An EU conformity assessment that consistently integrates documentation and enables long-term management of changes — all from a single source, for medical devices (classes I–III) and in-vitro diagnostic medical devices (classes A–D). A cohesive approach rather than isolated, last-minute activities just before submission.
MDR/IVDR expertise since 2017 · MD classes I–III & IVD classes A–D · Documentation from a single sourceMetecon helps manufacturers structure their EU conformity assessment process so that evidence, responsibilities, and regulatory requirements work together consistently. We organize work packages, documentation, and interfaces so that development, quality management, technical documentation, and regulatory requirements mesh seamlessly. Throughout the project, we help set priorities early on, identify gaps in a timely manner, and organize supporting documentation so that changes and further developments remain manageable. The goal is a robust framework for market access and product maintenance, rather than isolated, one-off activities right before submission.
The added value begins early—starting in the concept and development phase—and is particularly relevant prior to submission, as well as on an ongoing basis during changes and maintenance throughout the product life cycle. Those who wait until shortly before submission to establish the documentation structure pay the price in the form of time pressure, rework, and avoidable additional requirements. Those who establish it early gain control and maintain a clear thread of consistency even when product changes occur. It is precisely this perspective—viewing documentation as a coherent, maintainable system rather than a collection of individual documents—that distinguishes Metecon’s support from a purely document-oriented approach.
"An EU conformity assessment that consistently links evidence and makes changes manageable over the long term."
Requirements and supporting documentation are developed separately—gaps become apparent shortly before submission. Metecon establishes the documentation structure early on and maintains it consistently.
Technical Documentation →
Results from development, quality management, risk, and regulatory affairs do not consistently align. We integrate them into a coherent argument.
Risk Management →
Further developments trigger a high volume of coordination and rework because documentation structures are not organized. We make changes manageable.
QMS & Auditing →
Metecon provides end-to-end, field-proven support throughout the conformity assessment process: MDR/IVDR expertise since 2017, class I–III medical devices and class A–D in-vitro diagnostic medical devices, with well-founded justifications for the classification and consistently reviewed files. Because technical documentation, risk management, clinical and performance evaluation, quality management, and verification & validation all converge at Metecon, a consistent body of evidence is created instead of numerous individual pieces of evidence—precisely where manufacturers would otherwise risk receiving additional requests during the conformity assessment.
The practical difference becomes apparent during the process: When risk acceptance, clinical conclusions, GSPR evidence, and technical documentation all follow the same logic, questions from the Notified Body can be answered quickly and without contradictions. It is precisely this consistency that shortens turnaround time, reduces the need for rework, and makes market access predictable. To achieve this, Metecon brings not only regulatory expertise but also experience from numerous conformity assessments across all risk classes—and applies it to the specific characteristics of your product.
Accurate classification according to MDR/IVDR and selection of the appropriate conformity assessment procedure.
Consistent verification logic with traceability across all departments.
Consistent structure and maintenance of technical documentation as the key to success.
Structured proof of the essential safety and performance requirements.
Audit preparation and gap analysis before the Notified Body conducts its audit.
Prepare the declaration of conformity and ensure that supporting documentation remains consistent when changes are made.
Metecon’s EU conformity assessment service is primarily aimed at Heads of Regulatory Affairs and Regulatory Affairs Managers, as well as R&D and technical leaders who want to structure their documentation early on and keep it under control. Secondarily, it is aimed at executive and management teams, for whom sales and delivery capabilities must be quantifiable.
In all cases, the follwoing applies: the the verification logic is established, the less time and effort will be required later for coordination and rework.
Develop evidence and regulatory arguments in a consistent and transparent manner. More →
Consistently integrate risks, measures, and supporting evidence. Learn more →
Evidence tailored to the intended purpose and product justification. More →
Embed processes, responsibilities, and record-keeping within the organization. More →
Reliably link requirements and risks to a testing strategy and results. Learn more →
Use EU certifications as the basis for international market strategies. Learn more →
The effort involved depends on: product class (MDR I–III / IVDR A–D), product maturity, the extent of existing gaps, and the target markets. Following a free initial consultation, you’ll receive a transparent, fixed-price quote. Speak directly with Milan Weiß, Sales Manager at Metecon—even a brief initial discussion will help clarify the best path forward.
For medical devices, the conformity assessment determines whether a product may bear the CE mark and be marketed in the EU. The challenge rarely lies in a single requirement, but rather where classification, evidence, and responsibilities intersect. Metecon gets involved as early as the design and development phase and structures the evidence framework so that it remains valid through the submission process and throughout the entire product life cycle.
