top of page

Diseño sin título (35).png

MEDICAL DEVICES

Global Regulatory Compliance for Medical Devices

From CE marking under the EU MDR to FDA clearance or approval through 510(k) or PMA pathways, we guide you through the regulatory process required to place your medical device on international markets.

Regulatory Complexity is Increasing

Medical devices are among the most strictly regulated products worldwide.

Requirements vary significantly depending on the device classification, intended use and target market.

Navigating this regulatory environment requires specialised expertise.

MEDICAL DEVICES

What-is-PIF-Europa

Each jurisdiction applies specific requirements for:

Risk classification
Clinical evaluation and safety evidence
Technical documentation
Quality management systems
Post-market surveillance

Medical Device Classification

Regulatory requirements depend on the device’s intended purpose and risk classification.

Class I
Low-risk devices

Examples: bandages, basic instruments

Limited regulatory requirements

Class IIa
Medium-risk devices

Examples: diagnostic equipment, dental devices

Usually require conformity assessment

Class IIb
High-risk devices

Examples: ventilators, infusion pumps

Require Notified Body involvement

Class III
Critical risk devices

Examples: implants, pacemakers

Require robust clinical evidence and strict conformity assessment

Discuss Your Device Classification

REGULATORY PRINCIPLES

Key Regulatory Requirements

01

02

03

04

05

Risk Classification

Clinical Evaluation

Technical Documentation

Conformity Assessment

Devices are classified according to their intended purpose and level of risk.

Clinical evidence is required to demonstrate safety and performance.

The technical file must demonstrate conformity with applicable regulatory requirements.

Assessment by competent authorities, Notified Bodies or recognised bodies, depending on the market and device class.

Post-Market Surveillance

Ongoing monitoring of device safety and performance after market launch.

Regulacion y comercializacion de productos

In which market do you want to market your product?

We help you meet regulatory requirements and successfully access each market

European
Union

CE marking according to MDR 2017/745
Intervention of a Notified Body, when applicable
Clinical Evaluation Report (CER)
Post-market surveillance

United
Kingdom

UKCA Marking
Registration with the MHRA
UK Responsible Person
Post-marketing requirements

United
States

FDA/CDRH regulatory pathway
510(k), De Novo or PMA
Establishment registration and product listing
Quality system requirements

Canada

Medical Device Licence (MDL)
Health Canada Requirements
MDSAP Certification
Post-market surveillance

UAE

MOHAP / relevant authority registration
Local Authorised Representative
Import requirements
Alignment with international standard

KSA

SFDA medical device registration
Product listing
Local Authorised Representative
Applicable SFDA / SASO requirements

Türkiye

ÜTS / TİTCK registration
Technical documentation review
Local authorised representative
Post-market surveillance

Australia

TGA requirements
Inclusion in the ARTG
Conformity assessment
Post-market obligations

Ready to bring your medical device to market?

Our regulatory experts guide you through every stage, from classification to approval.

bottom of page