For almost 25 years, the manufacture of medical devices that are marketed and sold in the EU has been regulated by the Medical Device Directive (MDD).
In 2017, the new EU Medical Device Regulation (EU MDR) was introduced, with some key changes.
Although the deadline for implementation isn’t until next year, now is the time to start preparing for full EU MDR compliance. We take a closer look at what requirements have changed and what compliance entails for manufacturers.
Who must comply with the MDR?
All medical device manufacturers who want to sell and market their equipment in the European Union will be required to comply fully with the new regulations by 26 May, 2020.
Key changes: MDR vs. MDD
EU MDR regulations are not hugely different from what we already see with MDD. Most of the new regulations are extensions of existing MDD requirements. They won’t come as a surprise to manufacturers already adhering to these regulations.
However, MDR introduces some important changes. For example:
- cosmetic devices are now covered
- each device now needs a unique identifier for tracking or recall
- companies will need to appoint a person or people to manage MDR compliance.
- manufacturers must document their risk management plan for identifying and mitigating potential hazards
- unannounced audits must test and review quality management systems (QMS) every five years at minimum
- the time frame for reporting adverse effects has been cut from 30 days to just 15
- MDR will include common specifications to provide more specific criteria when other standards or regulations aren’t sufficient
- changes to classification and clinical requirements mean that some devices will now fall under different classifications.
MDR unique device identifier (UDI) requirements
The EU’s MDR is establishing a system equivalent to the Unique Device Identifier (UDI), developed by the FDA in the United States.
For companies to be MDR compliant, they must implement unique identifiers for all their devices in case of a recall.
Each identifier must include a serial number, lot/batch number, software identification and/or manufacturing or expiration date.
MDR technical documentation requirements
Compared to previous regulations, requirements for technical documentation are much stricter with MDR.
Annexes II and III of the legislation outline these requirements comprehensively and should be read by all manufacturers who aim to comply with the new regulations.
Annex II alone details more than 40 elements that must be present in the content of primary technical documentation for medical devices.
Annex III adds another 15 additional elements.
This highlights the importance of document control within manufacturers’ QMS if they hope to comply with new regulations satisfactorily.
QMS requirements for MDR
Unsurprisingly, QMS requirements are much stricter under MDR. While MDD referred to “directives”, MDR requirements are considered law and are consequently referred to as “regulations”.
Manufacturers must establish and implement a quality management system that includes document control, written policies and procedures, risk assessments for new and existing devices, and more.
The comprehensive list can be found in the MDR legislation under Article X.
Document control and QMS software from isoTracker
isoTracker offers modular, cloud-based quality management software including document control software.
This module makes adhering to document control requirements easier because it allows all employees to access and work on a document without the risk of duplication or accidentally working on the wrong version.
Our document control software provides automated version control and approval workflows, fine-grained document access control, review reminders, archiving and a full audit history. It’s an ideal tool for any company preparing for EU MDR compliance, or compliance with a range of other quality control standards.