Top 5 Medical Devices Regulation Hazards to Avoid

February 14, 2020

As of May 2020, regulations governing medical devices as part of the European Union’s Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) will be replaced by the Medical Devices Regulation (MDR).

If your organisation operates in the medical device industry, don’t let compliance with previous regulations lull you into complacency.

As with the General Data Protection Regulation (GDPR), MDR represents wholly new requirements and features many changes, such as product scope expansion, the implementation of unique device identification, reclassification of medical devices and much more.

And just as many were reminded with GDPR, “regulations” are enforced at the local level and must be rolled out as is, in stark contrast to “directives,” which are open to interpretation by regional lawmakers.

Among other consequences, noncompliance with MDR may result in products being removed from the market, as well as organisations being banned from marketing their devices in the EU completely.

Read on to discover the top five MDR hazards your organisation needs to avoid.

1. Assuming Compliance isn’t Mandatory

Unlike MDD and AIMDD, where local laws differed, MDR will be rolled out uniformly across all European regions. Even if you’re manufacturing devices outside of Europe to be sold in Europe or are a UK-based organisation exiting the EU, compliance is mandatory. You’re likely to receive questions about how your organisation will comply with MDR from prospects and customers, so make sure the content your customer-facing employees need to put buyers’ minds at ease is easy to find, access and share. If adjustments are made to MDR after the go-live date, salespeople will need to be prepared to speak to changes immediately, so be sure all content related to MDR can be updated quickly.

2. Not Understanding the Expanded Scope

More devices fall under the domain of MDR than did under MDD and AIMDD. For example, if your organisation manufactures coloured contact lenses or tools for predicting health conditions that work with the body or have a health-related function, they fall under the regulation’s purview. Bite-sized videos, FAQ sheets, checklists and quizzes can all be highly effective ways to ensure people in your organisation understand how changes under MDR may affect certain products and services.

3. Misinterpreting Timelines

MDR goes into effect in May 2020, but unless you’re selling a new category of medical device (such as those mentioned above), existing regulatory certificates will still be valid for five years from their start date, or four years if the start date was in 2020. This is essential information to pass on to customer-facing employees, as some of your organisation’s customers may be worrying that you have less time to re-certify and therefore may no longer be a sustainable partner. With that said, keep in mind that all devices must be recertified eventually. No devices will “inherit” certification from related products or be exempt if they were in existence prior to MDR.

4. Failing to Designate a PRRC

While your organisation may have an authorized representative to register devices, be identified on device labeling and assist with other regulatory compliance duties, MDR requires the creation of a new role known as Person Responsible for Regulatory Compliance (PRRC). Among other responsibilities, a PRRC must ensure devices conform with quality management system procedures before release, keep technical documentation and declarations of conformity up to date and assure compliance with all postmarket surveillance and reporting obligations. Not only is it important to update your organisation on who this person is and their qualifications in order to direct specific inquiries to them, it’s also beneficial to train and test your organisation at large to make sure everyone understands the rules regarding the new regulation.

5. Underestimating Enforcement

Enforcing bodies in different regions will carry out spot checks, audits and sample tests, as well as request detailed product histories and documentation regarding safety checks. Often inquiries can be referred to your organisation’s “qualified person,” but in some cases sales reps may also have to answer questions. Ongoing coaching will help all customer-facing employees develop the knowledge necessary to provide enforcing bodies and buyers alike with fast, reassuring answers.

New regulations such as MDR may be standard practice for professionals in the medical device industry, but don’t misjudge the anxiety they can cause among prospects and customers.

Ensuring your organisation has the content, training and coaching necessary to effectively answer questions and demonstrate compliance with MDR isn’t just vital under the regulation, it’s essential to delivering a winning buyer experience.

Interested in solutions to help your organization stay successful under MDR? Check out our new blog post, “3 Solutions for Successful Sales Under MDR.”