EU MDR & IVDR Consultants in Europe

A consultant can help interpret the project, structure a regulatory strategy, assess classification, build or review quality and technical documentation, plan evidence, prepare submissions and remediate gaps. The exact scope should be written into a contract with deliverables, assumptions, responsibilities and acceptance criteria.

No. A consultant is not a competent authority and is not automatically a notified body. Where third-party conformity assessment is required, only an appropriately designated notified body can perform that assessment within its scope. Neither a consultant nor this matching service can guarantee CE marking, certificate issuance, acceptance, cost or timing.

No. Some MDR Class I devices and IVDR Class A non-sterile devices can generally follow manufacturer self-declaration routes when all applicable conditions are met. Class I sterile, measuring and reusable surgical devices involve notified-body assessment for the relevant aspects, and higher classes generally require notified-body involvement. Classification and special product features must be assessed carefully.

The Regulations require manufacturers to establish, document, implement, maintain and continually improve a proportionate quality management system. EN ISO 13485 is widely used to demonstrate a structured approach, but voluntary use of a standard and third-party certification should not be confused with the legal QMS obligation. The appropriate evidence depends on the conformity-assessment route, notified-body expectations, contracts and other market requirements.

Article 15 requires manufacturers to have at least one qualified person responsible for regulatory compliance within their organisation. Micro and small enterprises are not required to have that person internally, but must have the PRRC permanently and continuously at their disposal. Authorised representatives must also have a qualified PRRC permanently and continuously at their disposal. The arrangement, qualifications, availability, authority and conflicts should be documented.

A qualified external specialist can support drafting, literature work, evidence appraisal, study planning and document maintenance. The manufacturer nevertheless remains responsible for the regulatory strategy, data supplied, final conclusions, approvals, document control and ongoing compliance. Clinical or performance work should be assigned to people with demonstrably relevant scientific and device expertise.

There is no universal ‘SaMD class’. Qualification and classification depend on the intended purpose, information provided by the software, clinical context and the applicable MDR or IVDR rules. Changes to algorithms, data, claims, architecture or performance can also affect the regulatory assessment, risk management, validation and post-market plan.

Check the official NANDO information and confirm that the organisation is designated for the Regulation, conformity-assessment activities and product codes relevant to the device. Then assess capacity, application requirements, fee structure, languages, geographic logistics, experience and contractual terms. A famous name is not enough if its designation scope does not cover the project.

Since 28 May 2026, the Actor, UDI/Device, Notified Bodies and Certificates, and Market Surveillance modules are mandatory for the relevant actors and activities. The practical obligation depends on the actor, device and transitional situation. The Vigilance and Post-Market Surveillance module and the Clinical Investigations and Performance Studies module remain subject to the Commission's rollout.

They are generally voluntary. When the reference to a harmonised standard is published in the Official Journal for the MDR or IVDR, applying it can provide a presumption of conformity only for the requirements and conditions covered by that citation. A manufacturer may use another technical solution but must provide suitable evidence that the legal requirements are met.

There is no reliable universal timetable. Duration depends on device qualification and class, maturity of the QMS and evidence, testing, clinical or performance data, supplier inputs, notified-body route, team availability and the number of remediation cycles. Ask for a phased plan with dependencies and decision gates rather than an unsupported promise.

Share the product type, intended purpose, current class or uncertainty, target markets, project stage, existing certificates, requested deliverables and target timing. Do not send patient data, health records, full technical files, proprietary source code, passwords or highly confidential evidence through the first enquiry form. Sensitive material should follow due diligence, an NDA and an agreed secure channel.

A consultant provides contracted expertise. A non-EU manufacturer must designate a sole EU authorised representative for the same generic device group under a written mandate, and that representative has specific legal tasks and potential liability under the Regulations. The same organisation may offer both services, but the roles, contracts, independence and conflicts must be explicit.

We use the structured brief to identify potentially relevant independent specialists and facilitate introductions. You remain responsible for checking qualifications, experience, references, availability, insurance, data-security controls, conflicts, fees and contract terms. European-Standards.com does not replace regulatory, legal, notified-body or competent-authority decisions.