The path to the CE mark follows a clear structure: intended purpose, classification, selection of the conformity assessment procedure, demonstration of compliance with essential safety and performance requirements, technical documentation, involvement of a Notified Body if necessary, and finally, the declaration of conformity. The key is not to address each of these building blocks in isolation, but to link them in such a way that they refer to one another and support each other. Metecon holds this chain together—and ensures that the regulatory rationale remains transparent at every stage.
This page focuses on medical devices (MDR). Are you looking for the section on in-vitro diagnostic medical devices? Go to EU conformity assessment for in-vitro diagnostic medical devices (IVDR) →
The risk class according to Annex VIII of the MDR determines the conformity assessment procedure. Manufacturers place class I products (excluding special cases) on the market under their own responsibility; for classes Is/Im, IIa, IIb, and III, a Notified Body must be involved. Depending on the class, the procedures set forth in Annex IX (quality management system and assessment of technical documentation), Annex X (type examination), or Annex XI (product conformity) may apply. We clearly derive the choice of procedure from the intended purpose and classification and provide a transparent justification so that it stands up to scrutiny during an audit.
The following overview shows the basic structure of the MDR conformity assessment procedures by risk class. Metecon clearly determines which procedure is best suited for each individual case based on the intended purpose and classification.
| Class (MDR) | Typical Procedure | Notified Body | Core certification |
| I | EU declaration of conformity on one’s own responsibility | No | Technical documentation in accordance with Annexes II and III |
| Is / Im / Ir | Technical documentation in accordance with Annexes II and III | Annex IX, Chapters I and III, including testing of the specific aspect | Annex XI, Part A (Production Quality Assurance) | Yes (sterility / measurement function / reprocessing) | TD + aspect verification |
| IIa | Technical documentation in accordance with Annexes II and III and Annex XI, Part A (Production Quality Assurance) or Annex XI, Part B (Product Testing) | Annex XI, Chapters I and III | Yes | QMS + technical documentation |
| IIb | Annex IX (assessment of QMS + technical documentation, Chapters I, III (II only for implants) or Annexes X + XI | Yes | QMS + technical documentation |
| III | Annex IX (assessment of QMS + TD, Chapters I–III) or Annex X + XI (Part A or Part B) | Yes | QMS + complete TD review |
For classes IIa, IIb, and III, there is a genuine choice that should be based on various considerations. These include strategic and economic considerations that depend, for example, on the product class, product type, target markets outside the EU, and internal requirements. We provide support in the decision-making process to identify the optimal conformity assessment procedure for each product.
At the heart of the documentation process are the General Safety and Performance Requirements (GSPR) set forth in Annex I of the MDR. We structure the GSPR checklist so that each requirement is linked to the appropriate supporting documentation—standards, verification, risk management, clinical evaluation. Instead of a simple checklist, this creates a robust rationale that demonstrates how and with which proof each requirement is met. This reduces the need for follow-up questions and identifies gaps early on. In practice, we keep the GSPR checklist continuously and transparently up to date: Each requirement is assigned a clear status, a rationale, and a reference to the corresponding supporting documentation. If a piece of supporting documentation changes, it is immediately clear which requirement is affected—a key component for maintaining consistency in the assessment throughout the product life cycle.
The technical documentation (Annex II) and the post-market surveillance documentation (Annex III) are prerequisites for successful product registration. Metecon structures the files as a cohesive whole in which intended purpose, classification, risk management, verification & validation, and clinical evaluation are presented in a consistent and non-contradictory manner. This common thread ensures document consistency —and prevents contradictory evidence from arising when changes are made .
Before and during the involvement of the Notified Body, Metecon prepares the technical documentation so that it is verifiable and internally consistent (NB Readiness). We assist in responding to inquiries, structure communication, and ensure a consistent line of reasoning. The end result is the EU declaration of conformity, through which the manufacturer declares the conformity of its product and can affix the CE mark in compliance with legal requirements. Thorough preparation for the Notified Body’s assessment pays off in two ways: it shortens the duration and reduces the number of follow-up inquiries, which tie up already limited assessment capacity and internal resources. Metecon addresses identifiable gaps before they arise during the assessment.
