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person responsible for regulatory compliance

Why a person responsible for regulatory compliance is crucial in 2021

The rise of the person responsible for regulatory compliance

2021 has been an interesting year for many of us, especially regulatory compliance and regulatory affairs teams around the world. Since the start of the pandemic, regulatory compliance and affairs has had a re-brand, moving from ‘just another department’ to a key strategic partner for many businesses. This raised profile has highlighted the fact that regulatory compliance is not just about knowing the rules and regulations inside out – it’s also about exceptional negotiation skills, proactive and reactive creativity, multidisciplinary communication skills and being able to navigate the grey where other teams can’t. It’s regulatory affairs professionals who sit at the forefront of bringing products to market quickly – a responsibility which has been more important than ever in the face of Coronavirus and the need for vaccines and virus detection medical devices.

It’s not just the pandemic that has raised the global profile of regulatory affairs compliance professionals. The European Commission’s guidance in response to the new MDR 2017/745 and IVDR 2017/746, says that manufacturers and authorised representatives must have at least one member of staff who is a designated person responsible for regulatory compliance (PRRC) to the MDR and/or IVDR. So, if you’re a medical device manufacturer or authorised representative then it’s imperative that you have a PRRC on your team.

What will a person responsible for regulatory compliance do?

Under MDR 2017/745
According to Article 15(3) of the EU MDR 2017/745, the PRRC of a medical manufacturer is responsible for ensuring that:

(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);

(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled.

(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Under IVDR 2017/746

For PRRCs working according to Article 15(3) of the EU IVDR 2017/746, their responsibilities are:

(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with Article 10(9);

(d) the reporting obligations referred to in Articles 82 to 86 are fulfilled.

(e) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.

What makes a great PRRC?

Your person responsible for regulatory compliance needs to be a fantastic communicator, as they’ll need to communicate across different layers of your business, with customers and with external certifying bodies. They’ll need to have a demonstrable background of technical, protocol and report driven work, with fantastic attention to spoken and written detail. A great PRRC will also be able to show their experience in working with a flexible, proactive and hands-on approach to their work.

According to MDR 2017/745, the person responsible for regulatory compliance should have:

a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices

or

(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices

For IVDR 2017/746, the PRRC’s experience must pertain to in vitro medical devices.

When it comes to adding a person responsible for regulatory compliance to your team, you have a few options to consider. The first is to look internally for someone who has the required skills and experience. If there is no one suitable, you can either:

– Hire a new employee that will fulfil this role

– Hire a consultant for a certain period of time until one of your internal employees gets trained

PRRCs are in high demand right now and competition for the best ones is high! We’re on hand with our highly coveted network of over 20,000 MedTech professionals to not only help you find the best person for the job, but to also make sure they join your company and not a very attractive competitor.

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