In August of 2020, Legal Notice L.N. 321 was published which brought in Subsidiary Legislation S.L. 458.59 which had a great impact on the way in which medical devices and IVDs are regulated in Malta. Amongst the changes introduced by the Subsidiary Legislation, the requirement for stakeholders to have a Medical Device Registered Person (MDRP) within their organisation is perhaps one of the trickiest to comply with. Stakeholders include those organisations based in Malta who are carrying out the following in relation to medical devices intended to be placed on the EU or local market:
S.L. 458.59 provides little detail and guidance on the MDRP’s responsibilities or eligibilities. However, the Malta Medicines Authority (MMA) has released helpful guidance document GL-MDS01/01 titled ‘Guidance for Good Distribution Practice in relation to Medical Devices’. The document aims to provide guidance to local economic operators to comply with the obligations of the EU Regulations on Medical Devices and IVDs [2017/745/EU(MDR) and 2017/746/EU(IVDR)], as well as local legislation.
Role of the MDRP #
In relation to the MDRP’s responsibilities, GL-MDS01/01 indicates that they will be responsible to ensure that the “Quality System is properly administered and can consistently support the fulfillment of all legal requirements“. Annex I of the guidance document is dedicated to the role and eligibility of an MDRP. There, the document states that the MDRP is responsible for ensuring that organisation adheres to all applicable legislation and guidance with respect to the making available and placement of medical devices and IVDs on the market. Their responsibilities include the following:
- Ensuring that medical devices placed on the market comply with the legislation.
- Keeping a copy of the EU declaration of conformity (DoC), instructions for use (IFU) and labelling of the device, and, if applicable, a copy of any relevant certificate, including any amendments and supplements in accordance with the Regulations.
- Verifying that the device is registered with the European databank (Eudamed) and notified in the national medical device database.
- Ensuring that an organisation’s quality system is developed, properly administered and can consistently support the fulfilment of all legal requirements.
- Ensuring that while a device is under their responsibility, storage and transport conditions comply with the general safety and performance requirements found in the legislation as well as the conditions set by the manufacturer.
- Ensuring that an appropriate level of traceability of devices is kept by means of detailed documentation and record-keeping systems.
- Ensuring complaints and incident reports from Healthcare Professionals, patients or users will be forwarded to the manufacturer, and his authorised representative if applicable, as well as the national competent authority.
- Liaising with manufacturers in collecting information and dealing with preventive, corrective and field safety corrective action.
- Informing the national competent authority if a device is believed to present serious risk or is suspected to be falsified.
- Coordinating recalls.
- Keeping a register of complaints, of non-conforming devices, recalls and withdrawals.
The above responsibilities are directly linked to the obligations of importers and distributors, as indicated in Articles 13 and 14 of the EU MDR and IVDR. A good understanding of these obligations will be key for any MDRP.
MDRP Eligibility #
Can anyone qualify as an MDRP? Not quite.
As indicated previously, the MDRP should be someone who is knowledgeable about the requirements and obligations of the economic operator. GL-MDS01/01 goes several steps further and indicates precise eligibility criteria for individuals and personnel who can fill this role:
- Applicant is either an EU citizen (providing proof through a valid passport or identity card document) or if a non-EU citizen has a permanent Maltese residence and a Maltese working permit (providing relevant documentation);
- One of the following criteria related to qualifications / experience:
- In possession of one of the following qualifications: 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 Malta, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one (1) year of professional experience in regulatory affairs or in quality management systems related to medical devices;
- Two (2) years of professional experience in regulatory affairs or in quality management systems related to medical devices;
- A course recognised by the Malta Medicines Authority related to medical devices.
Meeting the above criteria, the individual shall apply with the MMA using the MT-MDF11 Application Form, providing evidence of the above. A registration fee shall apply.
How We Can Help #
We offer training that has been specifically constructed to give a detailed overview of the EU Regulations and local legislation, relevant to the obligations and responsibilities of the Medical Device Registered Person. This will help you meet the eligibility criteria above. Training Services.
Should you have any further questions, please get in touch!