reported for subsequent evaluation in the toxicological risk assessment (TRA).
Knowing Who Does What
Journeying through the EU regulatory pathway means dealing with many local, national and continental organizations and individuals. Knowing who is responsible for which part of the process is critical for regulatory success.
- European Authorized Representative: When a medical device manufacturer does not have a registered place of business in the EU, it must appoint an “EU Rep” to liaise between themselves and the competent authority.
- Harmonized Standard Consultant: HAS Consultants work with manufacturers to clarify a device’s legal definition and determine the best category for it.
- Notified Body: The notified body must review and approve a medical device before receiving market approval. They are independent organizations designated by EU member states to ensure devices adhere to MDR regulations.
- Competent Authority: These are usually government agencies within an EU member state. They monitor medical device safety after products go to market and are responsible for ensuring EU regulations become national legislation.
- European Medicines Agency: The EMA evaluates human veterinary medicine’s quality, safety, and efficacy. Competent Authorities usually regulate medical devices, but the EMA gets involved in certain circumstances.
All of this makes the emerging regulatory landscape in the EU daunting. Still, if manufacturers stay vigilant and wait out the collective uncertainty, they can gain or maintain access to a gigantic market. The rules may be demanding and complex, but an experienced laboratory testing partner can play a critical role in helping manufacturers achieve their goals.
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