At the end of the 4-year transition period, MDR applications started on May 26, 2021. One of the important changes for the medical device manufacturers is the appointment of a "Person Responsible for Regulatory Compliance" within the company as mentioned in article 15 of the MDR (2017/745).
The criteria for the assignment of the “Person Responsible for Regulatory Compliance” have been determined as follows.
“The requisite expertise shall be demonstrated by either of the following qualifications:
- (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.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.”
While assigning these persons, a privilege was granted to Micro and Small-scale enterprises that meet the criteria indicated in red in the table below, and they were allowed to appoint a "Person Responsible for Regulatory Compliance" from outside the firm.
| Firm scale | Number of Employees <10 | Number of Employees <50 | Number of Employees <250 |
| Turnover<2.000.000 Euro | On Payroll or Outside | On Payroll or Outside | On payroll |
| Turnover<10.000.000 Euro | On Payroll or Outside | On Payroll or Outside | On payroll |
| Turnover<50.000.000 Euro | On payroll | On payroll | On payroll |
Persons appointed as Responsible for Regulatory Compliance will be responsible for:
- Checking the conformity of the device to the QMS before its release,
- Preparing the technical documentation and the Declaration of Conformity as well as keeping them up-to-date.
- Meeting the post-market surveillance (PMS) requirements,
- Meeting the reporting requirements to Competent Authorities within the scope of vigilance,
- Preparing general safety and performance declaration for investigational devices.
You may see below the summary of related MDR Chapters so that you can easily access the framework of the documents that need to be prepared.
a. “Post-market surveillance system of the manufacturer” (EU 2017/745 Chapter VII Article 83)
b. “Reporting of serious incidents and field safety corrective actions” (EU 2017/745 –Article 87)
c. “Trend Reporting” (EU 2017/745 – Article 88)
d. “Analysis of serious incidents and field safety corrective actions” (EU 2017/745 - Article 89)
e. “Analysis of vigilance data” (EU 2017/745 – Article 90)
f. “Implementing acts” (EU 2017/745 – Article 91)
g. if there are devices for investigational purposes (Annex XV, Chapter II, Article 4.1.)
