Are you a Medical Device Manufacturer or an Authorised Representative supplying product in the EU market? Do you understand your obligation to appoint a Person Responsible for Regulatory Compliance under the new EU MDR and IVDR legislation?

Are you a Medical Device Manufacturer or an Authorised Representative supplying product in the EU market? Do you understand your obligation to appoint a Person Responsible for Regulatory Compliance under the new EU MDR and IVDR legislation?

Billed as the most significant change to the medical device legislation in decades, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices Regulation (IVDR) – Regulation (EU) 2017/746 seek to increase the safety and effectiveness of medical devices available in the EU market. One aspect of this new legislation is the requirement to appoint a Person Responsible for Regulatory Compliance. This requirement has an impact on manufacturers and authorised representatives supplying medical device and in vitro diagnostic product in the EU market.

Who will be required to appoint a Person Responsible for Regulatory Compliance?

The regulations require that manufacturers and authorised representatives have permanently, and at their disposal, at least one person responsible for regulatory compliance. This isn’t necessarily an employee, but a service that is provided by a person that must be accessible to the organisation. The person is responsible for ensuring the conformity of devices are checked prior to release, including that technical documents and certificates of conformity are accurate.

What are the obligations for organisations not established in the Union?

Regardless of your location around the world, if your organisation is supplying medical device and/ or in vitro diagnostic product in the EU market, you will be required to appoint a Person Responsible for Regulatory Compliance.

What are the qualifications of a Person Responsible for Regulatory Compliance?

Accepted qualifications for a Person Responsible for Regulatory Compliance are either of the following:

‘(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;

(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.’[1]

What are the responsibilities of a Person Responsible for Regulatory Compliance?

A Person Responsible for Regulatory Compliance 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.’[2]

What do I need to do from here?

Companies should incorporate the potential requirement to appoint a Person Responsible for Regulatory Compliance in their compliance plans. To understand if your organisation is impacted, a review of the general obligation statements in relevant articles should be performed.

For companies obligated to appoint a Person Responsible for Regulatory Compliance, you should identify an individual that meets the qualifications. There’s a possibility that larger companies have already got the capabilities to meet this role. However, the likelihood is that many smaller companies will have to search outside their organisation to find a Person Responsible for Regulatory Compliance.

Once a Person Responsible for Regulatory Compliance has been identified, companies will need to focus on how they will introduce this new responsibility within their organisation. Companies should consider updating the relevant processes to transition to this new way of working. Overall, this will better enable companies to meet the timelines of the legislation and the re-registration of their products by May 2020 and May 2022.

Summary

As can be seen from the above, it is essential to ensure that you meet the general obligations for a Person Responsible for Regulatory Compliance in the new regulations. An assessment and action plan will help ensure a successful outcome for your organisation.

If you are impacted by EU MDR / IVDR, start planning how to transition to the new requirements and avoid supply interruptions. Our Executive Briefing, An Introduction to the EU Medical Device Regulation (EU MDR)  can help you understand the legislation and develop a strategy for transition.

I hope you found this information useful and helpful. Should you have any questions about this, or any of my other blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

References

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on Medical Devices

[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on Medical Devices

[2] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April on Medical Devices