Upon completion of the conformity assessment procedure, with or without a Notified Body, the manufacturer issues the EU declaration of conformity. In doing so, the manufacturer declares, on its own responsibility, that the product in question meets all applicable requirements of the MDR. The EU declaration of conformity is a prerequisite for affixing the CE marking. It documents that a complete conformity assessment procedure in accordance with Article 52 of the MDR has been completed and provides transparency for economic operators (distributors, importers, authorized representatives), who, in turn, fulfill their obligations under the MDR based on the EU Declaration of Conformity.
Product changes, new critical suppliers, or changes to standards must be evaluated in terms of their impact on product safety and performance, as well as their regulatory implications. We assess planned changes in advance to determine their impact, clarify what constitutes a significant change, and ensure that technical documentation, certificates, and supply capabilities remain consistent. This allows us to maintain control over product compliance throughout the entire life cycle, rather than letting changes become a recurring major challenge.
Product changes, new critical suppliers, or changes to standards must be evaluated in terms of their impact on product safety and performance, as well as their regulatory implications. We assess planned changes in advance to determine their impact, clarify what constitutes a significant change, and ensure that technical documentation, certificates, and supply capabilities remain consistent. This allows us to maintain control over product compliance throughout its entire life cycle, rather than letting it become a recurring major challenge.
Regardless of the product classification, all manufacturers must establish a quality management system, which must be certified to ISO 13485 when a conformity assessment procedure under Annex IX or XI is applied. The QMS is therefore not a separate issue, but rather the organizational framework within which evidence is generated, reviewed, and maintained. We ensure that processes, responsibilities, and records are implemented in such a way that a successful conformity assessment procedure can be carried out and that the products meet the conformity requirements throughout their entire life cycle. It is precisely this alignment between documentation and practice that makes a difference during the audit.
Manufacturers generally place Class I products on the market on their own responsibility—without a Notified Body. However, the special cases Is (sterile), Im (measuring function), and Ir (reusable surgical instruments) require the involvement of a Notified Body specifically for these aspects. It is precisely in these cases that manufacturers underestimate the effort involved because they incorrectly classify their product as “only Class I.” Metecon reviews the classification, provides a clear and transparent justification for it, and thus prevents an incorrect classification from later leading to inquiries, delays, or a marketing suspension.
The GSPRs are the key requirements that a medical device must meet in order to obtain the CE marking. The manufacturer must demonstrate, for each applicable GSPR requirement, that the product meets that requirement. Verification and validation (V&V) are the primary methods for providing this demonstration. Metecon ensures that V&V forms the evidence-based core of the conformity assessment process, that objective evidence is generated, and that it is integrated into risk management, usability testing, and other QMS processes.
Most additional requests and inquiries during the conformity assessment involving a Notified Body do not arise from missing individual documents, but rather from inconsistencies between the documents: A risk assessment that does not align with the clinical statement; GSPR evidence that refers to a specification not provided; an intended purpose that is worded differently in the technical documentation and the instructions for use. Metecon systematically checks for this consistency in its gap analysis and resolves such inconsistencies before the Notified Body identifies them—which shortens the process and conserves resources.
Clinical evaluation under the MDR is not a separate process, but rather an integral part of the conformity assessment: It provides evidence that the product is safe, effective, and suitable for its intended purpose. We ensure the interfaces between clinical evaluation, risk management, and technical documentation so that clinical claims, risk acceptance, and GSPR evidence are consistent. This creates a coherent chain of reasoning that stands up to audit scrutiny and can be specifically updated in light of post-market findings.
Data must continue to be collected even after the product has been placed on the market. The MDR requires active monitoring of the product’s safety and performance—even after the product has been placed on the market (post-market surveillance, PMS). A structured process is required, including a PMS plan and various reports, such as the Periodic Safety Update Report (PSUR), which must be updated regularly, a closed-loop feedback mechanism back to risk management, and, for example, the clinical evaluation. Metecon establishes these process interfaces from the very beginning, ensuring that new data is evaluated in a structured manner and used to update the development file and the technical documentation. As a result, changes do not pose a threat to compliance—and thus to the registration status—but are instead incorporated into a controllable, documented process.
The IVDR introduces fundamental changes for most in-vitro diagnostic medical devices: While under the old directive most IVDs were placed on the market under the manufacturer’s own responsibility, today a Notified Body must be involved for the majority of products. Furthermore, additional data must be collected to meet the general safety and performance requirements of the IVDR. Metecon conducts GAP analyses and structures the processes and documentation so that they meet the requirements while remaining manageable.
