Answered From Primary Legislation, Not Opinion

If you're building a medical device and selling into the EU, you've probably already run into the alphabet soup: MDR, PRRC, QMS, CER, EUDAMED. And you've probably been given a lot of opinions about what all of it means.

This post is different. Every answer below comes directly from Regulation (EU) 2017/745, the actual law, not from a consultant's interpretation of it. Where a specific article applies, we've cited it. You can look it up yourself.

Q1: Is my product actually a medical device under MDR?

This is the right first question, and most startups skip it.

Under Article 2(1) of MDR 2017/745, a medical device is any instrument, apparatus, appliance, software, implant, material, or other article intended by the manufacturer to be used for a medical purpose, covering diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease or injury.

The key word is intended. The regulation classifies your product based on what you say it does, not just what it technically does. A wearable that tracks heart rate for fitness is not a medical device. The same wearable marketed to detect arrhythmia probably is.

Software gets its own sub-definition. Article 2(1) explicitly includes software intended by the manufacturer to be used, alone or in combination, with a medical device. MDCG guidance 2019-11 goes further on Software as a Medical Device (SaMD).

Practical answer: Write your intended purpose statement before you decide whether MDR applies to you. Your intended purpose determines your regulatory pathway. Get it wrong early and you'll fix it expensively later.

→ Not sure if MDR applies to your product?  Health Tech Pathways offers a free "MDR or not" assessment: a structured tool that walks you through the key qualification questions based directly on Article 2(1), so you get a clear answer before committing time or budget to a regulatory pathway.

Q2: How do I know which class my device is?

Classification is set out in Annex VIII of MDR 2017/745. There are 22 rules, covering everything from non-invasive devices (Rule 1) to active implantable devices (Rule 8) to software (Rule 11).

Devices fall into one of four risk classes:

•       Class I: lowest risk (e.g. bandages, most non-sterile non-measuring devices)

•       Class IIa: moderate risk (e.g. short-term invasive devices, dental fillings)

•       Class IIb: higher risk (e.g. ventilators, infusion pumps)

•       Class III: highest risk (e.g. implants, devices in direct contact with the central nervous system)

Article 51 states that classification is determined by the manufacturer, applying the rules in Annex VIII. If there is disagreement, the relevant Competent Authority or Notified Body makes the final call.

For software specifically, Rule 11 applies. The class depends on what the software does: if incorrect information from the software could cause serious deterioration or death, it is likely Class IIb or Class III.

Practical answer: Start with Annex VIII. Read your intended purpose against each rule. If two rules could apply, Article 51(3) says the stricter classification wins. If genuinely unsure, request a classification opinion from your national Competent Authority. This is called the Helsinki Procedure.

→ Health Tech Pathways classifies your device directly against the Annex VIII rules.  Rather than relying on generic guidance, the HTP platform maps your device's characteristics and intended purpose to the exact law text, giving you a classification rationale that is traceable, defensible, and ready for Notified Body review.

Q3: Do I need a Notified Body?

It depends on your class, and the answer is in Article 52 of MDR 2017/745.

•       Class I devices (non-sterile, non-measuring, non-reusable surgical instruments): You self-certify. No Notified Body required.

•       Class I sterile or measuring devices: You need a Notified Body for the sterility or measurement aspects only.

•       Class IIa, IIb, and III: You need a Notified Body for conformity assessment. No exceptions.

As of 2026, there are fewer than 50 designated Notified Bodies across the EU, and wait times for audits can stretch from several months to over a year depending on device type and NB capacity. Build this timeline into your launch plan.

Practical answer: If you are Class IIa or above, contact a Notified Body early, before your technical documentation is complete. Secure your audit slot as soon as possible.

Q4: What's a PRRC, and do I need one?

Yes, you need one. Article 15 of MDR 2017/745 requires every manufacturer and authorised representative to have a Person Responsible for Regulatory Compliance (PRRC).

This person is responsible for:

•       Confirming devices meet QMS requirements before release

•       Ensuring technical documentation and Declarations of Conformity are in order

•       Meeting post-market surveillance obligations under Article 10(10)

•       Fulfilling vigilance reporting under Articles 87-91

Qualifications under Article 15(1): A university degree in law, medicine, pharmacy, engineering, or a relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or quality management for medical devices. Alternatively, four years of relevant professional experience without a degree.

The SME exception (Article 15(2)): If your company has fewer than 50 employees and annual turnover or balance sheet under 10 million euros, you can outsource the PRRC role to an external contractor. They must still be permanently and continuously at your disposal.

Practical answer: Most early-stage startups qualify for the SME provision. You can contract a PRRC from day one rather than hiring full-time. Document the arrangement formally and verify the PRRC's CV meets Article 15(1) criteria, as the Notified Body will check.

