Compliance Checklist

CE Marking
Health & Medical
Germany 🇩🇪

CE marking for medical devices and health products on Amazon Germany: MDR requirements, risk classification, BfArM registration, costs and common mistakes.

Overview

Medical devices and health products in the EU are subject to the Medical Device Regulation (MDR) (EU) 2017/745 or the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. CE marking is mandatory for all medical devices and signals conformity with these regulations. Depending on the risk class (I, IIa, IIb, III), involvement of a Notified Body is required. Important: Not every health product is a medical device – the distinction from wellness products is critical and has significant regulatory consequences. General wellness and health products without a medical intended purpose (e.g. massage devices for relaxation, fitness trackers without medical claims) instead fall under the Low Voltage Directive (2014/35/EU), the EMC Directive (2014/30/EU), and for Bluetooth/WiFi functionality under the Radio Equipment Directive (2014/53/EU).

Does this apply to my product?

The CE marking obligation under MDR applies to all products with a medical intended purpose sold on Amazon.de: blood pressure monitors (Class IIa), clinical fever thermometers (Class IIa), blood glucose meters, pulse oximeters (Class IIa), wound care, orthopedic aids, compression stockings, medical masks, inhalation devices, TENS devices (Class IIa), hearing aids (Class IIa) and in vitro diagnostics such as pregnancy tests or COVID self-tests. Critical distinction: hearing amplifiers (Personal Sound Amplification Products, PSAPs) are NOT medical devices, while actual hearing aids are – the intended purpose decides. Similarly, fitness trackers without medical claims are pure consumer products (CE under LVD/EMC/RED), while a fitness tracker with blood pressure measurement function and diagnostic claims becomes a medical device.

Step-by-Step Guide

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Distinguish medical device vs. wellness product and determine risk class

The first and most important decision: Is your product a medical device within the meaning of the MDR? If so, which risk class does it fall into? This classification determines the entire subsequent certification process.

Estimated time: 1-2 Wochen

Intended purpose defined and documentedRequired

The intended purpose determines whether your product is a medical device. A massage device 'for relaxation' is a wellness product and falls under the Low Voltage Directive (LVD 2014/35/EU) and EMC Directive (2014/30/EU). A massage device 'for treatment of muscle tension' is a medical device and falls under the MDR (EU) 2017/745. The wording on listing, packaging and manual must be consistent – even with fitness trackers the boundary is fluid: without medical claims LVD/EMC/RED applies, with diagnostic claims it becomes a medical device. Particularly critical is the distinction between hearing amplifiers (PSAPs, not a medical device) vs. hearing aids (medical device Class IIa).

Risk classification according to MDR Annex VIII completedRequired

The MDR has four risk classes: Class I (lowest risk, e.g. plasters, wheelchairs), Class IIa (e.g. blood pressure monitors, contact lenses), Class IIb (e.g. ventilators, defibrillators), Class III (highest risk, e.g. pacemakers, hip implants). The 22 classification rules in Annex VIII determine the classification.

Classification report with justification of applied rules from MDR Annex VIII

Checked whether IVDR applies instead of MDR (for in vitro diagnostics)Required

In vitro diagnostics (pregnancy tests, blood glucose test strips, COVID tests) do not fall under the MDR but under the IVDR (EU) 2017/746. The IVDR has its own classification system (Classes A, B, C, D) and different requirements for Notified Bodies.

Quality management system (QMS) and clinical evaluation

The MDR requires a complete quality management system and clinical evaluation for all medical devices – including Class I. This is a significant change from the former MDD.

Estimated time: 4-16 Wochen

QMS according to EN ISO 13485:2016 implementedRequired

EN ISO 13485 is the standard for quality management systems for medical devices. The QMS must cover design control, risk management, supplier evaluation, complaint handling, CAPA processes and vigilance reporting. For Class I, a simplified QMS is sufficient.

QMS documentation according to EN ISO 13485 (manual, SOPs, work instructions)

Risk management according to EN ISO 14971 completedRequired

A comprehensive risk analysis is mandatory for every medical device. It must cover the entire lifecycle: use, misuse, transport, storage, disposal. Methods: FMEA, fault tree analysis, risk-benefit assessment.

