Executive search in medical technology: filling key positions ahead of the MDR revision

According to the BVMed autumn survey 2026, more than 80 percent of medical technology companies are struggling to fill vacancies. The biggest gap is not in regulatory affairs, however, but in sales: 42 percent of companies name it as a bottleneck, compared with only 15 percent for regulatory affairs.

In short: If you fill a key position in medical technology now, you are filling it for the period after the MDR revision. The EU intends to revise the Medical Device Regulation by 2027, and rigid requirements such as the qualification criteria for the person responsible under Article 15 are set to be dropped. What is needed are executives who combine regulatory depth with an understanding of markets and sales, and a selection process that tests exactly that.

What does the BVMed autumn survey 2026 reveal about your staffing situation?

In August and September 2026, the German Medical Technology Association (BVMed) surveyed its members, and 120 of its 220 voting member companies responded. The results of the BVMed autumn survey 2026 show an industry that is growing while struggling under its costs. Revenue in Germany is expected to rise by 3.9 percent. Even so, 45 percent of companies expect falling profits.

For staffing decisions, these figures are the most relevant:

37 percent of companies are adding staff, 38 percent are keeping headcount stable and 20 percent are reducing it.
Recruitment is focused above all on sales (78 percent), followed at a considerable distance by production (26 percent), marketing (25 percent) and research and development (22 percent).
Positions are hard to fill in sales (42 percent), quality management (18 percent), research and development (17 percent) and regulatory affairs (15 percent).
60 percent name rising personnel costs as a cost driver. Only the bureaucratic burden ranks higher, at 63 percent.

One contradiction in the figures stands out. Only 34 percent count the skills shortage among the major problems of Germany as a business location, and yet more than four in five companies are struggling to fill positions. Our reading: in medical technology, the shortage has become the normal state of affairs. Companies have come to terms with it and factor it into their planning.

For you as a managing director or division head, this means one thing above all. Every bad hire becomes twice as expensive, because the position was already hard to fill the first time, and the second search starts from scratch while personnel costs keep rising.

Why does the MDR revision change the requirements profile for your executives?

On 16 December 2025, the European Commission presented its proposal to simplify the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The list of changes is long. Recertification every five years is to be abolished, unannounced audits are to take place less often, and binding deadlines are planned for conformity assessments by notified bodies. Reusable surgical instruments and medical software are in some cases to move into a lower risk class. Products with AI components are to undergo their assessment under the AI Act within the MDR procedures, so that no duplicate structures arise. The Commission puts the expected relief at 3.3 billion euros per year.

None of this has been adopted yet. The European Parliament's health committee has been debating the amendments proposed by rapporteur Oliver Schenk since July. The TÜV-Verband and other associations of testing and inspection organisations warn in an open letter that the plans would come at the expense of patient safety. There are two indications regarding the timetable: in July, the German medical journal Deutsches Ärzteblatt reported that the trilogue negotiations between the Commission, Parliament and Council were to be concluded by the end of 2027, so that the revision could enter into force at the beginning of 2028. In early October, the regulatory consultancy Emergo by UL named adoption in the second or third quarter of 2027 as the target. Until then, the MDR continues to apply unchanged.

For your workforce planning, this leads to an uncomfortable conclusion. If you hire a head of regulatory affairs or quality management today, you need someone who keeps two sets of rules in mind at the same time: the current one and the one to come. According to BVMed, one third of the surveyed companies' investment currently goes into meeting MDR requirements, and only 31 percent into genuine new developments. If the revision is adopted in its proposed form, part of this budget will be freed up. Where it then goes will not be decided by someone who sees their role as a mere documentation obligation.

The person responsible under Article 15: fewer requirements, more judgement

One detail of the proposal directly affects how you select personnel. Under Article 15 MDR, every manufacturer needs a person responsible for regulatory compliance, known in the industry as the PRRC. Among other things, this person ensures that products are checked for conformity before release and that the technical documentation is kept up to date. Today, the regulation specifies the required qualifications precisely: a relevant university degree and at least one year of professional experience in regulatory affairs or quality management, or alternatively four years of professional experience. Micro and small enterprises may outsource the role, provided the person is permanently available.

