Planned EU medtech changes and codified Helsinki procedure support consistent qualification and classification

The qualification and classification of a medical device or diagnostic determine the product's conformity assessment route, the level of notified body involvement and the evidentiary burden on manufacturers.

Since the entry into application of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), divergent qualification and classification decisions across EU Member States have created legal uncertainty and barriers to market access. In addition, the regulations introduced class‑based requirements that have placed significant regulatory strain on manufacturers.

​The European Commission’s legislative proposal introduced on 16 December seeks to amend the existing rules by addressing some of these issues and promoting consistent, risk‑based decisions across the internal market. It would codify the Helsinki procedure for borderline and classification questions at EU level, strengthen the roles of the expert panels and the Commission, and adjust certain classification rules to reduce unwarranted up‑classification.

Qualification and classification background

A product qualifies as a medical device or a diagnostic once it meets either of the definitions provided by the MDR and IVDR, as interpreted by the Court of Justice of the European Union, national courts and applicable guidance enacted by the medical device coordination group (MDCG) and national competent authorities.

Under annex VIII (classification rules) to the MDR and IVDR, medical devices and IVDs are then classified into four risk classes based on intended purpose and inherent risks. For devices, this ranges from class I (low risk) to class III (high risk). For IVDs, classes run from A to D. The classification determines whether a notified body should be involved and, if so, which conformity assessment route applies (annexes IX to XI of the MDR; annexes IX to XI of the IVDR).

The recent MDR and IVDR targeted evaluation found that, in practice, differences in interpretation of annex VIII rules have led to divergent classifications, particularly for borderline products and software. There is also evidence that some rules have unintentionally up‑classified certain device categories, leading to disproportionate certification burdens. As a result, stakeholders who participated in the Commission-led public consultation called for more central coordination and for streamlined, risk‑appropriate classification.

Helsinki procedure codification

To address qualification issues, the proposal introduces new provisions into both regulations, formalising what is commonly known as the Helsinki procedure.

Amended article 4 (regulatory status of products) of the MDR dealing with products' qualification requires competent authorities to coordinate their activities when determining whether a specific product falls within the definition of a medical device or an accessory and to ensure appropriate consultation of relevant authorities and Union bodies where borderline with other product categories is at stake.

New article 4a MDR (opinion on and determination of the regulatory status of a product) then provides a mechanism for opinions on and determinations of regulatory status at EU level. Under this provision, a competent authority, a notified body, a manufacturer, a developer of a product or the Commission may submit a "substantiated request" for an opinion from an expert panel on whether a product (or category/group of products) falls within the device definition. Where the requester considers the product to be a device, the request should also include a proposed classification under annex VIII.

Expert panels would be required to deliver an opinion  without undue delay. Taking that opinion into account, Member States could ask the Commission to determine whether a specific product or category falls within the definition of a medical device. The Commission would then decide by implementing act, which may also specify the applicable classification where relevant. However, this route would not be available where the regulatory status has already been determined under other EU legislation.

Equivalent provisions are set out in the IVDR, concerning IVDs and accessories.

Classification disputes and challenges

Beyond regulatory status, the proposal introduces two complementary MDR provisions: article 51a (classification in the event of a dispute between manufacturer and notified body) and article 51b (challenges to classification of CE‑marked devices). Equivalent IVD measures are introduced as articles 47a and 47b of the IVDR.

The draft provisions establish two classification dispute mechanisms.

First, either a manufacturer or a notified body may refer a classification dispute arising under annex VIII to the competent authority of the Member State where the manufacturer is established (or, if outside the EU, where its authorised representative is established).

Second, a competent authority that considers a CE‑marked device incorrectly classified may initiate a challenge procedure.

In both cases, the authority should consult other Member States within 30 days on its draft decision. If no substantiated disagreement is raised, the authority should adopt its decision within 90 days of the referral. Where a Member State raises a substantiated disagreement, , the case should be referred to an expert panel , which would issue a classification opinion within 30 days; the competent authority should then adopt its decision and notify the other Member States and the Commission. 

The Commission would be empowered to adopt implementing acts setting out further procedural details.