Risk management report according to EN ISO 14971

Clinical evaluation according to MDR Article 61 completedRequired

The clinical evaluation assesses safety and performance based on clinical data. For Class I, a literature review and equivalence assessment is usually sufficient. From Class IIb onwards, clinical investigations may be required.

Clinical Evaluation Report (CER)

Create technical documentation according to MDR Annex II and III

The technical documentation for medical devices under MDR is significantly more extensive than for other CE-obligated products. It must meet the requirements of Annex II (Technical Documentation) and Annex III (Technical Documentation on Post-Market Surveillance).

Estimated time: 4-12 Wochen

Technical documentation according to MDR Annex II compiledRequired

Content: product description and specification, manufacturing information, design and manufacturing information, general safety and performance requirements (MDR Annex I), risk management file, clinical evaluation, labeling and instructions for use.

Complete technical documentation according to MDR Annex II

Post-Market Surveillance Plan (PMS Plan) createdRequired

The PMS plan describes how you monitor your product after placing on the market: complaint tracking, vigilance reports, periodic safety update reports (PSUR for Class IIa/IIb/III), trend analyses. For Class III and implants: annual PSUR.

Post-Market Surveillance Plan according to MDR Annex III

Instructions for Use (IFU) in German language createdRequired

The instructions for use must meet the requirements of MDR Annex I Chapter III: intended purpose, contraindications, warnings, instructions, residual risks. In German language for the German market. Symbols according to EN ISO 15223-1.

Conformity assessment and Notified Body (from Class IIa)

For Class I products (without measuring function, non-sterile), you can declare conformity yourself. From Class IIa onwards, involvement of a Notified Body is mandatory. Capacity constraints at Notified Bodies can lead to long waiting times.

Estimated time: 4-26 Wochen

Conformity assessment procedure according to MDR Annex IX-XI selectedRequired

Class I: Self-declaration (Annex IV). Class IIa: Quality assurance of production (Annex XI) or type examination (Annex X). Class IIb/III: Full QMS audit (Annex IX) by a Notified Body such as TUeV SUeD, TUeV Rheinland, DEKRA, BSI or SGS.

Notified Body engaged (for Class IIa, IIb, III)

Select a Notified Body designated under MDR. In the EU NANDO database you can check which Notified Bodies are designated for your product category. Expect 3-6 months lead time just for the contract and first assessment.

EU Declaration of Conformity issued and CE marking affixedRequired

The DoC must reference all applied MDR Annexes, the Notified Body number (for Class IIa+), product identification and UDI-DI. The CE mark must be affixed on the product or packaging. When a Notified Body is involved: their four-digit identification number behind the CE mark.

EU Declaration of Conformity according to MDR Article 19

UDI assignment and EUDAMED/DMIDS registration

Every medical device requires a Unique Device Identification (UDI) and must be registered in the European database EUDAMED and in the German DMIDS. The UDI must be applied to the product and packaging.

Estimated time: 1-3 Wochen

UDI-DI and UDI-PI assigned and applied to labelingRequired

The UDI consists of a Device Identifier (UDI-DI, product-specific) and a Production Identifier (UDI-PI, batch or serial number specific). Issuing entities: GS1, HIBCC or ICCBBA. The UDI must appear on the product as AIDC (barcode/2D code) and as HRI (Human Readable Interpretation).

UDI registration certificate from issuing entity

Registration with BfArM / DMIDS completedRequired

In Germany, the BfArM (Federal Institute for Drugs and Medical Devices) is the competent authority. Medical devices must be registered in the DMIDS (German Medical Device Information and Database System). Registration must occur BEFORE placing on the market.

DMIDS registration confirmation

EUDAMED registration completed (when available)Required

EUDAMED is the central EU database for medical devices. The modules for economic operators and UDI/device registration are already available. Manufacturers, authorized representatives and importers must register and enter their products.

Amazon.de listing and compliance requirements

Amazon.de has specific requirements for medical device listings. Certain categories are restricted or require approval. You must upload compliance documents and correctly reflect regulatory information in the listing.

Estimated time: 1-2 Wochen

Category approval for medical devices requested from AmazonRequired

Medical devices on Amazon.de often require category approval. You must submit CE certificate, DoC, Notified Body certificate (if applicable), invoices and product photos. The approval process can take several weeks.

GPSR mandatory fields and compliance documents uploaded in Seller CentralRequired

Since December 2024, Amazon requires GPSR mandatory information: responsible person in the EU, manufacturer data, contact information. Additionally: upload DoC, Notified Body certificate and relevant test reports as PDF. Amazon can request these at any time.

