The new AEMPS instruction on the procedure to obtain the manufacturing licence is a long-awaited document for medical device (MD) and in vitro diagnostics (IVD) manufacturers and regulatory affairs consultants in the MedTech industry.
The previous instruction (PS 1/2019) included relevant information for devices marketed under the directives (MDD, AIMDD, IVDD). Now, the AEMPS has updated the instruction with the primary objective to include the requirements for devices under the scope of the MDR (Regulation EU 2017/745) and IVDR (Regulation EU 2017/746).
What is the manufacturing licence?
This licence, which in Spain can also be referred to as “prior operating license for medical device installations”, is required in certain EU countries prior to manufacturing and marketing MDs and IVDs.
The process to obtain the manufacturing licence differs from country to country. Manufacturers should check the requirements for the countries where they, or their authorised representative, have their legal place of business. In this article, we are only covering the manufacturing license process for Spain.
In Spain, the national competent authority, i.e. the AEMPS, is the responsible organism that provides the manufacturing licence.
How to obtain the manufacturing licence?
To date, the AEMPS has published two instructions that include all the information needed to obtain the manufacturing licence:
- PS1/2019: this instruction applied to manufacturers aiming to certify their products under the directives MDD, AIMDD or IVDD. This instruction has been obsolete since 26th May 2022.
- PS1/2022: this instruction has been recently published and applies to manufacturers with products under the scope of the regulations MDR or IVDR.
Although new requirements to comply with the EU regulations have been included in the instruction PS1/2022, both PS1/2019 and PS1/2022 are based on the same Spanish Royal Decrees (RD) that date from the 2000s, and that transposed the EU directives (RD 1662/2000, RD 1591/2009, RD 1616/2009, RD 437/2002, Ley 39/2015). Therefore, the RD is not yet aligned with the requirements of the European regulations and the AEMPS has informed that an updated instruction will be released once the RDs are published.
Differences and similarities between PS1/2019 and PS1/2022
In general, requirements between PS1/2019 and PS1/2022 are quite similar since they both stem from the same RD as mentioned above. The main difference between the instructions is the requirement to appoint a person responsible for regulatory compliance (PRRC) in PS1/2022, which was not included in the previous instruction. Below, you can find a table comparing both instructions.
What are the process and timelines?
The figure below summarises the process for obtaining the manufacturing license and the approximate timelines expected for the review of the submitted documentation. Once the submission is reviewed by the AEMPS, several amendment periods can be opened to update or provide more documents. When all the requirements stated by the AEMPS have been fulfilled and the license obtained, the company will be inspected to ensure the provided procedures are implemented and maintained and the facilities and resources’ requirements for manufacturing the medical device have been met.
Figure 1 – Schematic representation for obtaining the manufacturing license.
What can AKRN provide?
AKRN experts can guide you through the whole manufacturing license process:
- Develop documentation in compliance with ISO13485 to support your QMS.
- Development of documentation in compliance with the EU Regulations
- Guide the process to ensure timelines are met on time
- AEMPS package compilation and submission
- Support communication with AEMPS
- Guidance on PRRC, Vigilance and Post-market phases
Subject Matter Experts
José Velazquez, M.Sc.
Quality Assurance Manager LinkedIn
Arancha López-Pérez, Ph.D.
Regulatory Affairs Scientist LinkedIn
