Regulatory affairs

In the field of medical devices, Regulatory Affairs encompasses all activities that ensure that a medical device meets the legal requirements for approval, placing on the market and surveillance activities in the respective target countries. Regulatory affairs is a central component of a company’s quality and approval management.

Approval strategy and planning

• Selection of the correct product classification (e.g. Class I, IIa, IIb, III in accordance with Regulation (EU) 2017/745 (MDR) / Class A, B, C, D in accordance with Regulation (EU) 2017/746 (IVDR))
• Regulatory requirements in the target markets (e.g. EU, USA, UK, Australia, Switzerland, …)

Preparation, maintenance and review of technical documentation

• Technical documentation according to MDR / IVDR Annex II & III
• Documentation for custom-made devices according to Annex XIII MDR
• Risk management file according to EN ISO 14971
• Clinical evaluation according to MDR
• Biological evaluation (EN ISO 10993)
• Research of EMDN codes (European Medical Device Nomanclature) for MDR and IVDR products
• Instructions for use and labeling

Communication with authorities and notified bodies

• Submission of documents for CE marking (e.g. to notified bodies)
• Response to queries and implementation of corrective actions
• Communication with authorities worldwide (e.g. EU authorities (BfArM etc.), FDA, MHRA, Swissmedic, TGA, …), but also with your local competent authority

Post-market surveillance (PMS) and reporting obligations (vigilance)

• Establishment and maintenance of PMS systems (in accordance with MDR Art. 83-86 / IVDR 78-81)
• Preparation of PMS reports and PSURs (Periodic Safety Update Reports)
• Reporting of serious incidents – in accordance with MDR Art. 87 / IVDR Art. 82
• Notification and support of recalls and corrective actions (Field Safety Corrective Actions – FSCAs / FSNs according to MDR Art. 87 / IVDR Art. 82)

Regulatory monitoring and support

• Monitoring of changes in regulatory requirements (e.g. new MDCG guidelines, harmonized standards, implementing acts, …) according to your request for your products
• Adaptation of internal processes to new requirements
• Advice to importers and distributors on compliance with regulatory requirements (MDR / IVDR Art. 13 / 14).
• Training on regulatory topics

Certifications and conformity assessment

• Support with CE marking (conformity assessment depending on risk class)
• Audit support for audits by notified bodies or authorities (e.g. inspections)

 

International market access

• Preparation and submission of notification documents outside the EU (e.g. USA – FDA 510(k), PMA), UK, Switzerland, Australia, New Zealand, …)