Q5: Do I need a Quality Management System from day one?

Yes. Article 10(9) of MDR 2017/745 requires all manufacturers to establish, document, implement, maintain, and continually improve a QMS, regardless of device class.

The QMS must cover:

•       Regulatory compliance strategy

•       Risk management (aligned with ISO 14971)

•       Clinical evaluation

•       Post-market surveillance

•       Vigilance and incident reporting

•       Corrective and preventive actions (CAPA)

•       Supplier controls

For Class I non-sterile, non-measuring devices, your QMS does not need to be third-party certified. For Class IIa and above, the Notified Body will audit your QMS under Annex IX. ISO 13485:2016 is the internationally recognised standard that aligns with MDR QMS requirements.

Practical answer: Start building your QMS in parallel with product development, not after it. The most common source of Notified Body delays is not missing documents. It is documents that contradict each other. Your QMS is the connective tissue that keeps your technical file consistent.

→ Health Tech Pathways structures your QMS journey against the actual law.  The HTP platform uses AI trained specifically on MDR 2017/745 to guide you through each Article 10(9) requirement in sequence, generating structured outputs, flagging gaps, and keeping your technical documentation consistent from day one. This is the difference between building a QMS and building one that holds up under audit.

Q6: What are the current transition deadlines?

This changed. The amended regulation, Regulation (EU) 2023/607, extended the original deadlines. Here is where things stand as of 2026:

•       Class III implantable custom-made devices: Must comply by 26 May 2026

•       Class III and Class IIb implantable devices: Must comply by 31 December 2027

•       Class IIa, Class IIb (non-implantable), and Class I (sterile/measuring): Must comply by 31 December 2028

These deadlines apply to devices already certified under MDD or AIMDD. Devices new to market must comply with MDR now. No transition period applies to them.

Practical answer: If you are a new startup launching a new product, the transition deadlines do not help you. You are in scope for MDR from the moment you intend to CE mark. Plan accordingly.

Q7: What is a Clinical Evaluation, and do I have to do one?

Yes. Article 61 of MDR 2017/745 requires every manufacturer to conduct and document a clinical evaluation for every device, regardless of class.

The clinical data supporting the evaluation can come from:

•       Clinical investigations you conduct yourself

•       Literature reviews of published scientific data on equivalent devices

•       Post-market clinical follow-up (PMCF) data once the device is on market

For high-risk devices (Class III and certain Class IIb), the concept of clinical equivalence is tightly restricted under Annex XIV, Part A. To claim equivalence with a competitor's device, you must have access to their technical documentation, which is rarely available without a formal contract.

Practical answer: Do not treat the CER as a document you write at the end. It is a process that starts during development. The earlier you define your clinical claims, the earlier you can identify what data you need to support them.

Q8: What is EUDAMED, and when do I need to register?

EUDAMED is the European Database on Medical Devices. Article 33 of MDR 2017/745 requires manufacturers, authorised representatives, importers, and devices to be registered in EUDAMED before market entry.

Registration gives you a Single Registration Number (SRN), which must appear on labelling and in technical documentation. Each device also receives a Unique Device Identifier (UDI) under Article 27, linked to its EUDAMED record.

As of 2026, four of EUDAMED's six modules become mandatory from 28 May 2026, including device registration and UDI modules. Check the current schedule on the European Commission's EUDAMED pages, as phasing has shifted before.

Practical answer: Register in EUDAMED early. It is free, and it is a prerequisite for CE marking. Delaying this step will delay everything downstream.

One thing worth saying clearly

The MDR is long: 175 articles, 17 annexes, and years of MDCG guidance stacked on top. But most of the genuinely confusing situations for startups come down to three things: not defining the intended purpose early enough, underestimating how much clinical evidence is required, and treating the QMS as paperwork rather than infrastructure.

The regulation itself is public and free to read on EUR-Lex. The MDCG guidance documents are on the European Commission's health website. Neither requires a consultant to access.

Know where the law actually says what it says. It makes every conversation you have with a Notified Body, a Competent Authority, or an investor much more grounded.

Want a faster path through the process?

Health Tech Pathways was built specifically for medical device startups navigating MDR. Start with the free "MDR or not" assessment to immediately clarify whether your product is in scope. From there, the HTP platform classifies your device against the actual Annex VIII law text, and guides you through the certification process using AI trained specifically on MDR 2017/745, so you move faster, waste less time on rework, and arrive at your Notified Body audit with a file that holds together.

https://healthtechpathways.org/

All regulatory references relate to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, as amended by Regulation (EU) 2023/607. Always verify against the current EUR-Lex version, as amendments continue to be published.