DoC, Notified Body certificate, test reports as PDF in Seller Central

Listing texts checked for regulatory correctnessRequired

Do not use unauthorized medical claims in the listing. The intended purpose in the listing must match the DoC. No healing promises beyond the approved intended purpose. For Class I: no statements implying a higher risk class.

Common Mistakes to Avoid

Falsely marketing a wellness product as a medical device (or vice versa)

Consequence: If a wellness product is marketed with medical claims, it is legally considered an unauthorized medical device – fines up to 30,000 EUR, sales ban. Conversely: selling a medical device without CE marking as a wellness product is consumer fraud.

Prevention: Define the intended purpose before product development. Check all marketing materials, listings and packaging for consistent use. In case of doubt, have a regulatory consultation performed.

Continuing to use CE marking from the old MDD without MDR update

Consequence: The MDD transition period has expired. Products with MDD certificates may only be placed on the market for a limited time depending on their class. New products mandatorily require an MDR conformity assessment.

Prevention: Check the status of your MDR transition. Start updating documentation early. The MDR places significantly higher requirements on clinical evaluation and post-market surveillance than the MDD.

UDI labeling missing or incorrect

Consequence: Violation of MDR Article 27. The product may not be placed on the market. Amazon can suspend the listing if the UDI is missing from product labeling.

Prevention: Register early with a UDI issuing entity (GS1 is most common in Germany). Ensure that UDI-DI and UDI-PI appear on product and packaging both as barcode/2D code and in human-readable form.

Forgetting BfArM/DMIDS registration before market entry

Consequence: Placing on the market without registration with the competent authority violates the MPDG (Medical Devices Implementation Act). Regulatory proceedings and sales ban are the consequences.

Prevention: Register yourself and your product in DMIDS BEFORE listing the product on Amazon.de. Registration is free and done online via the BfArM portal.

Neglecting post-market surveillance after market entry

Consequence: The MDR requires active surveillance even after placing on the market. Without a PMS system, you cannot report vigilance incidents and risk having your CE certificate withdrawn by the Notified Body.

Prevention: Set up a PMS system from the start: monitor Amazon reviews for safety issues, systematically record complaints, submit vigilance reports to BfArM within deadlines (serious: 15 days, trend: 2 days).

Frequently Asked Questions

Q1Is my health product a medical device or a wellness product?

The decisive factor is the intended purpose according to MDR Article 2(1): if the product is intended for diagnosis, treatment, monitoring, prediction, prognosis or alleviation of disease, it is a medical device. A massage device 'for relaxation' is not a medical device. The same device 'for treatment of back pain' is one. The intended purpose is derived from labeling, marketing, listing text and instructions for use – not just the technical function.

Q2Do I need a Notified Body for a Class I medical device?

For standard Class I products, no – you can declare conformity yourself. BUT: Class I products with a measuring function (e.g. fever thermometers) or placed on the market sterile (e.g. sterile wound dressings) require a Notified Body for the respective aspect (measuring function or sterilization process). Check this carefully during your classification.

Q3How much does CE marking cost for a simple Class I medical device?

For a simple Class I product (e.g. elastic bandage, simple plaster): approx. 2,000-8,000 EUR including regulatory consulting, technical documentation, clinical evaluation and DMIDS registration. For Class IIa (e.g. blood pressure monitor), add 5,000-15,000 EUR for the Notified Body. Class IIb/III products can cost 30,000-50,000 EUR and more.

Q4How long does the MDR certification take in total?

Class I without measuring function: approx. 8-16 weeks with good preparation. Class IIa: 16-30 weeks including Notified Body. Class IIb/III: 6-12 months, as the Notified Body performs a comprehensive review and capacity constraints currently exist. For first-time products, always plan at least 6 months lead time.

Q5Can I simply sell a product approved as FDA 510(k) in the USA in the EU?

No. FDA (USA) and MDR (EU) are completely different regulatory systems. An FDA clearance does not replace an MDR conformity assessment. However, test data, clinical data and the QMS (if built according to ISO 13485) can partially be reused, which reduces effort. A gap analysis by an MDR consultant shows which additional requirements must be met.

CE MarkingHealth & MedicalGermany 🇩🇪