Publication and transparency 

The proposed amendments to the MDR would impose a duty on competent authorities to coordinate their activities when determining the classification of a device, or a category or group of devices. Results of this coordination, including decisions or measures adopted by the authorities and opinions issued by expert panels in relation to classification, would be made publicly available, subject to the protection of confidential information. Corresponding provisions in the amended IVDR would require publication of coordination outcomes and expert panel opinions concerning regulatory status and classification.

Targeted down classification

Key amendments to the aforementioned annex VIII MDR and IVDR, include targeted down‑classification measures, in line with the simplification and proportionality objectives.

For reusable surgical instruments, the amendments confirm that these devices remain class I, but clarify that notified body involvement is limited to aspects of reprocessing (cleaning, disinfection, sterilisation) where necessary.

Amended article 52 (conformity assessment procedures) of the MDR states that for class I devices placed on the market sterile, with a measuring function, or as reusable surgical instruments, the manufacturer should apply the relevant sections of annex IX or annex XI. However, the proposal offers manufacturers additional flexibility by clarifying that where the manufacturer of class I reusable surgical instruments has applied harmonised standards or common specifications covering all relevant aspects, the involvement of a notified body is not required.

For accessories to active implantable medical devices, the classification rules are adjusted so that accessories not directly determining implant performance may fall into lower classes, reducing the need for full class III pathways where disproportionate.

For software, while the basis of classification rule 11 remains, the Commission signals that certain software products whose outputs are less directly linked to critical patient outcomes may be classified in lower classes. If the direction is confirmed, future delegated acts adopted under the MDR and guidance via the MDCG are likely to operationalise this transition.

The proposal complements these procedural tools with substantive flexibility. The amended MDR and IVDR both empower the Commission to adopt delegated acts amending annex VIII either to adapt it to technical or scientific progress or to take into account developments regarding classification of devices at international level.

It is hoped that this measure would allow the EU to respond to emerging technologies and international convergence efforts (for example, within the international medical device regulators forum) without needing a full legislative revision. It would also allow the EU to reflect lessons learned from Helsinki procedure outcomes.

Expert opinions

The new Helsinki architecture gives manufacturers more structured options to seek EU‑level clarity. The revised regulations would enable manufacturers and developers to request expert panel opinions on regulatory status and classification questions at an early stage, including before CE‑marking. They (or their notified bodies) can trigger a classification dispute procedure where they disagree with a notified body's interpretation of the MDR or IVDR's annex VIII.

On the other hand, expert panels are tasked with providing opinions within defined timelines and to publish them (with confidentiality safeguards). The opinions are not formally binding on manufacturers or notified bodies in all contexts, but competent authorities should consider them when taking decisions. Similarly, the Commission may draw on them in adopting implementing or delegated acts.

Osborne Clarke comment

The codification of the Helsinki procedure would represent a significant advance in legal certainty, transforming what was previously a more informal coordination forum into a set of justiciable EU‑level mechanisms. For medtech stakeholders, this could offer clearer routes to resolve difficult classification and borderline questions and to challenge, indirectly, inconsistent interpretations.

The combination of expert panel opinions, public transparency of outcomes and Commission powers to adapt annex VIII (classification rules) of the MDR and IVDR could, over time, build a de facto body of "case law" on classification. This may make it easier to predict how novel products will be treated, particularly where international comparators exist. It could also, however, make it harder to argue for bespoke classifications that diverge from emerging consensus.

The targeted down‑classification of reusable surgical instruments and certain accessories and software appears consistent with the broader proportionality agenda and may help free up notified body capacity. Manufacturers with products in these categories may wish to monitor how these provisions evolve during the legislative process and consider assessing whether their current classifications and conformity assessment routes could be optimised in light of the new rules.

However, as the proposal remains subject to negotiation between the European Parliament and the Council, the final text will likely differ from the current draft, and stakeholders should avoid drawing definitive conclusions until the legislative process is complete. At the same time, care should be taken not to over‑interpret the potential for down‑classification; devices whose failure could cause serious harm are likely to remain firmly in higher classes, regardless of digital or hardware form.