For many manufacturers, the IVDR’s conformity assessment requirements pose a challenge: Products that previously did not require a Notified Body now undergo a formal procedure with significantly higher documentation requirements. This applies not only to new products but also to established products in the portfolio that must be re-evaluated under the IVDR. We help make this transition manageable—with clear priorities, early identification of gaps, and a documentation structure tailored to the device class and intended use.
Annex VIII of the IVDR contains classification rules for IVDs, which assign them to classes A through D. Depending on the risk class, different conformity assessment procedures may be applied. Class A products may be placed on the market by the manufacturer without the involvement of a Notified Body. For class A sterile (As) as well as classes B through D, the procedures set forth in Annex IX (Quality Management System and Assessment of Technical Documentation), Annex X (Type Examination), or Annex XI (Product Conformity) may be applied. In addition, there are special regulations for products intended for self-testing, for near-patient testing, and for companion diagnostics. For some products, the involvement of a reference laboratory is required. We clearly derive the choice of procedure from the intended purpose and classification and provide a transparent justification so that it stands up to audit scrutiny.
Performance evaluation to demonstrate scientific validity (correlation between the analyte and the clinical/physiological state), as well as analytical performance (correct detection of an analyte) and clinical performance (correlation between result and clinical status), is the core process of product validation for confirming the intended purpose. The processes of product development, performance evaluation, risk management, usability engineering, and verification & validation are closely interlinked, and the resulting data form the basis for the technical documentation. Metecon integrates these processes so that the regulatory rationale is sound and a successful conformity assessment is possible.
Certain high-risk class D products are subject to testing by an EU reference laboratory (EURL). The laboratory verifies the performance specified by the manufacturer and the selected verification methods (e.g., common specifications) and conducts random sampling of class D products or batches of such products. Metecon assists with the timely integration of the EURL into the manufacturer’s processes to prevent bottlenecks in the conformity assessment process. Even after the conformity assessment is complete, the use of an EURL may still be mandatory, such as in the case of mandatory batch testing. To prevent delivery interruptions or delays, Metecon assists in the optimal integration of EURL activities into the manufacturer’s processes.
The IVDR also requires post-market surveillance (PMS) of the product. PMS serves to identify any risks that may arise and only become apparent during routine use and to confirm the product’s ongoing performance. The process is an integral part of the QMS, and the data collected on a product’s quality, performance, and safety feeds back into, for example, risk management and post-market performance follow-up (PMPF), and could lead to updates to the design and the technical documentation. Metecon provides support in implementing an appropriate control loop and in preparing the required plans and reports—ensuring that evidence of conformity remains up-to-date and verifiable.
Even under the IVDR, conformity does not end with placing a product on the market: Post-market performance follow-up (PMPF), surveillance, and vigilance continuously feed data back into the performance evaluation. This feedback loop must be organized so that new findings strengthen the evidence rather than undermine it. Metecon sets up the control loop so that post-market data flows back in a structured manner into the PER (performance evaluation report), risk management, and technical documentation—ensuring that the evaluation remains up-to-date and verifiable.
Since 2022, certain IVDR requirements—such as post-market surveillance, vigilance activities, and the registration of economic operators and products—have applied to all IVD classes. Depending on the risk class, transitional periods apply for the full implementation of the IVDR for some IVDs. Metecon conducts gap analyses and provides support in adapting QMS processes to the IVDR requirements. This enables data for conformity assessment to be collected in a timely and structured manner. The processes are optimized to ensure that data from post-market surveillance can continue to be utilized effectively in the future. It is important not to view the deadlines merely as a breather: Those who use the available time to optimize processes and collect missing data—and thus thoroughly prepare for product registration—will avoid unnecessary problems when working with their Notified Body.
Special requirements apply to companion diagnostics (CDx) and software classified as standalone in-vitro diagnostic medical devices within the framework of conformity assessment. For example, CDx performance studies must be reported to the competent authority, even if only residual samples are used. An ethics committee review is also mandatory. Specific issues related to IVD software include software life cycle processes (IEC 62304) and cybersecurity. Metecon takes these requirements into account and integrates them into the conformity assessment processes in a way that prevents unnecessary delays. Particularly in the case of adaptive or AI-based algorithms, we also clarify early on how changes to the model are to be assessed from a regulatory perspective and embed this logic directly into the evidence structure.
