Businesses will be expected to comply with the new EU Medical Device Regulation and the EU In-vitro Diagnostics Devices Regulation passed by the European Parliament. These come into effect on 26 May 2020 and 26 May 2022 respectively.
There are a few substantial penalties involved with these new regulations, so businesses in the life sciences industry should familiarize themselves with the changes and prepare their processes in order to comply.
This blog post will help you familiarize yourself with the changes and assist you with preparations for the upcoming regulations.
Why are the regulations changing?
The reason for the revise of the regulation lies in technological changes and recent scandals that have abused the current medical device regulations, which have not been updated since the 1990s.
Most notably, ‘PIP’ breast implants and DePuy metal hip replacements have highlighted some of the shortcomings of the current medical device regulations, with the European Commission citing “the weaknesses of today’s legislation” to be the root cause of the abuses.
The Commission seeks to improve the quality, safety and reliability of medical devices, while also strengthening provider transparency in order to protect the market and consumers. These aims will help when interpreting the changes that will impact all EU suppliers of medical devices.
What are the new regulations changing?
There are quite a few changes that will impact businesses that supply medical devices. Many of these changes will now impact businesses that were previously unaffected by the regulations set in 1990 and in current use.
Here are a few points to take into consideration when preparing for the upcoming changes.
A wider set of products will be regulated than before
The definition of what a medical device or in-vitro diagnostic medical device is has been broadened to include products that were previously not regulated. Here are the major new products that will be affected.
- Medical software
- Devices previously considered accessories to traditional devices (e.g. cleaning and disinfecting products)
- Contact lenses and other products introduced in or onto the eye
- Products that surgically modify anatomy
- Substances used for dermal or other fillers
- Equipment for liposuction, lipolysis or lipoplasty
- Lasers for skin treatments such as skin resurfacing, tattoos or hair removal
- Equipment for brain stimulation
Many companies that were previously unregulated will face a significant challenge in getting up-to-spec with the new requirements.
New risk reclassification
A new Medical Device Coordination Group has been formed to introduce common specifications for medical devices and will support the European Commission in respect of implementation.
Due to this, certain devices and in-vitro medical devices will be reclassified to higher risk categories. For example, devices that contact the spinal column in any way will now be classified as the highest risk category (Class 3), and a large number of in-vitro devices from the lowest risk category will be reclassified to higher risk categories.
Companies that were previously subject to self-assessment will now require approval from external certified bodies and will have to comply with more stringent requirements. Life sciences companies are encouraged to confirm the new risk categories of the specific devices that they deal with.
Enhanced transparency and vigilance
Over the following years, changes designed to boost transparency and traceability will be phased in, starting with devices in the highest risk categories.
Each medical and in-vitro device will require a unique device identifier which will be recorded on the European database for medical devices. This is to ensure that devices have a recorded history and to help combat counterfeit devices in the event of product recalls.
Regulatory authorities will also have more right to conduct audits and unannounced visits. Each manufacturer will be audited once every five years at a minimum. These authorities will also be reassessed regularly to ensure that they are effectively monitoring and enforcing requirements.
Since audits and check-ups by authorities will be more numerous and unpredictable, companies will be expected to keep a close eye on their procedures and maintain extensive, accurate records, perhaps at the cost of additional human resources.
The current and previous regulations focused solely on manufacturers, who were responsible for the production and any complications that arose from the defects of their products. Now, for the first time, all of the actors in the medical device supply chain will have potential responsibility for any defects in the devices they deal with.
Manufacturers are also now required to have at least one person responsible for regulatory compliance within the organization or as a consultant. Additionally, all manufacturers outside of the EU will need EU-based authorized representatives in order to conduct business within the EU.
All companies should now establish vigilance procedures for the devices they deal with. Manufacturers will have to invest in specialist roles, and in the case of foreign companies, will have to accommodate and budget for an EU representative. This is especially important for companies that are affected by Brexit.
What are businesses required to do?
Businesses need to fully comply with the Medical Devices Regulations by 26 May 2020 and with the In-vitro Diagnostics Devices Regulation by 26 May 2022.
The impact of the regulations depends on the role of the business. Immediate steps which medical devices businesses should consider include:
- A product portfolio assessment. This is likely to be required anyway, and companies would be wise to see which of their product classifications and requirements will change.
- Human resources considerations. Including changes to contracts, roles and any new hires in light of the new obligations and liabilities.
- Securing budget for increased compliance costs, including bringing on board responsible persons.
By adopting a proactive approach, the new regulations will assist businesses with future compliance and help them prepare for any new processes that they may need to adopt. Through this approach, they will secure themselves from any penalties, and ensure that their products are kept to the highest standard.
EXTEDO SafetyEasy MD
EXTEDO offers a comprehensive solution for effortless medical device compliance in the form of SafetyEasy MD.
SafetyEasy MD maintains device vigilance automatically and delivers a best practice monitoring and reporting workflow designed to keep your business in spec with the latest requirements.
With SafetyEasy MD you can:
- Readily monitor device safety activities
- Stay compliant with latest medical device regulations
- Operate a single database for device vigilance data
- Use a cloud-based platform with no need for customization
- Operate efficiently and easily, with minimal training effort
If you’d like to find out more about SafetyEasy MD, visit our website, or, if you’d like to find out more about the upcoming regulations for EU medical devices, please review the official European Medicines Agency website.