Compliance walkthrough
How to comply with the EU MDR (Regulation 2017/745): video walkthrough
A walkthrough of preparing medical devices for the EU market under Regulation (EU) 2017/745, from classification to the declaration of conformity and CE mark.
Key takeaways
- The MDR applies to any manufacturer placing devices on the EU market.
- Twenty-two Annex VIII rules set classes I, IIa, IIb and III.
- Notified bodies are involved for all but plain class I devices.
- Clinical evidence, technical documentation and post-market surveillance are central.
- There is no MDR certificate; the manufacturer declares conformity and affixes the CE mark.
The EU law for medical devices
The Medical Device Regulation is the European Union's law for medical devices, from wound dressings to implants and software. It applies directly in every Member State and reaches any manufacturer whose devices are placed on the EU market. It replaced the earlier medical device directives on 26 May 2021 and raised the bar on classification, clinical evidence, technical documentation, notified body scrutiny, traceability and post-market duties.
There is no MDR certificate to be awarded. The CE mark is affixed by the manufacturer under its own EU declaration of conformity; for all but plain class I devices, a notified body audits the quality management system, assesses the technical documentation and issues the EU certificates on which the declaration relies. This short film walks through how a manufacturer prepares.
Building the system and the files
Define the devices, the classes, the roles and the route: each device's intended purpose, its Annex VIII class and rule, whether an authorised representative is needed, the conformity assessment route and any legacy deadline. Class I, IIa, IIb or III follows from twenty-two classification rules, and sterile, measuring and reusable surgical class I devices need a notified body even though plain class I devices self-declare.
The manufacturer then establishes the quality management system the Regulation requires, builds technical documentation and clinical evidence for each device family, sets up post-market surveillance, unique device identification and EUDAMED registration, and appoints a person responsible for regulatory compliance. Internal audit tests the system before submission to a notified body designated for the MDR whose scope covers the devices. The notified body assesses and certifies; the manufacturer declares conformity and affixes the CE mark. Notified bodies work to the Regulation, the harmonised standards and MDCG guidance.
Sterling's expert and experienced consultants prepare the QMS, the technical documentation and your team under Sterling OS™, and support the person responsible for regulatory compliance. The Regulation has been amended to extend transition periods, and a simplification proposal is not yet law, so deadlines should be checked for each device.
EU MDR 2017/745 at a glance
- Purpose
- CE marking of medical devices for the EU market, backed by a quality management system, assessed technical documentation, traceability and post-market surveillance
- Relevant to
- Legal manufacturers anywhere in the world placing devices on the EU market, their authorised representatives, importers and distributors, and their suppliers
- Edition
- Regulation (EU) 2017/745, applicable since 26 May 2021, as amended by Regulations (EU) 2020/561, 2023/607 and 2024/1860; the Commission's simplification proposal of 16 December 2025 is not yet law
- Certification
- No "MDR certificate" as such. A notified body designated by an EU Member State assesses the QMS and technical documentation above basic class I; the manufacturer signs the EU declaration of conformity and affixes the CE mark
- Sterling's role
- QMS, technical documentation, PRRC support, UDI and EUDAMED, internal audit and notified body readiness with your team, Effivity, training, then Sustain™
- Cost and timing
- Total investment for EU MDR compliance depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 9 to 18 months, before the notified body's review
EU MDR 2017/745: questions people ask
Is there such a thing as EU MDR certification?
Not in the way ISO certification exists. The outcome is the CE mark, affixed by the manufacturer under its own EU declaration of conformity. Where a notified body is involved it issues the EU certificates listed in Annex XII. An "MDR certificate" from a consultant or a certification body is not one of them.
Does our ISO 13485 certificate make us MDR compliant?
No. EN ISO 13485:2016 with A11:2021 is harmonised under the MDR, so conformity gives a presumption of conformity for the requirements it covers. It does not cover the regulatory strategy, the Annex I requirements, UDI, the PRRC, PSURs, vigilance timelines or EUDAMED, and it is certified by an accredited certification body, not a notified body.
Which devices need a notified body?
Every class IIa, IIb and III device, and class I devices placed on the market sterile, with a measuring function or as reusable surgical instruments, for those aspects. Only plain class I devices are self-declared. Classification under Annex VIII is the manufacturer's responsibility; get it wrong and the whole route is wrong.
What is a notified body, and how do we choose one?
A conformity assessment body designated by an EU Member State to audit quality systems and assess technical documentation under the MDR; the designated bodies and their scopes are listed in the Commission's NANDO database. Choose one whose scope covers your device codes and whose capacity matches your deadline. Sterling is not a notified body.
Do we need a person responsible for regulatory compliance, and can it be outsourced?
Every manufacturer needs at least one PRRC with the Article 15 qualifications. Micro and small enterprises need not employ the person but must have one permanently and continuously at their disposal. Whoever holds the role signs off release, documentation, surveillance and vigilance, so the arrangement has to be real.
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