Many IVDs were already on the market under the old directive and must be re-evaluated under the IVDR—often with significantly higher documentation requirements. A structured gap analysis identifies which evidence is available, which needs to be updated, and which must be newly generated. Based on this, Metecon prioritizes a robust roadmap to ensure that existing products retain their market access wherever possible, and that not all products undergo reevaluation simultaneously and in an uncoordinated manner.
The IVDR provides for the creation of common specifications (CS), which are not standards but define technical and/or clinical requirements and enable manufacturers to comply with their legal obligations by adhering to the CS. There are currently a number of CSs for class D devices. Metecon ensures that applicable CSs are identified early on and that compliance with the requirements is documented in the PER. This helps avoid unnecessary delays and costs.
It is advisable to strategically plan the registration of existing and new products in accordance with the IVDR. If the technical documentation is not internally consistent and the evidence of conformity is incomplete or inconsistent, this will lead to inquiries from the Notified Body and, consequently, to unplanned delays. Metecon prepares the technical documentation so that it is ready for review (NB readiness), prioritizes critical paths, and maintains structured communication with the Notified Body—ensuring that the process does not get bogged down by avoidable gaps and inconsistencies.
Irina Waal gained many years of regulatory experience on the manufacturer side—most recently as Team Lead for Quality Systems—and is now a PRRC at Metecon and part of the Regulatory Affairs & Technical Documentation team. The team’s areas of expertise include regulatory management and technical documentation for complex conformity assessments—for class I–III medical devices and class A–D in-vitro diagnostic medical devices. The focus is on structuring documentation early on and maintaining consistency throughout the entire product life cycle.
Meet all the experts →"We structure our documentation so that it works together consistently and changes remain manageable—that is the core of a robust conformity assessment."
Irina Waal, Expert Quality Management & Regulatory Affairs, PRRC, Metecon
Representative, anonymized case studies from conformity assessment projects.
Initial Situation: Classification unclear, GSPR documentation incomplete.
Approach: Classification clearly justified; GSPR established as a living document; procedures prepared in accordance with Annex IX.
Result: Consistent, audit-ready rationale.
Initial Situation: Evidence from performance evaluation, risk management, and technical documentation was inconsistent.
Approach: Consistent documentation logic, gap analysis, NB readiness.
Result: Audit-ready documentation without uncoordinated rework.
Ideally, starting in the design and development phase. Those who establish the verification logic early on can identify critical gaps in a timely manner and prevent inconsistencies from becoming apparent just before submission. Metecon sets priorities early and structures the verification process so that it remains effective throughout the entire life cycle.
Through a modular, traceable documentation structure and clear interfaces between development, risk management, technical documentation, and quality management. This makes it possible to assess the regulatory impact of a change on the product and the QMS before it is implemented—ensuring that the technical documentation remains consistent.
Technical documentation, risk management, clinical and performance evaluation, quality management, and verification and validation must be seamlessly linked through a common thread. Metecon optimizes these processes to ensure efficient interaction, so that performance, safety, and intended use (including claims) align seamlessly.
A conformity assessment is the legally required procedure used to verify and document whether a product meets the applicable requirements, in particular the general safety and performance requirements of the MDR/IVDR. It is a prerequisite for access to the EU market and for the CE mark. Medical devices and IVDs may only be placed on the market in Europe after this procedure has been completed.
Common issues include inconsistent documentation, incomplete coverage of essential safety and performance requirements, and discrepancies between risk management, technical documentation, and clinical evidence. Metecon verifies this consistency through a gap analysis and closes gaps before the Notified Body identifies them.
Deviations should be analyzed and categorized by topic. This allows for the targeted supplementation of missing evidence without creating additional inconsistencies in the documentation. Communication with the Notified Body should follow internally established rules (e.g., communication only through designated employees). Metecon helps ensure that responses are prepared in a consistent and traceable manner so that the process is not further delayed.
It includes the classification of the product, the selection of the appropriate conformity assessment procedure, demonstration of compliance with the general safety and performance requirements, the technical documentation, the involvement of a Notified Body if necessary, and finally, the Declaration of Conformity and CE marking.
The effort and scope depend on the type of product, the product class, the product's maturity, and the extent of existing gaps. Following a free initial consultation, Metecon will provide you with a transparent cost estimate.
Whether it’s classification, selecting procedures, NB readiness, or change control—we’ll work with you to build a documentation framework that functions consistently and remains manageable.
Your contact:
Milan Weiß
Sales Manager
T: +49 621 123469-040
milan.weiss@metecon.de