The Commission wants to delete these detailed criteria. As the VDE points out in its overview of roles and liability for medical device manufacturers, authorities and notified bodies are nevertheless likely to expect comparable evidence. In practice, this shifts the responsibility to you. Where a degree and a number of years used to be enough of a check, you will in future have to judge for yourself whether someone is up to the task. Structured interviews and sound management diagnostics therefore gain in importance, especially as the PRRC in smaller organisations is often also responsible for quality and risk management.

Which positions are hardest to fill in medical technology?

For years, the public debate has revolved around regulatory affairs. BVMed's figures show that sales is the real bottleneck. The reasons go beyond the general skills shortage.

Sales managers in medical technology negotiate with group purchasing organisations and hospital chains, whose price pressure 52 percent of companies describe as a burden. They need to know the reimbursement pathways, because 55 percent feel the cost-cutting measures of the statutory health insurance funds. And increasingly, they need experience outside Europe. 62 percent of the companies surveyed now prefer the FDA's US approval system, up from 56 percent the previous year. Only 9 percent still prefer the MDR, and 9 percent are shifting investment to the USA.

These figures add up to profiles the labour market can hardly supply:

Heads of sales who bring together clinical understanding, experience with group purchasing organisations and international markets
Heads of regulatory affairs who know EU and FDA procedures and treat approval strategy as part of product planning
Heads of quality who can steer a QM system according to ISO 13485 through changed audit and inspection cycles
Heads of development with software and AI experience, especially as 20 percent of BVMed companies already develop their own AI products

How tight the market for such profiles is can be seen from a project we describe in anonymised form on our industry page. A family business with 800 employees, a manufacturer of medical packaging, was looking for a head of sales for South-East Asia. Besides industry experience, the brief called for either someone from Western Europe living in the region or a local executive with experience in German companies. We solved the search together with our network partner in Thailand. The position was filled by a German who lives in Malaysia.

How do you fill a position whose responsibilities will shift by 2028?

The obvious response to so much uncertainty would be to wait until the revision is settled. We advise against this. As things stand, it may take up to a year and a half until the revision is adopted and applies. An executive you only start looking for at that point will often not be able to start until months later because of their notice period. The transition itself also needs someone to lead it. It makes more sense to align the appointment with the transition from the outset.

Four considerations help:

Write the requirements profile with 2028 in mind. What must the role deliver once recertifications are dropped, deadlines apply to notified bodies and budget is freed up from compliance?
Assess judgement as thoroughly as qualifications. When formal criteria such as those for the PRRC disappear, what counts is a proven ability to weigh up regulatory risks and defend that assessment to management and authorities.
Cast the target company list wider. Suitable candidates also work in diagnostics, in laboratory companies, in the pharmaceutical industry or at suppliers with their own QM system. How a systematic direct candidate approach is structured is described in a separate article.
Plan the first months as well. Anyone starting in the middle of a regulatory reform needs fast access to decision-making channels and clear goals for the first 90 days. What matters in onboarding executives is covered in our article on the subject.

How broad a search sometimes has to be is shown by a second project from our industry page. A highly regulated medical technology laboratory company with annual revenue of around 8 million euros and the goal of growing by 15 percent a year needed a new managing director. The brief called for a personality who thinks like an entrepreneur and understands laboratory processes in detail. After a market analysis, we approached more than 100 decision-makers from 70 target companies directly before the right candidate was found.

Frequently asked questions about executives in medical technology

What makes executive search in medical technology different from other industries?

Here, regulation shapes almost every leadership role, including in sales and development. Besides their own specialist field, candidates must understand the logic of the MDR, notified bodies and reimbursement. On top of that, the market is small: 93 percent of medical technology companies are small and medium-sized enterprises, and many specialists know one another. Candidates therefore have to be approached with particular discretion.

Does every medical technology company need its own PRRC?

Every manufacturer needs a person responsible under Article 15 MDR. Micro and small enterprises may engage an external person for this, provided that person is permanently and continuously available. Larger manufacturers must fill the role within their own organisation. The Commission's proposal would above all delete the detailed qualification criteria.

When will the MDR revision enter into force?

That has not yet been decided. The Commission's proposal of 16 December 2025 is currently being debated in the European Parliament and the Council. Adoption is targeted for the course of 2027, and early 2028 has been named as the target date for entry into force. Until then, the MDR applies in its current version.

Should you wait for the revision before filling a head of RA or QM position?

In most cases, no. The current obligations continue to apply until the revision enters into force, and the transition itself has to be managed. A better