Medical Device Regulation 2020: (MDR 2020)
The New Medical Device Regulation will come in to effect in 2020: Companies have three years to ensure that all currently marketed medical device products meet the new guidelines. It is imperative that manufacturers plan ahead and identify which of their products will be affected by the new classification and ensure that they remain compliant if they wish to continue operational in the EU market. Early preparation and adoption will be key to future success and some manufacturers may use the MDR 2020 as a way to differentiate themselves from their competition.
Which Industry will it impact the most?
The orthopaedics space will face the biggest challenge due to the changes in classifications. All hip, knee, shoulder and joint replacements were reclassified under the MDR 2020. This means that every device will require detailed review of technical documentation by the appropriate notified body, which will lead to wider scrutiny of clinical data to ensure patient safety.
What are the changes?
The new regulation will introduce new rules, including specific requirements addressing the classification of software. The new classifications cover diagnostic, therapeutic and physiological purposes, with the potential impact on patient safety and treatment determining the classification:
- Class III—software intended to provide information used to take decisions for diagnostic or therapeutic purposes that has the potential to cause death or an irreversible deterioration in health.
- Class IIb—software intended to provide information used to take decisions for diagnostic or therapeutic purposes that can cause the serious deterioration of a person’s health or a surgical intervention. Also covers software intended to monitor vital physiological parameters that could result in immediate danger to a patient.
- Class IIa—software intended to provide information used to take decisions for diagnostic or therapeutic purposes or to monitor physiological processes.
- Class I—all other software.
Another new rule covers the classification of active therapeutic devices. Products with an integrated or incorporated diagnostic function that significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, will now be classified as class III. Devices incorporating nanomaterial are addressed with a special new rule under the new MDR and they will now range from class I to class III, depending on the potential for internal exposure. Elsewhere, devices intended to administer medicinal products by inhalation, which are designed to treat potentially life-threatening conditions, will be up-classified from class IIa to IIb respectively. These are just some of the reclassifications. It will be important to study the new and amended classification rules for devices particular to your business.
Adopt Early to Stay Ahead
Manufacturers are responsible for ensuring their products will meet clinical data requirements and safety and performance requirements as per the MDR 2020. This may prove challenging for many legacy devices. Manufacturers, Notified Bodies and competent authorities will need to work together to provide practical solutions to the challenges of compiling, reviewing and accepting sufficient data.
Taking the time to start this process early will mean manufacturers remain compliant, competitive, and fully operational in the EU market.
General Data Protection Regulation (GDPR)
The GDPR is the new European Union (EU) legislation that modernizes and reforms the laws that address the handling of personal data. It replaces the European Data Protection Directive (95/46/EC) which was implemented inconsistently across Europe and did not have legislative authority.
Who does it apply to?
All 28 EU member states.
What does it apply to?
All EU citizens’ personal data, regardless of where it is collected, processed or stored. Any company who collects and stores personal data needs to comply with GDPT even if you don’t have a presence in the European market.
When does it come into effect?
There is a transition period of two years for organisations to implement compliant processes. The deadline is May 2018.
What are the exceptions?
The GDPR does not apply to the processing of personal data as it pertains to matters of national security or “purely personal or household activity”.
Main changes according to Opentext.com is as follows;
Data Minimization vs. Data Maximization
The principle of data minimization introduced by GDPR will be a big change for many companies. This principle advocates the collection of small amounts of data to a short period of time and then deleted as quick as possible after the completion of its specific purpose.